PRE-FEASIBILITY REPORT

ACTIVE PHARMACEUTICAL INGREDIENTS [API] AND NOVEL DRUG DELIVERY SYSTEMS [NDDS] UNIT

AT

191- A,1ST STAGE,KIADB INDUSTRIAL AREA,

VASANTHANARASAPURA,TUMKUR - 572128

K A R N A T A K A – INDIA .

Project Promoter: Samarth Life Scienc es Private L i m i t e d .

TUMKUR - 5 7 2 1 2 8

Prepared by Samarth Life Sciences Private Limited. TUMKUR-572128

0

CONTENTS

CHAPTER 1 EXECUTIVE SUMMAR 4

CHAPTER 2 INTRODUCTION OF THE PROJECT 7

2.1 INTODUCTION 7

2.2 BRIEF DISCRIPTION OF NATURE OF THE PROJECT. 7

2.3 NEED FOR THE PROJECT 9

2.4 DEMAND SUPPLY GAP 9

2.5 EXPORT AND IMPORT MARKETS 10

2.6 EMPLOYMENT GENERATION 11

CHAPTER 3 PROJECT DESCRIPTION 12

3.1 TYPE OF PROJECT 12

3.2 LOCATION OF THE PROJECT 13

3.3 DETAILS OF ALTERNATE SITES 16

3.3.1 Project Cost 17

3.4 PROJECT DESCRIPTION 17

3.4.1 Complete Process Detais 17

3.5 MAJOR RAW MATERIALS 134

1

3.6 WASTE CONSUMPTION 138

3.7 WASTE GENERATION AND MANAGEMENT 150

3.8 POWER REQUIREMENTS 153

CHAPTER 4 SITE ANALYSIS 151

4.1 ROAD CONNECTIVITY 151

4.2 TOPOGRAPHY 151

4.3 LAND USE 151

4.4 GEOLOGICAL SETTING 152

4.5 SOIL CLASSIFICATION 152

4.5.1 Water Environment 155

4.5.2 Ground Water 155

4.5.3 Occurrence And Movement Of Ground Water 156

4.5.4 Ground Water Quality 157

4.5.5 Ground Water Quality Observation 159

4.5.6 Ground Water Quality Observation Chart 159

4.5.7 Surface Water Quality 160

4.6 CLIMATE DATA 162

4.6.1 Winds 163

4.6.2 Cloudness 163

2

4.6.3 Ambient Air Quality 134

4.6.4. Noise Level Survey 169

4.6.5 Biological Survey 171

4.6.6 Socio-Economic Environment 172

4.7 SOCIAL INFRASTRUCTURE AVAILABLE 174

CHAPTER 5 PLANNING BRIEF 175

5.1 PLANNING CONCEPT 175

5.2 POPULATION PROJECTION 176

5.3 LAND USE PLANNING 177

5.4 ASSESSMENT OF INFRASTRUCTURE DEMAND 180

5.4.1 Importance Of Physical Infrastructure 181

5.4.2 Importance Of Social Infrastructure 181

5.5 FACILITIES 182

CHAPTER 6 PROPOSED INFRASTRUCTURE 183

6.1 AREA 183

6.2 GREEN BELT 183

6.3 SOCIAL INFRASTRUCTURE 184

6.4 CONNECTIVITY 185

6.5 DRINKING WATER MANAGEMENT 185

3

6.6 INDUSTRIAL WASTE MANAGEMENT 186

6.7 SOLID AND HAZARDOUS WASTE MANAGEMENT 186

6.8 POWER REQUIREMENT 188

CHAPTER 7 REHABITATION AND RESETTLEMENT 189

CHAPTER 8 PROJECT SHEDULE AND COST ESTIMATES 191

CHAPTER 9 ANALYSIS OF PROPOSAL 192

CHAPTER – 1 EXECUTIVE SUMMARY

Sl. No. Item Details

1 Plot/Survey/Khatha No. M/s. Samarth Life sciences Pvt. Ltd., Plot no.191-A, KIADB Industrial area 1st stage, Vasanthanarasapura, KoraHobli, Tumkurtq. and dist.- 572128 2 Contact details

3 E mail id [email protected]

2 Village Vasanthanarasapura

3 Hobli/Taluk KoraHobli

4 District TumkurDistrict

5 State Karnataka

6 KIADB Industrial Area KIADB Industrial area 1st stage

7 Project type The proposed manufacturing unit to produce bulk drugs project for API products.

4

EXPANSION DETAILS

Sl. Existing In API Proposed in ECB No proposed

01 Aprotinin Heparin BP Sodium Recombinant Human Chorionic Gonadotrophin

02 Enoxaparin Hyaluronid Sodium Recombinant Human Follicle Stimulating Hormone ase IP

03 Chorionic Sodium Gonadotrop Hyaluronate Recombinant Human Luteinizing Hormone hin IP

04 Menotrophi Protamine Recombinant Human Factor VIII n BP Sulphate

05 Heparin Recombinant Human Erythropoietin Streptokina Calcium se IP

06 Urokinase Dalteparin Rituximab (Monoclonal Antibody) IP Sodium

07 Protamine Nandroparin Trastuzumab Sulphate Sulphate USP

08 Somatostatin Cetuximab

09 Calcitonin Bevacizumab

10 Bivalirudin Panitumumab

11 Leuprolide Itolizumab

12 Octreotide Nimotuzumab

13 Erythropoietin alpha

14 Recombinant tissue plasminogen activator(Alteplase)

5

15 Interferon α-2

16 Recombinantgranulocyte macrophage colony stimulating factor (GMCSF) 17 Recombinant human Insulin

18 Recombinant human albumin

19 Recombinant somatropin

LIST OF RAW MATERIALS Sl. Materials Quantity No. 1 Glycosaminoglycan 517.5kgs. 2 Methanol 18200Ltrs. 3 Isopropyl alcohol 8800Ltrs. 4 Sodium chloride 60kgs 5 Acetone 3700Ltrs. 6 Cleaning Solution 520 Ltrs. 7 Peptidoglycans 100 kgs 8 Mucopolysaccharide 25 kgs 9 MDC 4800Ltrs 10 Calcium Chloride 5 kg 11 Sulphuric acid 4 ltrs 12 Somatostatin 60 % 2.5 kg 13 Trifluroacetic acid 25 ltrs 14 Chloroform 100 ltrs 15 Acetic acid 25 ltrs 16 Calcitonin 60% 2.5 kgs 17 Bivalirudin 60% 2.5 kgs 18 Leuprolide60% 2.5 kgs 19 Octreotide60% 2.5 kgs 20 Sodium Phosphate 12.5 kg Monobasic 21 Sodium Phosphate Dibasic 12.5 kg

6

CHAPTER – 2

INTRODUCTION OF THE PROJECT

2.1: INTODUCTION:

Biopharmaceutical facility engaged in manufacture of therapeutic substances from natural sources. We had obtained consent for manufacturing of Bulk drugs/ API from natural sources. The product to be manufactured is Apritinin BP, Hyaluronidase IP, Chrionic Gonadotrophin IP, Menotrophin BP, Streptokinase IP, Urokinase IP, and Protamine Sulphate USP.

2.2: BRIEF DESCRIPTION OF NATURE OF THE PROJECT Biopharmaceutical facility engaged in manufacture of therapeutic substances from natural sources. We had obtained consent for manufacturing of Bulk drugs/ API from natural sources. The product to be manufactured is Apritinin BP, Hyaluronidase IP, Chrionic Gonadotrophin IP, Menotrophin BP, Streptokinase IP, Urokinase IP, and Protamine Sulphate USP. The proposed project is modification and addition API and ECB recombinant products. The nature of product in the expansion phase is 1) To manufacture products by rDNA technology 2) To manufacture biological products using solvent extraction

PROMOTORS AND THEIR BACKGROUND:

1 In the year 2006, M/s. Samarth Life Sciences R & D Center [Bangalore], started out by specializing in Research and Development of Active Pharmaceutical Ingredients [API] and Novel Drug Delivery Systems [NDDS]. Over the years, the organization has grown to encompass wide variety of pharmaceutical API Natural Active Ingredients and Biopharmaceuticals and NDDS – Liposomal and Polymer based Drug Delivery Systems. 2 SAMARTH BIOLOGICALS was started in the year 2010 with emphasis on Biotechnology. It is the clear goal to create a progressive and scientifically oriented 7

company, which is built upon a firm commitment to technology and innovation in all its operating divisions. SAMARTH BIOLOGICALS is aided in its manufacturing operations for API by M/s. Samarth Pharma Private Limited, with its facility in Mumbai and for formulations by M/s. Samarth Life Sciences Private Limited with its facility in Nalagarh, Himachal Pradesh.

3 SAMARTH BIOLOGICALS LLP manufactures specific range of Active Pharmaceutical Ingredients [API] belonging to the therapeutic fields of anti-coagulants, anti-fibrinolytics, haemostatics, gonadotrophic hormones, anti-neoplastics and anti-infectives.

OUR PHILOSOPHY VISION:

I. As a developer of API, SAMARTH BIOLOGICALS shall strengthen customer’s position in pharmaceutical, diagnostic and biochemical industry by anticipating market trends and responding with innovative technological solutions. II. To emerge as a leading biopharmaceutical developer, SAMARTH BIOLOGICALS shall develop and produce biopharmaceuticals, thereby enabling newer and innovative solutions to reach the needy at the earliest. III. As a developer of NDDS, SAMARTH BIOLOGICALS shall provide safer, effective and affordable solutions in critical care segment of healthcare, so that common man benefits from these technological solutions.

TEAM: SAMARTH BIOLOGICALS would like to combine its broad scientific expertise with the creative thought processes of skilled marketing force in delivering the right product at right time.

SAMARTH BIOLOGICALS derives inspiration from the well-earned reputation of its parent organization M/s.Samarth Life Sciences Private Limited for efficient and ethical practices in serving human kind.

Values: SAMARTH BIOLOGICALS practices the following five core values:

Knowledge: They understand customers, their needs and apply our extensive knowledge and rich experience in supporting them.

8

Talent: They employ talented individuals who reflect the passion and proficiency to support customers. They provide world-class products and strive to become the reliable partner for our customers

Strength: They are capable to provide customised solutions in a short time; this guarantees ease and convenience to our customers.

Expertise: Their core expertise is our high quality benchmarks, state-of-the-art manufacturing facilities, and our R&D centre which enable us to deliver excellence for driving our standing partnerships.

Environmental Policy: Committed to protect its employees and the environment at every stage of its business activity, taking special care to design and operate facilities to minimize adverse impact on people and the environment Most organizations focus on products losing patent protection, we have chosen a different path of focusing on smaller, old molecules to make A-Mark in this market. We are equipped to cater to the demand from both pharmerging and advanced countries across the globe for these products, which require cutting-edge R&D, highly flexible manufacturing and a competitive supply chain network

2.3: NEED FOR THE PROJECT: The project falls in the activities listed under the EIA notification, 2006 hence does require prior Environmental Clearance under the EIA notification. However considering nature of the Project, it requires an EIA study for prior appraisal by Karnataka State Pollution Control Board (KSPCB) as part of the project appraisal prior to grant of Consent of Establish permit as well as the report will be used for decision making and implementation mitigation measures and management plan during construction and operation phases of the project. Samarth Life Science is positioned as one of the leading biopharmaceutical developer. Global economic progress and social wellbeing depend a lot on health, both human and animal. Therefore, Samarth life sciences want to help make a difference in these two areas by our ability to compete, innovate and perform. Global pharmaceutical spending is poised to touch US$ 1 trillion by 2017. Their strategies revolve around the changing requirements of our customers and partners, and we comply with evolving standards of regulators. They continue to build on their key capabilities, the realignment has enabled us to enhance focus on key priorities, build their own brand and increase the efficiency of operations. In other words, make tomorrow more promising for customers, partners, investors and the wider community of stakeholders. 9

2.4: DEMAND-SUPPLY GAP:

The biopharmaceuticals industry is a growing sector within the pharmaceuticals industry with immense opportunities and implications for healthcare. success achieved by companies with a few revolutionary new

Entering into long-term manufacturing contracts with CMOs is particularly advantageous for small drug discovery companies. By handing over the responsibility and complexity of daily production to CMOs, these companies are able to minimise their risk considerably.

The global manufacturing capacity of biopharmaceuticals was around 2.27 million litres in 2004. This includes the capacity held by both captive use and contract manufacturers. It is expected to increase to 3.69 million litres in 2011 at a compound annual growth rate (CAGR) of 7.2 per cent. The largest capacity increase is likely to be in 2005 when over 600,000 litres of capacity is expected to be added," notes Mr. Adhikari. "Thereafter, Frost & Sullivan estimates that the addition of new capacity will be slower with single digit growth levels of three to five per cent."

Manufacturing capacity supply is expected to be greater than the worldwide demand throughout 2005-2011. Currently, global demand stands at 1.37 million litres and is likely to increase to 3.13 million litres in 2011. The industry therefore suffers from overcapacity with present utilisation estimated at around 60 per cent. This is expected to increase to 70 per cent by the end of 2006 and 80 per cent in 2008, after which demand is likely to continue rising due to certain key drug approval.

2.5: EXPORT AND IMPORT MARKETS: Export Shipments

HS Code Description India Port Foreign Quantit Country y

30041004 Sion Sr No A 412 Formulation Bombay Air Hong Kong 50000 Valodex (Tamoxifen Citrate

30041090 Obocil 100 Mg Ampicillin Bombay Sea Manila 89200 Sodium For Inje Ction Bp 100

10

Import Shipments HS Code Description India Port Foreign Quantity Country

30041004 Sion Sr No A 412 Formulation Bombay Air Hong Kong 50000 Valodex (Tamoxifen Citrate

2.6: EMPLOYMENT GENERATION (DIRECT AND INDIRECT) DUE TO THE PROJECT: During the construction phase, workers strength of 100 labours will be deployd depending on the construction phase. These people will largely be based in local areas within reachable limits and not likely to impact either the social fabric or create additional pressures on the local resources of nearby villages. The project will therefore provide temporary employment to many families and will result into minor positive impact due to the proposed activity. During production phase the total number of employees to be present will be around 390 members.

11

CHAPTER – 3

PROJECT DESCRIPTION

This chapter encompasses the details of the proposed project, material and resource requirement for existing and for proposed operation phases, utilities, sources of waste generation, estimation of pollution loads and associated infrastructures etc.

3.1 TYPE OF PROJECT The project site is located at Plot no.191-A, KIADB Industrial area 1st stage, Vasanthanarasapura, Kora Hobli, Tumkur tq. and dist. - 572128. Brief description about location, Village, and project area is mentioned in table 2.1.

Sl. No. Item Details 1 Name & address of the Industry Samarth Life sciences Pvt. Ltd., (Location of the Industry) Plot no.191-A, KIADB Industrial area 1st stage, Vasanthanarasapura, KoraHobli, Tumkurtq. and dist.- 572128

2 Village, Taluk,District Vasanthanarasapura, Tumkur tq & District 3 District Tumkur 4 State Karnataka 5 Whether there is any litigationpending None against the project and/or land in which the project ispropose to be set up? (a) Name of the Court (b) Case No. (c) Orders/ directions ofthe Court, if any and itsrelevance with theproposed project

The proposed manufacturing unit to produce bulk drugs project for API products. The nature of product in the expansion phase is 3) To manufacture products by rDNA technology 4) To manufacture biological products using solvent extraction

12

at # 191-A,1st Stage, KIADB Industrial Area, Vasanthanarasapura, Tumkur-572128, Karnataka – India.

Samarth Life Sciences Private Limited proposes to produce 12 number of Active Pharmaceutical Ingredients (API’s) products of Therapeutic category and 12 number of all the products will be manufactured on a batch basis per day. The products arecategories in process or therapeutic usage.

The total site area of the proposed project including the existing facility 19523 sq.m

The detailed area details as follows

Total plot area 19523 sq.m

Ground coverage area 1717 sq.m

Existing + expansion 7000 sq.m Phase 2 Open area- parking, paving, roads etc. 5000 sq.m

Landscape area 5800 sq.m

The Expansion phase area details

Nature of the product Construction area Plot area utilization 1. To manufacture 7000 sq.ft of pilot plant (first No change in land area products by rDNA floor of existing block) utilization technology 2. To manufacture 4000 sq.ft of basement floor No change in land area biological products using utilization solvent extraction

The overall facilities proposed under the project broadly consist of the following elements/operations;  Plant and Machinery & Utilities  Production units  Safety and Pollution control facilities associated with the production of the above.  Supporting services such as Boiler and for DG sets utilities

13

3.2 LOCATION OF THE PROJECT

The proposed project is capacity enhancement of existing product and addition of new drug products for API manufacturing. Its modification and expansion of Bulk drugs manufacturing industry is located at Plot no.191-A, KIADB Industrial area 1st stage, Vasanthnarasapura, Kora Hobli, Tumkur tq. and dist. – 572128.

Google Map

14

15

3.3 DETAILS OF ALTERNATE SITES:

Sl. Particulars Details No. 1 Plant site coordinates Latitude : 13.492385, Longitude: 77.026576

2 Plant Site Elevation 900 mtr above MSL

3 Climatic Conditions (IMD, Avg. Annual Max. Temp: 34oC Bengaluru) Avg. Annual Min. Temp: 12oC Annual Avg. rainfall: 1000 mm 2 Land use at the proposed Industrial land developed by KIADB project site

3 Nearest Highway NH-4

4 Nearest Railway Station Tumkur Railway Station 17.4 Km

5 Nearest Airport Kempegowda International Airport – 106 Km

6 Nearest village Vasanthanarasapura – 900 mtr

Thimmarajanahalli -2.2 Km

7 Nearest major city Tumkur 17 Km

9 Nearest water bodies Kaggere Lake – 8.01 Km Hebbaka Reservoir- 8.09 Km 10 Nearest major hill range Devarayanadurga hills – 30.8 Km Shivaganga hills – 42.6 Km 11 Ecologically sensitive zones Devarayanadurga hills – 30.8 Km or Protected areas as per Shivaganga hills – 42.6 Km Wildlife Protection Act, 1972

12 Critically polluted areas as Nil per CPCB Notification

13 Historical and cultural Devarayanadurga Temple – 30.8 Km important places Shivaganga Temple – 42.6 Km

14 Defense installations Nil

16

3.3.1. PROJECT COST

There is an additional project cost as it is a proposed expansion unit. Cost of the project for expansion and modification is Rs. 20 Crores. The details are listed in the table below

3.4. PROJECT DESCRIPTION

The proposed project is capacity enhancement of existing product and addition of new drug products for API manufacturing. Modification and expansion of manufacturing unit of Bulk drugs is located at Plot no.191-A, KIADB Industrial area 1st stage, Vasnathanarasapura, Kora Hobli, Tumkur tq. and dist. – 572128.

3.4.1 COMPLETE PROCESS DETAILS

Proposed Products to be manufactured:

Sl.No Proposed Products TIME FRAME

1 Heparin Sodium Current Year

2 Enoxaparin Sodium Current Year

3 Sodium Hyaluronate Current Year

4 Protamine Sulphate Current Year

5 Heparin Calcium Current Year

6 Dalteparin Sodium 2 years

7 NandroparinSulphate 2 years

8 Somatostatin 2 years

9 Calcitonin 2 years

10 Bivalirudin 5 years

11 Leuprolide 5 years

12 Octreotide 5 years

17

Proposed Manufacturing Output per Year

Sl.No Proposed Products Yearly Out-Put

1) Heparin Sodium 20,000 X 106Units Enoxaparin Sodium 2) 100kg 3) Sodium Hyaluronate 20kg Protamine Sulphate 4) 40kg

5) Heparin Calcium 5000 X 106Units

6) Dalteparin Sodium 20 kgs

7) NandroparinSulphate 20 kgs Somatostatin 8) 1 kg Calcitonin 9) 1 kg

10) Bivalirudin 1 kg 11) Leuprolide 1 kg 12) Octreotide 1 kg

Proposed Number Batches and Batch Size per Year

Batches Sl.No Proposed Products Batch Size per Batch Per Year 1. Heparin Sodium 1000 X 106Units 20 2. Enoxaparin Sodium 10kg 10 3. Sodium Hyaluronate 2kg 10

18

4. Protamine Sulphate 4kg 10 5. Heparin Calcium 500 X 106Units 10 6. Dalteparin Sodium 2 kgs 10 7. NandroparinSulphate 2 kgs 10 8. Somatostatin 0.1 kg 10 9. Calcitonin 0.1 kg 10 10. Bivalirudin 0.1 kg 10 11. Leuprolide 0.1 kg 10 12. Octreotide 0.1 kg 10

EQUIPMENTS LIST

Sl.No EQUIPMENT NAME CAPACITY

1 Reactor 1000 Ltrs 2 Reactor 500 Ltrs 3 Reactor 250 Ltrs 4 Nusche filter - 5 Sparkler filter - 6 Vaccum tray dryer - 7 Bucket centrifuge - 8 Membrane filtration assembly 147 & 293 mm 9 Receiving vessel 50 Ltrs 10 Centrifugal pump 11 Rotary Evoparator 12 Centrifuge 13 HPLC

19

MANUFACTURING FLOW CHARTS

PRODUCT NAME: HEPARIN SODIUM

Glycosaminoglycan

10% solution with water

Precipitation with Methanol &IPA

Centrifugation

Vaccum drying

10% solution with 0.9% Nacl solution

Sterile filtration

Precipitation with Methanol

Acetone wash

Vaccum drying

Powder Milling

Powder sieving Packing 20

MATERIAL BALANCE SHEET PER BATCH

Product: HEPARIN SODIUM

Batch Size:1000 X 106Units

Sl.N Raw Material Consumption Per Batch o Glycosaminoglycan 1 8.5kg Methanol 2 400 Ltrs Isopropyl alcohol 3 200 Ltrs Sodium chloride 4 1 kg Acetone 5 50 Ltrs. Cleaning Solution 6 4 Ltrs.

PROCESS AND WATER BALANCE

Product: HEPARIN SODIUM

Batch Size: 1000 X 106Units

SL PROCESS Time Material Consumption Water Waste Generated No consumption Liquid Solid

01 10% Solution with 240 min 1. Glycosaminoglycan-8.5kg 85 Ltrs - - water

02 Precipitation with 2 days 1. Methanol-200Ltrs methanol and 2. Isopropyl alcohol-200 Ltrs Isopropyl alcohol - 0.5 kg

03 Centrifugation 300 Min - - 485 -

10% solution with 300 min 1. Sodium Chloride – 1 kg 100 ltrs - - 0.9% Sodium 04 chloride

21

05 Sterile Filtration 30 mins - - - -

06 Precipitation with 360mins 1. Methanol-200Ltrs. - 300 ltrs - methanol

07 Wash with acetone 30 Mins 1.Acetone -50 Ltrs. - 50 ltrs -

08 Vaccum Drying 1 day

06 Packing 60 Mins - - - -

07 Washing 300 815 Ltrs - -

Sl No SUMMARY

01 Water Consumption/Batch 1000Ltrs

02 Liquid Waste

a) Aqueous waste a)1000 Ltrs.

b) Spent solvent b) 650 Ltrs.

Total 1650 Ltrs

03 Solid Waste 0.5kg

04 Process Time 4 days

22

MANUFACTURING FLOW CHARTS

PRODUCT NAME: ENOXAPARIN SODIUM

Heparin/Glycosaminoglycan

10% solution with water

Precipitation with Methanol &IPA

Centrifugation

Vaccum drying

10% solution with 0.9% Nacl solution

Sterile filtration

Precipitation with Methanol

Acetone wash

Vaccum drying

Powder Milling

Powder sieving Packing 23

MATERIAL BALANCE SHEET PER BATCH

Product: ENOXAPARIN SODIUM

Batch Size: 10 kg

Sl.N Raw Material Consumption Per Batch o Glycosaminoglycan/Heparin 1 20 kg Methanol 2 400 Ltrs Isopropyl alcohol 3 200 Ltrs Sodium chloride 4 2 kg Acetone 5 50 Ltrs. Cleaning Solution 6 4 Ltrs.

7 Methylene dichloride 400 ltrs

PROCESS AND WATER BALANCE PER BATCH

Product: ENOXAPARIN SODIUM

Batch Size: 10 kg

SL PROCESS Time Material Consumption Water Waste No consumption Generated

Liquid Solid

01 10% Solution with 240 min 1. Heparin/Glycosaminoglycan- 200Ltrs - - water 20 kg

02 Precipitation with MDC-400 ltrs 600 ltrs MDC

10% solution with 300 min 1. Sodium Chloride – 2 kg 200 ltrs - - 0.9% Sodium 04 chloride

24

02 Precipitation with 2 days 1. Methanol-200Ltrs methanol and 2. Isopropyl alcohol-200 Ltrs Isopropyl alcohol - 600 0.5 kg

03 Centrifugation 300 Min - - - -

10% solution with 300 min 2. Sodium Chloride – 2 kg 200 ltrs - - 0.9% Sodium 04 chloride

05 Filtration 30 mins - - - -

06 Precipitation with 360mins 1. Methanol-200Ltrs. - 400 - methanol

07 Wash with acetone 30 Mins 1.Acetone -50 Ltrs. - 50 -

06 Packing 60 Mins - - - -

07 Washing 300 - 500 Ltrs 500 lts -

Sl No SUMMARY

01 Water Consumption/Batch 1100 Ltrs

02 Liquid Waste

a) Aqueous waste a)1100 Ltrs.

b) Spent solvent b) 1050 Ltrs.

Total 2150 Ltrs.

03 Solid Waste 0.5kg

04 Process Time 4days

25

MANUFACTURING FLOW CHARTS

PRODUCT NAME: PROTAMINE SULPHATE

Peptidoglycans

10% solution with water

Precipitation with Methanol &IPA

Centrifugation

Vaccum drying

10% solution with 0.9% Nacl solution

Sterile filtration

Precipitation with Methanol

Acetone wash

Vaccum drying

Powder Milling

Powder sieving Packing 26

MATERIAL BALANCE SHEET PER BATCH

Product: PROTAMINE SULPHATE

Batch Size: 4 kg

Sl.N Raw Material Consumption Per Batch o Peptidoglycans 1 5 Kg Methanol 2 150 Ltrs Isopropyl alcohol 3 50 Ltrs Sodium chloride 4 500 grms. Acetone 5 50 Ltrs. Cleaning Solution 6 4 Ltrs.

PROCESS AND WATER BALANCE

Product: PROTAMINE SULPHATE

Batch Size: 4 kg

SL PROCESS Time Material Consumption Water Waste Generated No consumption Liquid Solid

01 10% Solution with 240 min 1. Peptidoglycans-5 kg 50 Ltrs - - water

02 Precipitation with 2 days 1. Methanol-50Ltrs methanol and 2. Isopropyl alcohol-50 Ltrs Isopropyl alcohol - 150 0.5 kg

03 Centrifugation 300 Min - - - -

27

10% solution with 300 min 1. Sodium Chloride – 0.5 kg 50 ltrs - - 0.9% Sodium chloride 04

05 Sterile Filtration 30 mins - - - -

06 Precipitation with 360mins 1. Methanol-100Ltrs. - 150 - methanol

07 Wash with acetone 30 Mins 1.Acetone -50 Ltrs. - - -

06 Packing 60 Mins - - - -

07 Washing 300 1% Cleaning Solution 500 Ltrs - -

Sl No SUMMARY

01 Water Consumption/Batch 600 Ltrs

02 Liquid Waste

a) Aqueous waste a)600 Ltrs.

b) Spent solvent b) 250 Ltrs.

Total 850 Ltrs.

03 Solid Waste 0.5 kgs

04 Process Time 4days

28

MANUFACTURING FLOW CHARTS

PRODUCT NAME: SODIUM HYALURONATE

Mucopolysaccharide

10% solution with water

Precipitation with Methanol &IPA

Centrifugation

Vaccum drying

10% solution with 0.9% Nacl solution

Sterile filtration

Precipitation with Methanol

Acetone wash

Vaccum drying

Powder Milling

Powder sieving Packing

29

MATERIAL BALANCE SHEET PER BATCH

Product: SODIUM HYALURONATE

Batch Size: 2.0 kg

Sl.N Raw Material Consumption Per Batch o Glycosaminoglycan 1 2.5 Methanol 2 100Ltrs Isopropyl alcohol 3 50 Ltrs Sodium chloride 4 250 grms. Acetone 5 25 Ltrs. Cleaning Solution 6 4 Ltrs.

PROCESS AND WATER BALANCE

Product: SODIUM HYALURONATE

BATCH -2 kg

SL PROCESS Time Material Consumption Water Waste No consumption Generated

Liquid Solid

01 10% Solution with 240 min 1. Glycosaminoglycan-2.5 kg 25 Ltrs - - water

02 Precipitation with 2 days 1. Methanol-50 Ltrs methanol and 2. Isopropyl alcohol-50 Ltrs Isopropyl alcohol - 125 0.2 kg

30

03 Centrifugation 300 Min - - - -

10% solution with 300 min 1. Sodium Chloride – 250 gm 25 - - 0.9% Sodium 04 chloride

05 Sterile Filtration 30 mins - - - -

06 Precipitation with 360mins 1. Methanol-50Ltrs. - 75 - methanol

07 Wash with acetone 30 Mins 1.Acetone -25 Ltrs. - 25 -

06 Packing 60 Mins - - - -

07 Washing 300 - 500 Ltrs 500 -

Sl No SUMMARY

01 Water Consumption/Batch 550Ltrs

02 Liquid Waste

a) Aqueous waste a)550 Ltrs.

b) Spent solvent b) 175 Ltrs.

Total 725 ltrs

03 Solid Waste 0.2 kg

04 Process Time 4days

31

MANUFACTURING FLOW CHARTS

PRODUCT NAME: HEPARIN CALCIUM

Glycosaminoglycan

10% solution with water

Precipitation with Methanol &IPA

Centrifugation

Vaccum drying

10% solution with 0.9% Nacl solution

Sterile filtration

Precipitation with Methanol

Acetone wash

Vaccum drying

Powder Milling

Packing Powder sieving 32

MATERIAL BALANCE SHEET PER BATCH

Product: HEPARIN CACLIUM

Batch Size: 500 X 106Units

Sl.N Raw Material Consumption Per Batch o Glycosaminoglycan 1 4.25 kg Methanol 2 200 Ltrs Isopropyl alcohol 3 100 Ltrs Calcium chloride 4 0.5 kg Acetone 5 25 Ltrs. Cleaning Solution 6 4 Ltrs.

PROCESS AND WATER BALANCE PER BATCH

Product: HEPARIN CACLIUM Batch Size: 500 X 106Units

SL PROCESS Time Material Consumption Water Waste Generated No consumption Liquid Solid

01 10% Solution with 240 min 2. Glycosaminoglycan- 4.25 kg 42.5Ltrs - - water

02 Precipitation with 2 days 3. Methanol-100Ltrs methanol and 4. Isopropyl alcohol-100 Ltrs Isopropyl alcohol - 0.5 kg

03 Centrifugation 300 Min - - 242.5 -

33

10% solution with 300 min 2. Calcium chloride – 0.5 kg 50 ltrs - - 0.9% Sodium 04 chloride

05 Sterile Filtration 30 mins - - - -

06 Precipitation with 360mins 2. Methanol-100Ltrs. - 150 ltrs - methanol

07 Wash with acetone 30 Mins 1.Acetone -25Ltrs. - 25ltrs -

08 Vaccum Drying 1 day

Packing 60 - - - -

06 Mins

07 Washing 300 - 300 -

Sl No SUMMARY

01 Water Consumption/Batch 382.5Ltrs

02 Liquid Waste

a) Aqueous waste a)382.5Ltrs.

b) Spent solvent b) 418.5Ltrs.

Total 800Ltrs

03 Solid Waste 0.5kg

04 Process Time 4 days

34

MANUFACTURING FLOW CHARTS

PRODUCT NAME: DALTEPARIN SODIUM

Heparin/Glycosaminoglycan

10% solution with water

Precipitation with Methanol &IPA

Centrifugation

Vaccum drying

10% solution with 0.9% Nacl solution

Sterile filtration

Precipitation with Methanol

Acetone wash

Vaccum drying

Powder Milling

Packing Powder sieving 35

MATERIAL BALANCE SHEET PER BATCH

Product: DALTEPARIN SODIUM

Batch Size: 2 kg

Sl.N Raw Material Consumption Per Batch o Glycosaminoglycan/Heparin 1 4 kg Methanol 2 80 Ltrs Isopropyl alcohol 3 40Ltrs Sodium chloride 4 0.8kg Acetone 5 10 Ltrs. Cleaning Solution 6 4 Ltrs.

7 Methylene dichloride 80 ltrs

PROCESS AND WATER BALANCE

Product: DALTEPARIN SODIUM

Batch Size: 2 kg

SL PROCESS Time Material Consumption Water Waste No consumption Generated

Liquid Solid

01 10% Solution with 240 min 2. Heparin/Glycosaminoglycan-4 40Ltrs - - water kg

02 Precipitation with MDC-80ltrs 120ltrs

36

MDC

10% solution with 300 min 3. Sodium Chloride – 400 g 40ltrs - - 0.9% Sodium 04 chloride

02 Precipitation with 2 days 3. Methanol-40Ltrs methanol and 4. Isopropyl alcohol-40Ltrs Isopropyl alcohol - 120 0.5 kg

03 Centrifugation 300 Min - - - -

10% solution with 300 min 4. Sodium Chloride – 400g 40ltrs - - 0.9% Sodium 04 chloride

05 Filtration 30 mins - - - -

06 Precipitation with 360mins 2. Methanol-40Ltrs. - 80 - methanol

07 Wash with acetone 30 Mins 1.Acetone -12.5Ltrs. - 12.5 -

06 Packing 60 Mins - - - -

07 Washing 300 - 500 Ltrs 500 lts -

Sl No SUMMARY

01 Water Consumption/Batch 620Ltrs

02 Liquid Waste

a) Aqueous waste a)620Ltrs.

b) Spent solvent b) 212.5Ltrs.

Total 832.5Ltrs.

03 Solid Waste 0.5kg

04 Process Time 4days

37

MANUFACTURING FLOW CHARTS

PRODUCT NAME: NANDROPARIN SULPHATE

Heparin/Glycosaminoglycan

10% solution with water

Precipitation with Methanol &IPA

Centrifugation

Vaccum drying

10% solution with 1%H2SO4 solution

Sterile filtration

Precipitation with Methanol

Acetone wash

Vaccum drying

Powder Milling

Powder sieving Packing 38

MATERIAL BALANCE SHEET PER BATCH

Product: NANDROPARIN SULPHATE

Batch Size: 2 kg

Sl.N Raw Material Consumption Per Batch o Glycosaminoglycan/Heparin 1 4 kg Methanol 2 80 Ltrs Isopropyl alcohol 3 40 Ltrs H SO 4 2 4 0.4kg Acetone 5 10 Ltrs. Cleaning Solution 6 4 Ltrs.

7 Methylene dichloride 80 ltrs

39

PROCESS AND WATER BALANCE

Product: NANDROPARIN SULPHATE

Batch Size: 2 kg

SL PROCESS Time Material Consumption Water Waste Generated No consumption Liquid Solid

01 10% Solution with 240 min 3. Heparin/Glycosaminoglycan-4 40Ltrs - - water kg

02 Precipitation with MDC-80ltrs 120 ltrs MDC

10% solution with 300 min 5. 1% H2SO4 – 200 ml 40 ltrs - - 0.9% Sodium 04 chloride

02 Precipitation with 2 days 5. Methanol-40Ltrs methanol and 6. Isopropyl alcohol-40 Ltrs Isopropyl alcohol - 120 0.5 kg

03 Centrifugation 300 Min - - - -

10% solution with 300 min 1. 1% H2SO4 – 200 ml 40 ltrs - - 0.9% Sodium 04 chloride

05 Filtration 30 mins - - - -

06 Precipitation with 360mins 3. Methanol-40Ltrs. - 80 - methanol

07 Wash with acetone 30 Mins 1.Acetone -12.5 Ltrs. - 12.5 -

06 Packing 60Mins - - - -

07 Washing 300 - 550 Ltrs 550 lts -

40

Sl No SUMMARY

01 Water Consumption/Batch 670 Ltrs

02 Liquid Waste

a) Aqueous waste a)650 Ltrs.

b) Spent solvent b) 212.5Ltrs.

Total 882.5Ltrs.

03 Solid Waste 0.5kg

04 Process Time 4days

41

MANUFACTURING FLOW CHARTS

PRODUCT NAME: SOMATOSTATIN

Batch size: 100g

Synthetic mixture of peptides with > 60% Somatostatin Dissolution

Acid treatment Trifluroacetic acid

Cooling of solution

Water Addition of water with stirring

Keep solution at 2-8°C

Acetone Extraction Aqueous Phase

Sodium phosphate mono and dibasic, acetic acid, methanol, Chromatography Washings chloroform Concentration Acetone Redisollution Water

Freeze drying

42

MATERIAL BALANCE SHEET PER BATCH

Product: SOMATOSTATIN

Batch Size: 100 g

Sl.N Raw Material Consumption Per Batch o 60% somatostatin 1 250 grams Trifluroacetic acid 2 500 ml Acetone 3 20Ltrs Cleaning Solution 6 4 Ltrs.

7 Sodium phosphate mono and dibasic 250g

8 Methanol 2L

9 Chloroform 2L

10 Acetic acid 500ml

PROCESS AND WATER BALANCE PER BATCH

Product: SOMATOSTATIN Batch Size: 100g

SL PROCESS Time Material Consumption Water Waste Generated No consumption Liquid Solid

01 Dissolution 60 min 1. >60 % Somatostatin 250 g 2ltrs - -

02 Acid Treatment 90 min 1.Trifluroacetic acid -500 ml -

- -

03 Cool the Solution 120 min - - - -

43

04 Addition of water 60 min - 1 lt - -

05 Keep the solution @ 600 mim - - - -

2- 8oC

06 Extraction 300 min 1. Acetone – 10 ltrs - - -

07 Centrifugation 120 min - 13 ltrs 150g

08 Chromatograghy 300 min 1.Sodium Phosphate mono basic and Dibasic – 250 g 40 ltrs 2.Methanol – 2l 39 ltrs - 3.Chloroform – 2l

4.Acetic acid – 500 ml

09 Concentration 300 min Acetone 10 Ltrs 11 ltrs

10 Redissolution 30 min 1 ltr

11 Freeze drying 1440 min 1 ltr

12 Washing 240 min 200 200

Sl No SUMMARY

01 Water Consumption/Batch 244 Ltrs

02 Liquid Waste

a) Aqueous waste a) 244 Ltrs.

b) Spent solvent b) 20 Ltrs.

Total 264Ltrs

03 Solid Waste 0.150kg

04 Process Time 2.5 days

44

MANUFACTURING FLOW CHARTS

PRODUCT NAME: CALCITONIN

Batch size: 100g

Synthetic mixture of peptides Dissolution with > 60% Calcitonin

Acid treatment Trifluroacetic acid

Cooling of solution

Water Addition of water with stirring

Keep solution↓ at 2-8°C Acetone

Extraction Sodium phosphate mono and ↓ Aqueous phase dibasic, acetic acid, methanol, Chromatography chloroform Washings

Acetone Concentration

Water Redisollution

Freeze drying

45

MATERIAL BALANCE SHEET PER BATCH

Product: CALCITONIN

Batch Size: 100 g

Sl.N Raw Material Consumption Per Batch o 60% Calcitonin 1 250 grams Trifluroacetic acid 2 500 ml Acetone 3 20Ltrs Cleaning Solution 6 4 Ltrs.

7 Sodium phosphate mono and dibasic 250g

8 Methanol 2L

9 Chloroform 2L

10 Acetic acid 500ml

PROCESS AND WATER BALANCE PER BATCH

Product: CALCITONIN Batch Size: 100g

SL PROCESS Time Material Consumption Water Waste No consumption Generated

Liquid Solid

01 Dissolution 60 min 1. >60 % Calcitonin 250 g 2ltrs - -

02 Acid Treatment 90 min 1.Trifluroacetic acid -500 ml - - -

03 Cool the Solution 120 min - - - -

04 Addition of water 60 min - 1 lt - -

46

05 Keep the solution @ 600 mim - - - -

2- 8oC

06 Extraction 300 min 1. Acetone – 10 ltrs - - -

07 Centrifugation 120 min - 13 ltrs 150g

08 Chromatograghy 300 min 1.Sodium Phosphate mono basic and Dibasic – 250 g 40 ltrs 2.Methanol – 2l 39 ltrs - 3.Chloroform – 2l

4.Acetic acid – 500 ml

09 Concentration 300 min Acetone 10 Ltrs 11 ltrs

10 Redissolution 30 min 1 ltr

11 Freeze drying 1440 min 1 ltr

12 Washing 240 min 200 200

Sl No SUMMARY

01 Water Consumption/Batch 244 Ltrs

02 Liquid Waste

a) Aqueous waste a) 244 Ltrs.

b) Spent solvent b) 20 Ltrs.

Total 264 Ltrs

03 Solid Waste 0.150kg

04 Process Time 2.5 days

47

MANUFACTURING FLOW CHARTS

PRODUCT NAME : BIVALIRUDIN

Batch size: 100g

Synthetic mixture of peptides Dissolution with > 60% Bivalirudin

Trifluroacetic acid Acid treatment

Cooling of solution

Water Addition of water with stirring

Keep solution at 2-8°C

Acetone Extraction Sodium phosphate mono and Aqueous Phase dibasic, acetic acid, methanol, Chromatography chloroform Washings Acetone Concentration

Water Redisollution

Freeze drying

48

MATERIAL BALANCE SHEET PER BATCH

Product: BIVALIRUDIN

Batch Size: 100 g

Sl.N Raw Material Consumption Per Batch o 60% Bivalirudin 1 250 grams Trifluroacetic acid 2 500 ml Acetone 3 20Ltrs Cleaning Solution 6 4 Ltrs.

7 Sodium phosphate mono and dibasic 250g

8 Methanol 2L

9 Chloroform 2L

10 Acetic acid 500ml

PROCESS AND WATER BALANCE PER BATCH

Product: BIVALIRUDIN Batch Size: 100g

SL PROCESS Time Material Consumption Water Waste Generated No consumption Liquid Solid

01 Dissolution 60 min 1. >60 % Bivalirudin 250 g 2ltrs - -

02 Acid Treatment 90 min 1.Trifluroacetic acid -500 ml -

- -

49

03 Cool the Solution 120 min - - - -

04 Addition of water 60 min - 1 lt - -

05 Keep the solution @ 600 mim - - - -

2- 8oC

06 Extraction 300 min 1. Acetone – 10 ltrs - - -

07 Centrifugation 120 min - 13 ltrs 150g

08 Chromatograghy 300 min 1.Sodium Phosphate mono basic and Dibasic – 250 g 40 ltrs 2.Methanol – 2l 39 ltrs - 3.Chloroform – 2l

4.Acetic acid – 500 ml

300 min Acetone 10 Ltrs 11 ltrs

09 Concentration

10 Redissolution 30 min 1 ltr

11 Freeze drying 1440 min 1 ltr

12 Washing 240min 200 200

Sl No SUMMARY

01 Water Consumption/Batch 244 Ltrs

02 Liquid Waste

a) Aqueous waste a) 244 Ltrs.

b) Spent solvent b) 20 Ltrs.

Total 264 Ltrs

50

03 Solid Waste 0.150kg

04 Process Time 2.5 days

MANUFACTURING FLOW CHARTS

PRODUCT NAME: LEUPROLIDE

Batch size: 100g

Synthetic mixture of peptides Dissolution with > 60% Leuprolide

Trifluroacetic acid Acid treatment

Cooling of solution

Water Addition of water with stirring

Keep solution at 2-8°C

Acetone Extraction Aqueous phase Sodium phosphate mono and Chromatography dibasic, acetic acid, methanol, Washings chloroform Concentration Acetone Water Redisollution

Freeze drying

51

MATERIAL BALANCE SHEET PER BATCH

Product: LEUPROLIDE

Batch Size: 100 g

Sl.N Raw Material Consumption Per Batch o 60% Leuprolide 1 250 grams Trifluroacetic acid 2 500 ml Acetone 3 20Ltrs Cleaning Solution 6 4 Ltrs.

7 Sodium phosphate mono and dibasic 250g

8 Methanol 2L

9 Chloroform 2L

10 Acetic acid 500ml

PROCESS AND WATER BALANCE PER BATCH

Product: LEUPROLIDE Batch Size: 100g

SL PROCESS Time Material Consumption Water Waste Generated No consumption Liquid Solid

01 Dissolution 60 min 1. >60 % Leuprolide 250 g 2ltrs - -

02 Acid Treatment 90 min 1.Trifluroacetic acid -500 ml - - -

03 Cool the Solution 120 min - - - -

04 Addition of water 60 min - 1 lt - -

05 Keep the solution @ 600 mim - - - - 2- 8oC

52

06 Extraction 300 min 1. Acetone – 10 ltrs - - -

07 Centrifugation 120 min - 13 ltrs 150g

08 Chromatograghy 300 min 1.Sodium Phosphate mono basic and Dibasic – 250 g 40 ltrs 2.Methanol – 2l 39 ltrs - 3.Chloroform – 2l

4.Acetic acid – 500 ml

09 Concentration 300 min Acetone 10 Ltrs 11 ltrs

10 Redissolution 30 min 1 ltr

11 Freeze drying 1440 min 1 ltr

12 Washing 240 min 250 250

Sl No SUMMARY

01 Water Consumption/Batch 294Ltrs

02 Liquid Waste

a) Aqueous waste a) 294 Ltrs.

b) Spent solvent b) 20 Ltrs.

Total 314Ltrs

03 Solid Waste 0.150kg

04 Process Time 2.5 days

53

MANUFACTURING FLOW CHARTS

PRODUCT NAME: OCTREOTIDE

Batch size: 100g

Synthetic mixture of peptides Dissolution with > 60% Octreotide

Trifluroacetic acid Acid treatment

Cooling of solution

Water Addition of water with stirring

Keep solution at 2-8°C

Acetone Extraction Aqueous phase Sodium phosphate mono and dibasic, acetic acid, methanol, Chromatography Washings chloroform Concentration Acetone

Water Redisollution

Freeze drying

54

MATERIAL BALANCE SHEET PER BATCH

Product: OCTREOTIDE

Batch Size: 100 g

Sl.N Raw Material Consumption Per Batch o 60% Octreotide 1 250 grams Trifluroacetic acid 2 500 ml Acetone 3 20Ltrs Cleaning Solution 6 4 Ltrs.

7 Sodium phosphate mono and dibasic 250g

8 Methanol 2L

9 Chloroform 2L

10 Acetic acid 500ml

PROCESS AND WATER BALANCE PER BATCH

Product: OCTREOTIDE Batch Size: 100g

SL PROCESS Time Material Consumption Water Waste No consumption Generated

Liquid Solid

01 Dissolution 60 min 1. >60 % Octreotide 250 g 2ltrs - -

02 Acid Treatment 90 min 1.Trifluroacetic acid -500 ml - - -

03 Cool the Solution 120 min - - - -

04 Addition of water 60 min - 1 lt - -

55

05 Keep the solution @ 600 mim - - - - 2- 8oC 06 Extraction 300 min 1. Acetone – 10 ltrs - - -

07 Centrifugation 120 min - 13 ltrs 150g

08 Chromatograghy 300 min 1.Sodium Phosphate mono basic and Dibasic – 250 g 40 ltrs 2.Methanol – 2l 39 ltrs - 3.Chloroform – 2l

4.Acetic acid – 500 ml

09 Concentration 300 min Acetone 10 Ltrs 11 ltrs

10 Redissolution 30 min 1 ltr

11 Freeze drying 1440 min 1 ltr

12 Washing 240 min 200 200

Sl No SUMMARY

01 Water Consumption/Batch 244 Ltrs

02 Liquid Waste

a) Aqueous waste a) 244 Ltrs.

b) Spent solvent b) 20 Ltrs.

Total 264 Ltrs

03 Solid Waste 0.150kg

04 Process Time 2.5 days

56

Proposed Products to be manufactured in Recombinant Block: Time Frame – 2 years Mammalian Cell Culture Based Product

Sl.No Proposed Products TIME FRAME

1 Recombinant Human Chorionic Gonadotrophin Current Year

2 Recombinant Human Follicle Stimulating Current Year Hormone

3 Recombinant Human Luteinizing Hormone Current Year

4 Recombinant Human Factor VIII Current Year

5 Recombinant Human Erythropoietin Current Year

6 Rituximab (Monoclonal Antibody) Current Year

7 Trastuzumab 2 years

8 Cetuximab 2 years

9 Bevacizumab 2 years

10 Panitumumab 2 years

11 Itolizumab 5 years

12 Nimotuzumab 5 years

57

Bacterial Cell Culture Based Products

TIME Sl.No Proposed Products FRAME

1 Recombinant tissue plasminogen activator(Alteplase) Current Year

2 Interferon α-2 2 years

3 Recombinantgranulocyte macrophage colony 2 years stimulating factor (GMCSF)

Yeast Culture Based Products

Sl.No Proposed Products TIME FRAME

1 Recombinant human Insulin 2 years

2 Recombinant human albumin 2 years

3 Recombinant somatropin 2 years

Proposed Manufacturing Output per Year

Sl.No Proposed Products Yearly Out-Put

6 1 Recombinant Human Chorionic Gonadotrophin 5000 X 10 Units

2 Recombinant Human Follicle Stimulating Hormone 25 X 106Units

58

3 Recombinant Human Luteinizing Hormone 25 X106Units

Recombinant Human Factor VIII 4 50 X 106Units

5 Recombinant Human Erythropoietin 25 X 106Units 6 Rituximab (Monoclonal Antibody) 5 kgs 7 Trastuzumab 6 kgs 8 Cetuximab 5 kgs 9 Bevacizumab 5 kgs 10 Panitumumab 5 kgs 11 Itolizumab 500 g 12 Nimotuzumab 1.0 kg 13 Erythropoietin alpha 200 X106Units 14 Recombinant tissue plasminogen activator(Alteplase) 10 kgs 15 Interferon α-2 10,000 X 106Units Recombinantgranulocyte macrophage colony stimulating 16 1500 X 106Units factor (GMCSF) 17 Recombinant human Insulin 50 X 106Units 18 Recombinant human albumin 40 kgs 19 Recombinant somatropin 400 gms

Proposed Number Batches and Batch Size per Year

Batch Size Batches Sl.No Proposed Products per Batch Per Year

6 1 Recombinant Human Chorionic Gonadotrophin 500 X 10 Units 10 2 Recombinant Human Follicle Stimulating Hormone 2.5 X 106Units 10 3 Recombinant Human Luteinizing Hormone 2.5 X106Units 10 4 Recombinant Human Factor VIII 5.0 X 106Units 10 5 Recombinant Human Erythropoietin 2.5 X 106Units 10 6 Rituximab (Monoclonal Antibody) 0.5 kgs 10 7 Trastuzumab 0.6 kgs 10 8 Cetuximab 0.5 kgs 10 9 Bevacizumab 0.5 kgs 10 10 Panitumumab 0.5 kgs 10 11 Itolizumab 50 g 10 12 Nimotuzumab 100 g 10 13 Erythropoietin alpha 20 X106Units 10 14 Recombinant tissue plasminogen 1.0 kgs 10 59

activator(Alteplase) Interferon α-2 15 1000 X 106Units 10

Recombinantgranulocyte macrophage colony 16 150 X 106Units 10 stimulating factor (GMCSF) 17 Recombinant human Insulin 5.0 X 106Units 10

LIST OF RAW MATERIALS

Required for manufacturing of the Proposed Products per Year

Sl.No. Materials Quantity 1 Activated Charcoal 1.0 kg 2 Hydrochloric acid 200Ltrs. 3 Potassium Phosphate Monobasic 30 Kgs. 4 Potassium Phosphate dibasic 30 Kgs. 5 Antifoam Agent 200Ltrs. 7 Sodium chloride 50Kgs. 8 Sodium Phosphate Monobasic 60 Kgs. 9 Sodium Phosphate dibasic 60 Kgs. 10 Sodium Hydroxide 330Kgs. 11 CHO medium 1130kgs 12 Yeast Medium 330 kgs 13 Chromatography Resins 300Ltrs. 14 Cleaning Solution 500Ltrs. 15 Bacterial Medium 330 kgs

* Note: Chromatographic resins will be reused.

EQUIPMENTS LIST

Sl.No Equipment Name 1 Chromatography Columns 2 Ultrafiltration System 3 Centrifuge (Refrigerated) 4 Tubular Centrifuge 5 pH Meter 6 Conductivity Meter

60

7 UV-Vis Spectrophotometer 8 Head Top- Stirrer 9 Magnetic Stirrer 10 Nitrogen Filtration set-up 11 DM Water Plant 12 Autoclave 13 Dry Heat Sterilizer 14 Cold Room 15 Vacuum Oven 16 Lyophiliser 17 Laminar Air Flow 18 SS Pressure Vessel – 5 Ltrs 19 SS Pressure Vessel – 25 Ltrs 20 SS Pressure vessel – 50 Ltrs 21 SS Receiving Vessel – 5 Ltrs 22 SS Receiving Vessel – 25 Ltrs 23 SS Receiving vessel – 50 Ltrs 24 Vacuum pump – ½ HP 25 ELISA Reader 26 Refrigerator (Horizontal) 27 Deep Freezer (Horizontal) 28 Bioreactor

61

MANUFACTURING FLOW CHARTS

PRODUCT NAME:RECOMBINANT HUMAN CHORIONIC GONADOTROPHIN

Seed Culture CHO Media Preparation

BIOREACTOR

(FERMANTATION)

Centrifugation

Filtration

Tangential Flow Filtration 1 ( TFF / UF)

Chromatography 1

Tangential Flow Filtration &

Dia filtration 2

Chromatography 2

Tangential Flow Filtration &

Diafiltration 3

Chromatography 3

Tangential Flow Filtration &

Dia filtration 4

Formulation & Filtration

Lyophilization

62

MATERIAL BALANCE SHEET PER BATCH

Product: Recombinant Human Chorionic Gonadotrophin Batch Size: 500 X106 Units

Sl.No Raw Material Consumption Per Batch

1 Hydrochloric Acid 1 Ltrs.

2 Activated Charcoal 5 gms

3 Potassium Phosphate Monobasic 100 grms.

4 Potassium Phosphate Dibasic 100 grms.

5 Sodium Phosphate Monobasic 200 grms.

6 Sodium Phosphate Dibasic 200 grms.

7 Sodium Chloride 3 Kgs.

8 CHO medium 11 kgs

9 Antifoam agent 1 Ltrs.

11 Sodium Hydroxide 1.780 Kgs.

12 Chromatography resin* 30 Ltrs.

* Note: Chromatographic resins will be reused.

63

Product: Recombinant Human Chorionic Gonadotrophin PROCESS AND WATER BALANCE PER BATCH -500 X 106 Units SL PROCESS Time Material Consumption Water Waste Generated No consumption Liquid Solid 01 Seed Culture - Inoculum CHO medium -1 kg 10 ltrs

02 Media Preparation 120 min CHO Medium – 10 kg 100 ltrs

03 Bioreactor/ 8 days Sodium Hydroxide – 1 kg Fermentation Hydrochloric acid – 1 ltr Antifoam - 1ltr

Centrifugation 300 04 min 1 kg

05 Filtration 60 mins

06 Tangential Flow 300 Sodium Hydroxide- 120 g 50 ltrs 150 ltrs Filtration -1 mins Sodium Hydroxide -100g 07 Chromatography -1 300 Potassium phosphate Mins monobasic - 100g Potassium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 1 kg Chromatography resin-10ltrs

06 Tangential Flow 300 Sodium Hydroxide- 120 g 50 ltrs 50 ltrs Filtration -2 & mins Diafiltration Sodium Hydroxide -100g 07 Chromatography -2 300 Sodium phosphate Mins monobasic - 100g Sodium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 1 kg Chromatography resin-10ltrs

8 Tangential Flow 300 Sodium Hydroxide- 120 g 50 ltrs 50 ltrs Filtration -3 & mins Diafiltration Sodium Hydroxide -100g 64

09 Chromatography -3 300 Sodium phosphate Mins monobasic - 100g Sodium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 1 kg Chromatography resin-10ltrs

10 Tangential Flow 300 1.Sodium Hydroxide- 120 g 100 ltrs 100ltrs Filtration -4 & mins Diafiltration 11 Formulation & 60 Filtration Mins 12 Lyophilization 3 days 5 ltrs 13 Packing 60 Mins 14 Cleaning 300 1% Cleaning Solution 1000 ltrs 1000 Ltrs

Sl No SUMMARY 01 Water Consumption/Batch 1660Ltrs 02 Liquid Waste 1655ltrs 03 Solid Waste 1 kg 04 Process Time 13 days

65

MANUFACTURING FLOW CHARTS PRODUCT NAME: RECOMBINANT HUMANFOLLICLE STIMULATING HORMONE

Seed Culture CHO Media Preparation

BIOREACTOR (FERMANTATION)

Centrifugation

Filtration

Tangential Flow Filtration

1 ( TFF / UF)

Chromatography 1

Tangential Flow Filtration & Dia filtration 2

Chromatography 2

Tangential Flow Filtration &

Diafiltration 3

Chromatography 3

Tangential Flow Filtration &

Dia filtration 4

Formulation & Filtration

Lyophilization

66

MATERIAL BALANCE SHEET PER BATCH

Product: Recombinant Human Follicle Stimulating Hormo Batch Size: 2.5 X 106 Units

Sl.No Raw Material Consumption Per Batch 1 Hydrochloric Acid 1.0Ltrs.

2 Activated Charcoal 5 grms.

3 Potassium Phosphate Monobasic 100 grms.

4 Potassium Phosphate Dibasic 100 grms.

5 Sodium Phosphate Monobasic 200 grms.

6 Sodium Phosphate Dibasic 200 grms.

7 Sodium Chloride 3.6Kgs.

8 CHO medium 11.0 kgs

9 Antifoam agent 1.0Ltrs.

11 Sodium Hydroxide 1.82 Kgs.

12 Chromatography resin* 30 Ltrs.

* Note: Chromatographic resins will be reused.

67

PRODUCT NAME: RECOMBINANT HUMAN FOLLICLE STIMULATING HORMONE

PROCESS AND WATER BALANCE PER BATCH -2.5 X106 Units

SL PROCESS Time Material Consumption Water Waste Generated No consumption Liquid Solid 01 Seed Culture - Inoculum CHO medium -1.0 ltrs 10ltrs

02 Media Preparation 120 min CHO Medium – 10.0 ltrs 100 ltrs

03 Bioreactor/ 8 days Sodium Hydroxide – 1 kg Fermentation Hydrochloric acid – 1 ltr Antifoam - 1ltr

Centrifugation 300 04 min 1 kg

05 Filtration 60 mins

06 Tangential Flow 300 Sodium Hydroxide- 130 g 50 ltrs 150ltrs Filtration -1 mins Sodium Hydroxide -100g 07 Chromatography -1 300 Potassium phosphate Mins monobasic - 100g Potassium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 1.2 kg Chromatography resin-10ltrs

06 Tangential Flow 300 Sodium Hydroxide- 130 g 50 ltrs 50 ltrs Filtration -2 & mins Diafiltration 1.Sodium Hydroxide -100g 07 Chromatography -2 300 2.Sodium phosphate Mins monobasic - 100g 3.Sodium phosphate 100 ltrs 100ltrs dibasic - 100 g 4.Sodium Chloride – 1.2 kg 5.Chromatography resin-10ltrs

68

Cont…

08 Tangential Flow 300 Sodium Hydroxide- 130 g 50 ltrs 50 ltrs Filtration -3 & mins Diafiltration Sodium Hydroxide -100g 09 Chromatography -3 300 Sodium phosphate Mins monobasic - 100g Sodium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 1.2 kg Chromatography resin-10ltrs

10 Tangential Flow 300 Sodium Hydroxide- 130 g 100 ltrs 100ltrs Filtration -4 & mins Diafiltration 11 Formulation & 60 Filtration Mins 12 Lyophilization 3 days 5 ltrs 13 Packing 60 Mins 14 Cleaning 300 1% Cleaning agent 1200 ltrs 1200 Ltrs

Sl No SUMMARY

01 Water Consumption/Batch 1860Ltrs

02 Liquid Waste 1855ltrs

03 Solid Waste 1 kg

04 Process Time 13 days

69

MANUFACTURING FLOW CHARTS

PRODUCT NAME: RECOMBINANT HUMAN LUTEINIZING HORMONE

Seed Culture CHO Media Preparation BIOREACTOR

(FERMANTATION)

Centrifugation

Filtration

Tangential Flow Filtration

1 ( TFF / UF)

Chromatography 1

Tangential Flow Filtration & Dia filtration 2

Chromatography 2

Tangential Flow Filtration & Diafiltration 3

Chromatography 3

Tangential Flow Filtration &

Diafiltration 4

Formulation & Filtration

Lyophilization

Lyophilization

70

MATERIAL BALANCE SHEET PER BATCH Product: Recombinant HumanLuteinizing Hormone Batch Size: 2.5 X 106 Units

Sl.No Raw Material Consumption Per Batch 1 Hydrochloric Acid 1.0 Ltrs.

2 Activated Charcoal 5 gms

3 Potassium Phosphate Monobasic 100 grms.

4 Potassium Phosphate Dibasic 100 grms.

5 Sodium Phosphate Monobasic 200 grms.

6 Sodium Phosphate Dibasic 200 grms.

7 Sodium Chloride 2.4Kgs.

8 CHO medium 11.0 kgs.

9 Antifoam agent 1.0Ltrs.

11 Sodium Hydroxide 1.70Kgs.

12 Chromatography resin* 30 Ltrs.

* Note: Chromatographic resins will be reused.

71

PRODUCT NAME: RECOMBINANT LEUTINIZING HORMONE

PROCESS AND WATER BALANCE PER BATCH -2.5 X 106 Units

SL PROCESS Time Material Consumption Water Waste Generated No consumption Liquid Solid 01 Seed Culture - Inoculum CHO medium -1.0 kgs 10 ltrs

02 Media Preparation 120 min CHO Medium – 10.0 kgs 100 ltrs

03 Bioreactor/ 8 days Sodium Hydroxide – 1 kg Fermentation Hydrochloric acid – 1 ltr Antifoam - 1ltr

Centrifugation 300 04 min 1 kg

05 Filtration 60 min

06 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 150 ltrs Filtration -1 min Sodium Hydroxide -100g 07 Chromatography -1 300 Potassium phosphate Mins monobasic - 100g Potassium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 0.8 kg Chromatography resin-10ltrs

06 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 50 ltrs Filtration -2 & mins Diafiltration Sodium Hydroxide -100g 07 Chromatography -2 300 Sodium phosphate Mins monobasic - 100g Sodium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 0.8 kg Chromatography resin-10ltrs

72

Cont…

08 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 50 ltrs Filtration -3 & mins Diafiltration Sodium Hydroxide -100g 09 Chromatography -3 300 Sodium phosphate Mins monobasic - 100g Sodium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 0.8 kg Chromatography resin-10ltrs

10 Tangential Flow 300 Sodium Hydroxide- 100 g 100 ltrs 100ltrs Filtration -4 & mins Diafiltration 11 Formulation & 60 Filtration Mins 12 Lyophilization 3 days 5 ltrs 13 Packing 60 Mins 14 Cleaning 300 1% Cleaning Solution 1100 ltrs 1100Ltrs

Sl No SUMMARY

01 Water Consumption/Batch 1760 Ltrs

02 Liquid Waste 1755 ltrs

03 Solid Waste 1 kg

04 Process Time 13 days

73

MANUFACTURING FLOW CHARTS

PRODUCT NAME: Recombinant Human Factor VIII

Seed Culture CHO Media Preparation BIOREACTOR

(FERMANTATION)

Centrifugation

Filtration

Tangential Flow Filtration

1 ( TFF / UF)

Chromatography 1

Tangential Flow Filtration & Dia filtration 2

Chromatography 2

Tangential Flow Filtration & Diafiltration 3

Chromatography 3

Tangential Flow Filtration &

Diafiltration 4

Formulation & Filtration

Lyophilization

Lyophilization

74

MATERIAL BALANCE SHEET PER BATCH Product: Recombinant Human Factor VIII Batch Size: 5.0 X106 Units

Sl.No Raw Material Consumption Per Batch 1 Hydrochloric Acid 1.0 Ltrs.

2 Activated Charcoal 5 gms

3 Potassium Phosphate Monobasic 100 grms.

4 Potassium Phosphate Dibasic 100 grms.

5 Sodium Phosphate Monobasic 200 grms.

6 Sodium Phosphate Dibasic 200 grms.

7 Sodium Chloride 2.4 Kgs.

8 CHO medium 11.0 kgs.

9 Antifoam agent 1.0Ltrs.

10 Water 1650 ltrs

11 Sodium Hydroxide 1.70Kgs.

12 Chromatography resin* 30 Ltrs.

* Note: Chromatographic resins will be reused

75

PRODUCT NAME: Recombinant Human Factor VIII PROCESS AND WATER BALANCE PER BATCH -5.0 X 106 Units

SL PROCESS Time Material Consumption Water Waste Generated No consumption Liquid Solid 01 Seed Culture - 1.Inoculum 2.CHO medium -1.0 kgs 10 ltrs

02 Media Preparation 120 min 1.CHO Medium – 10.0 kgs 100 ltrs

03 Bioreactor/ 8 days 1. Sodium Hydroxide – 1 kg Fermentation Hydrochloric acid – 1 ltr Antifoam - 1ltr

Centrifugation 300 04 min 1 kg

05 Filtration 60 min

06 Tangential Flow 300 1. Sodium Hydroxide- 100 g 50 ltrs 150ltrs Filtration -1 min 1 Sodium Hydroxide -100g 07 Chromatography -1 300 2 Potassium phosphate Mins monobasic - 100g 3 Potassium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 0.8 kg Chromatography resin-10ltrs

06 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 50 ltrs Filtration -2 & mins Diafiltration Sodium Hydroxide -100g 07 Chromatography -2 300 Sodium phosphate Mins monobasic - 100g Sodium phosphate 100 ltrs 100 ltrs dibasic - 100 g Sodium Chloride – 0.8 kg Chromatography resin-10ltrs

76

Cont…

08 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 50 ltrs Filtration -3 & mins Diafiltration Sodium Hydroxide -100g 09 Chromatography -3 300 Sodium phosphate Mins monobasic - 100g Sodium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 0.8 kg Chromatography resin-10ltrs

10 Tangential Flow 300 1.Sodium Hydroxide- 100 g 100 ltrs 100ltrs Filtration -4 & mins Diafiltration 11 Formulation & 60 Filtration Mins 12 Lyophilization 3 days 5 ltrs 13 Packing 60 Mins 14 Cleaning 300 1% Cleaning Solution 1100 ltrs 1100 Ltrs

Sl No SUMMARY

01 Water Consumption/Batch 1660 Ltrs

02 Liquid Waste 1655 ltrs

03 Solid Waste 1 kg

04 Process Time 13 days

77

MANUFACTURING FLOW CHARTS

PRODUCT NAME: Recombinant Human Erythropoietin

Seed Culture CHO Media Preparation BIOREACTOR

(FERMANTATION)

Centrifugation

Filtration

Tangential Flow Filtration

1 ( TFF / UF)

Chromatography 1

Tangential Flow Filtration & Dia filtration 2

Chromatography 2

Tangential Flow Filtration & Diafiltration 3

Chromatography 3

Tangential Flow Filtration &

Diafiltration 4

Formulation & Filtration

Lyophilization

78

MATERIAL BALANCE SHEET PER BATCH Product: Recombinant Human Erythropoietin Batch Size: 2.5 X 106 Units

Sl.No Raw Material Consumption Per Batch 1 Hydrochloric Acid 1.0 Ltrs.

2 Activated Charcoal 5 gms

3 Potassium Phosphate Monobasic 100 grms.

4 Potassium Phosphate Dibasic 100 grms.

5 Sodium Phosphate Monobasic 200 grms.

6 Sodium Phosphate Dibasic 200 grms.

7 Sodium Chloride 2.4 Kgs.

8 CHO medium 11.0 kgs.

9 Antifoam agent 1.0Ltrs.

11 Sodium Hydroxide 1.70Kgs.

12 Chromatography resin* 30 Ltrs.

* Note: Chromatographic resins will be reused.

79

PRODUCT NAME: Recombinant Human Erythropoietin PROCESS AND WATER BALANCE PER BATCH -2.5 X 106 Units

SL PROCESS Time Material Consumption Water Waste Generated No consumption Liquid Solid 01 Seed Culture - Inoculum CHO medium -1.0 ltrs 10 ltrs

02 Media Preparation 120 mins CHO Medium – 10.0 kgs 100 ltrs

03 Bioreactor/ 8 days Sodium Hydroxide – 1 kg Fermentation Hydrochloric acid – 1 ltr Antifoam - 1ltr

Centrifugation 300 04 min 1 kg

05 Filtration 60 min

06 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 150ltrs Filtration -1 min Sodium Hydroxide -100g 07 Chromatography -1 300 Potassium phosphate Mins monobasic - 100g Potassium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 0.8 kg Chromatography resin-10ltrs

06 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 50 ltrs Filtration -2 & mins Diafiltration 1.Sodium Hydroxide -100g 07 Chromatography -2 300 Sodium phosphate Mins monobasic - 100g Sodium phosphate 100 ltrs 100 ltrs dibasic - 100 g Sodium Chloride – 0.8kg Chromatography resin-10ltrs

80

Cont…

08 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 50 ltrs Filtration -3 & mins Diafiltration Sodium Hydroxide -100g 09 Chromatography -3 300 Sodium phosphate Mins monobasic - 100g Sodium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 0.8 kg Chromatography resin-10ltrs

10 Tangential Flow 300 Sodium Hydroxide- 100 g 100 ltrs 100ltrs Filtration -4 & mins Diafiltration 11 Formulation & 60 Filtration Mins 12 Lyophilization 3 days 5 ltrs 13 Packing 60 Mins 14 Cleaning 300 1% Cleaning Solution 1100 ltrs 1100 Ltrs

Sl No SUMMARY

01 Water Consumption/Batch 1760Ltrs

02 Liquid Waste 1755ltrs

03 Solid Waste 1 kg

04 Process Time 13 days

81

MANUFACTURING FLOW CHARTS

PRODUCT NAME: Rituximab

Seed Culture CHO Media Preparation BIOREACTOR

(FERMANTATION)

Centrifugation

Filtration

Tangential Flow Filtration

1 ( TFF / UF)

Chromatography 1

Tangential Flow Filtration & Dia filtration 2

Chromatography 2

Tangential Flow Filtration & Diafiltration 3

Chromatography 3

Tangential Flow Filtration &

Diafiltration 4

Formulation & Filtration

Lyophilization

82

MATERIAL BALANCE SHEET PER BATCH Product: Rituximab Batch Size: 0.5 KG

Sl.No Raw Material Consumption Per Batch 1 Hydrochloric Acid 1.0 Ltrs.

2 Activated Charcoal 5 gms

3 Potassium Phosphate Monobasic 100 grms.

4 Potassium Phosphate Dibasic 100 grms.

5 Sodium Phosphate Monobasic 200 grms.

6 Sodium Phosphate Dibasic 200 grms.

7 Sodium Chloride 2.4 Kgs.

8 CHO medium 11.0 kgs.

9 Antifoam agent 1.0Ltrs.

10 Water 1650 ltrs

11 Sodium Hydroxide 1.70Kgs.

12 Chromatography resin* 30 Ltrs.

* Note: Chromatographic resins will be reused

83

PRODUCT NAME: Rituximab PROCESS AND WATER BALANCE PER BATCH - 0.5 KG

SL PROCESS Time Material Consumption Water Waste Generated No consumption Liquid Solid 01 Seed Culture - Inoculum CHO medium -1.0kgs 10 ltrs

02 Media Preparation n CHO Medium – 10.0 kgs 100 ltrs

03 Bioreactor/ 8 days Sodium Hydroxide – 1 kg Fermentation Hydrochloric acid – 1 ltr Antifoam - 1ltr

Centrifugation 300 04 min 1 kg

05 Filtration 60 min

06 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 150 ltrs Filtration -1 min 1.Sodium Hydroxide -100g 07 Chromatography -1 300 2.Potassium phosphate Mins monobasic - 100g 3.Potassium phosphate 100 ltrs 100ltrs dibasic - 100 g 4.Sodium Chloride – 0.8 kg 5.Chromatography resin-10ltrs

06 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 150 ltrs Filtration -2 & mins Diafiltration Sodium Hydroxide -100g 07 Chromatography -2 300 Sodium phosphate Mins monobasic - 100g Sodium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 0.8 kg Chromatography resin-10ltrs

84

Cont…

08 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 50 ltrs Filtration -3 & mins Diafiltration Sodium Hydroxide -100g 09 Chromatography -3 300 Sodium phosphate Mins monobasic - 100g Sodium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 0.8 kg Chromatography resin-10ltrs

10 Tangential Flow 300 Sodium Hydroxide- 100 g 100 ltrs 95 ltrs Filtration -4 & mins Diafiltration 11 Formulation & 60 Filtration Mins 12 Lyophilization 3 days 5 ltrs 13 Packing 60 Mins 14 Cleaning 300 1% Cleaning Solution 1050 ltrs 1050Ltrs

Sl No SUMMARY

01 Water Consumption/Batch 1710Ltrs

02 Liquid Waste 1705ltrs

03 Solid Waste 1 kg

04 Process Time 13 days

85

MANUFACTURING FLOW CHARTS

PRODUCT NAME: Trastuzumab

Seed Culture CHO Media Preparation BIOREACTOR

(FERMANTATION)

Centrifugation

Filtration

Tangential Flow Filtration

1 ( TFF / UF)

Chromatography 1

Tangential Flow Filtration & Dia filtration 2

Chromatography 2

Tangential Flow Filtration & Diafiltration 3

Chromatography 3

Tangential Flow Filtration &

Diafiltration 4

Formulation & Filtration

Lyophilization

86

MATERIAL BALANCE SHEET PER BATCH Product: Trastuzumab Batch Size: 0.6 KG

Sl.No Raw Material Consumption Per Batch 1 Hydrochloric Acid 1.0 Ltrs.

2 Activated Charcoal 5 gms

3 Potassium Phosphate Monobasic 100 grms.

4 Potassium Phosphate Dibasic 100 grms.

5 Sodium Phosphate Monobasic 200 grms.

6 Sodium Phosphate Dibasic 200 grms.

7 Sodium Chloride 2.4 Kgs.

8 CHO medium 11.0 kgs.

9 Antifoam agent 1.0Ltrs.

10 Sodium Hydroxide 1.70Kgs.

11 Chromatography resin* 30 Ltrs.

* Note: Chromatographic resins will be reused.

87

PRODUCT NAME: Trastuzumab PROCESS AND WATER BALANCE PER BATCH - 0.6 KG

SL PROCESS Time Material Consumption Water Waste Generated No consumption Liquid Solid 01 Seed Culture - Inoculum CHO medium -1.0 kgs 10 ltrs

02 Media Preparation n CHO Medium – 10.0 kgs 100 ltrs

03 Bioreactor/ days Sodium Hydroxide – 1 kg Fermentation Hydrochloric acid – 1 ltr Antifoam - 1ltr

Centrifugation 300 04 min 1 kg

05 Filtration 60 min

06 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 150ltrs Filtration -1 min Sodium Hydroxide -100g 07 Chromatography -1 300 1.Potassium phosphate Mins monobasic - 100g 2.Potassium phosphate 100 ltrs 100ltrs dibasic - 100 g 3.Sodium Chloride – 0.8 kg 4.Chromatography resin-10ltrs

06 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 50 ltrs Filtration -2 & mins Diafiltration Sodium Hydroxide -100g 07 Chromatography -2 300 Sodium phosphate Mins monobasic - 100g Sodium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 0.8 kg Chromatography resin-10ltrs

88

Cont…

08 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 50 ltrs Filtration -3 & mins Diafiltration Sodium Hydroxide -100g 09 Chromatography -3 300 Sodium phosphate Mins monobasic - 100g Sodium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 0.8 kg Chromatography resin-10ltrs

10 Tangential Flow 300 Sodium Hydroxide- 100 g 100 ltrs 100ltrs Filtration -4 & mins Diafiltration 11 Formulation & 60 Filtration Mins 12 Lyophilization 3 days 5 ltrs 13 Packing 60 Mins 14 Cleaning 300 1% Cleaning Solution 1200 ltrs 1200 Ltrs

Sl No SUMMARY

01 Water Consumption/Batch 1860 Ltrs

02 Liquid Waste 1855 ltrs

03 Solid Waste 1 kg

04 Process Time 13 days

89

MANUFACTURING FLOW CHARTS

PRODUCT NAME: Cetuximab

Seed Culture CHO Media Preparation BIOREACTOR

(FERMANTATION)

Centrifugation

Filtration

Tangential Flow Filtration

1 ( TFF / UF)

Chromatography 1

Tangential Flow Filtration & Dia filtration 2

Chromatography 2

Tangential Flow Filtration & Diafiltration 3

Chromatography 3

Tangential Flow Filtration &

Diafiltration 4

Formulation & Filtration

Lyophilization

90

MATERIAL BALANCE SHEET PER BATCH Product: Cetuximab Batch Size: 0.5 KG

Sl.No Raw Material Consumption Per Batch 1 Hydrochloric Acid 1.0 Ltrs.

2 Activated Charcoal 5 gms

3 Potassium Phosphate Monobasic 100 grms.

4 Potassium Phosphate Dibasic 100 grms.

5 Sodium Phosphate Monobasic 200 grms.

6 Sodium Phosphate Dibasic 200 grms.

7 Sodium Chloride 2.4 Kgs.

8 CHO medium 11.0 kgs

9 Antifoam agent 1.0Ltrs.

10 Sodium Hydroxide 1.70Kgs.

11 Chromatography resin* 30 Ltrs.

* Note: Chromatographic resins will be reused.

91

PRODUCT NAME: Cetuximab PROCESS AND WATER BALANCE PER BATCH - 0.5 KG

SL PROCESS Time Material Consumption Water Waste Generated No consumption Liquid Solid 01 Seed Culture - Inoculum CHO medium -1.0 kgs 10 ltrs

02 Media Preparation 120 mins CHO Medium – 10.0 kgs 100 ltrs

03 Bioreactor/ 8 days 1.Sodium Hydroxide – 1 kg Fermentation 2.Hydrochloric acid – 1 ltr 3.Antifoam - 1ltr

Centrifugation 300 04 min 1 kg

05 Filtration 60 min

06 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 150ltrs Filtration -1 min Sodium Hydroxide -100g 07 Chromatography -1 300 Potassium phosphate Mins monobasic - 100g Potassium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 0.8 kg Chromatography resin-10ltrs

06 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 50 ltrs Filtration -2 & mins Diafiltration Sodium Hydroxide -100g 07 Chromatography -2 300 Sodium phosphate Mins monobasic - 100g Sodium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 0.8 kg Chromatography resin-10ltrs

92

Cont…

08 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 50 ltrs Filtration -3 & mins Diafiltration 1.Sodium Hydroxide -100g 09 Chromatography -3 300 2.Sodium phosphate Mins monobasic - 100g 3.Sodium phosphate 100 ltrs 100ltrs dibasic - 100 g 4.Sodium Chloride – 0.8 kg 5.Chromatography resin-10ltrs

10 Tangential Flow 300 Sodium Hydroxide- 100 g 100 ltrs 100ltrs Filtration -4 & mins Diafiltration 11 Formulation & 60 Filtration Mins 12 Lyophilization 3 days 5 ltrs 13 Packing 60 Mins 14 Cleaning 300 1% Cleaning Solution 1100 ltrs 1100 Ltrs

Sl No SUMMARY

01 Water Consumption/Batch 1760Ltrs

02 Liquid Waste 1755ltrs

03 Solid Waste 1 kg

04 Process Time 13 days

93

MANUFACTURING FLOW CHARTS

PRODUCT NAME: Bevacizumab

Seed Culture CHO Media Preparation BIOREACTOR

(FERMANTATION)

Centrifugation

Filtration

Tangential Flow Filtration

1 ( TFF / UF)

Chromatography 1

Tangential Flow Filtration & Dia filtration 2

Chromatography 2

Tangential Flow Filtration & Diafiltration 3

Chromatography 3

Tangential Flow Filtration &

Diafiltration 4

Formulation & Filtration

Lyophilization

94

MATERIAL BALANCE SHEET PER BATCH Product: Bevacizumab Batch Size: 0.5 KG

Sl.No Raw Material Consumption Per Batch 1 Hydrochloric Acid 1.0 Ltrs.

2 Activated Charcoal 5 gms

3 Potassium Phosphate Monobasic 100 grms.

4 Potassium Phosphate Dibasic 100 grms.

5 Sodium Phosphate Monobasic 200 grms.

6 Sodium Phosphate Dibasic 200 grms.

7 Sodium Chloride 2.4 Kgs.

8 CHO medium 11.0 kgs.

9 Antifoam agent 1.0Ltrs.

10 Sodium Hydroxide 1.70Kgs.

11 Chromatography resin* 30 Ltrs.

* Note: Chromatographic resins will be reused.

95

PRODUCT NAME: Bevacizumab PROCESS AND WATER BALANCE PER BATCH - 0.5 KG

SL PROCESS Time Material Consumption Water Waste Generated No consumption Liquid Solid 01 Seed Culture - Inoculum 2 .CHO medium -1.0 kg 10 ltrs

02 Media Preparation 120 mins CHO Medium – 10 kgs 100 ltrs

03 Bioreactor/ 8 days Sodium Hydroxide – 1 kg Fermentation Hydrochloric acid – 1 ltr Antifoam - 1ltr

Centrifugation 300 04 min 1 kg

05 Filtration 60 min

06 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 150ltrs Filtration -1 min Sodium Hydroxide -100g 07 Chromatography -1 300 Potassium phosphate Mins monobasic - 100g Potassium phosphate 100 ltrs 100 ltrs dibasic - 100 g Sodium Chloride – 0.8 kg Chromatography resin-10ltrs

06 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 50 ltrs Filtration -2 & mins Diafiltration Sodium Hydroxide -100g 07 Chromatography -2 300 Sodium phosphate Mins monobasic - 100g Sodium phosphate 100 ltrs 100 ltrs dibasic - 100 g Sodium Chloride – 0.8 kg Chromatography resin-10ltrs

96

Cont…

08 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 50 ltrs Filtration -3 & mins Diafiltration 1.Sodium Hydroxide -100g 09 Chromatography -3 300 2.Sodium phosphate Mins monobasic - 100g 3.Sodium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 0.8 kg Chromatography resin-10ltrs

10 Tangential Flow 300 Sodium Hydroxide- 100 g 100 ltrs 100ltrs Filtration -4 & mins Diafiltration 11 Formulation & 60 Filtration Mins 12 Lyophilization 3 days 5 ltrs 13 Packing 60 Mins 14 Cleaning 300 1% Cleaning Solution 1200 ltrs 1200 Ltrs

Sl No SUMMARY

01 Water Consumption/Batch 1860 Ltrs

02 Liquid Waste 1855 ltrs

03 Solid Waste 1 kg

04 Process Time 13 days

97

MANUFACTURING FLOW CHARTS

PRODUCT NAME: Panitumumab

Seed Culture CHO Media Preparation BIOREACTOR

(FERMANTATION)

Centrifugation

Filtration

Tangential Flow Filtration

1 ( TFF / UF)

Chromatography 1

Tangential Flow Filtration & Dia filtration 2

Chromatography 2

Tangential Flow Filtration & Diafiltration 3

Chromatography 3

Tangential Flow Filtration &

Diafiltration 4

Formulation & Filtration

Lyophilization

98

MATERIAL BALANCE SHEET PER BATCH Product: Panitumumab Batch Size: 0.5 KG

Sl.No Raw Material Consumption Per Batch 1 Hydrochloric Acid 1.0 Ltrs.

2 Activated Charcoal 5 gms

3 Potassium Phosphate Monobasic 100 grms.

4 Potassium Phosphate Dibasic 100 grms.

5 Sodium Phosphate Monobasic 200 grms.

6 Sodium Phosphate Dibasic 200 grms.

7 Sodium Chloride 2.4 Kgs.

8 CHO medium 11.0 kgs

9 Antifoam agent 1.0Ltrs.

10 Sodium Hydroxide 1.70Kgs.

11 Chromatography resin* 30 Ltrs.

* Note: Chromatographic resins will be reused.

99

PRODUCT NAME: Panitumumab PROCESS AND WATER BALANCE PER BATCH - 0.5 KG

SL PROCESS Time Material Consumption Water Waste Generated No consumption Liquid Solid 01 Seed Culture Inoculum CHO medium -1.0 kg 10 ltrs

02 Media Preparation 120 mins 1.CHO Medium – 10.0 kgs 100 ltrs

03 Bioreactor/ days 1.Sodium Hydroxide – 1 kg Fermentation 2.Hydrochloric acid – 1 ltr 3.Antifoam - 1ltr

Centrifugation 300 04 min 1 kg

05 Filtration 60 min

06 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 150 ltrs Filtration -1 min Sodium Hydroxide -100g 07 Chromatography -1 300 Potassium phosphate Mins monobasic - 100g Potassium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 0.8 kg Chromatography resin-10ltrs

06 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 50 ltrs Filtration -2 & mins Diafiltration 1.Sodium Hydroxide -100g 07 Chromatography -2 300 2.Sodium phosphate Mins monobasic - 100g 3.Sodium phosphate 100 ltrs 100ltrs dibasic - 100 g 4.Sodium Chloride – 0.8 kg 5.Chromatography resin-10ltrs

100

Cont…

08 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 50 ltrs Filtration -3 & mins Diafiltration 1.Sodium Hydroxide -100g 09 Chromatography -3 300 1.Sodium phosphate Mins monobasic - 100g 2.Sodium phosphate 100 ltrs 100ltrs dibasic - 100 g 3.Sodium Chloride – 0.8 kg 4.Chromatography resin-10ltrs

10 Tangential Flow 300 Sodium Hydroxide- 100 g 100 ltrs 100ltrs Filtration -4 & mins Diafiltration 11 Formulation & 60 Filtration Mins 12 Lyophilization 3 days 5 ltrs 13 Packing 60 Mins 14 Cleaning 300 1% Cleaning Solution 1200 ltrs 1200 Ltrs

Sl No SUMMARY

01 Water Consumption/Batch 1860 Ltrs

02 Liquid Waste 1855 ltrs

03 Solid Waste 1 kg

04 Process Time 13 days

101

MANUFACTURING FLOW CHARTS

PRODUCT NAME: Itolizumab

Seed Culture CHO Media Preparation BIOREACTOR

(FERMANTATION)

Centrifugation

Filtration

Tangential Flow Filtration

1 ( TFF / UF)

Chromatography 1

Tangential Flow Filtration & Dia filtration 2

Chromatography 2

Tangential Flow Filtration & Diafiltration 3

Chromatography 3

Tangential Flow Filtration &

Diafiltration 4

Formulation & Filtration

Lyophilization

Lyophilization

102

MATERIAL BALANCE SHEET PER BATCH Product: Itolizumab Batch Size: 50 gms

Sl. No Raw Material Consumption Per Batch 1 Hydrochloric Acid 1.0 Ltrs.

2 Activated Charcoal 5 gms

3 Potassium Phosphate Monobasic 100 grms.

4 Potassium Phosphate Dibasic 100 grms.

5 Sodium Phosphate Monobasic 200 grms.

6 Sodium Phosphate Dibasic 200 grms.

7 Sodium Chloride 2.4 Kgs.

8 CHO medium 11.0 kgs.

9 Antifoam agent 1.0Ltrs.

10 Sodium Hydroxide 1.70Kgs.

11 Chromatography resin* 30 Ltrs.

* Note: Chromatographic resins will be reused.

103

PRODUCT NAME: Itolizumab PROCESS AND WATER BALANCE PER BATCH – 50 gms

SL PROCESS Time Material Consumption Water Waste Generated No consumption Liquid Solid 01 Seed Culture - Inoculum CHO medium -1.0 kg 10 ltrs

02 Media Preparation 120 mins CHO Medium – 10.0 kgs 100 ltrs

03 Bioreactor/ 8 days Sodium Hydroxide – 1 kg Fermentation Hydrochloric acid – 1 ltr Antifoam - 1ltr

Centrifugation 300 04 min 1 kg

05 Filtration 60 min

06 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 150ltrs Filtration -1 min Sodium Hydroxide -100g 07 Chromatography -1 300 Potassium phosphate Mins monobasic - 100g Potassium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 0.8 kg Chromatography resin-10ltrs

06 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 50 ltrs Filtration -2 & mins Diafiltration Sodium Hydroxide -100g 07 Chromatography -2 300 Sodium phosphate Mins monobasic - 100g Sodium phosphate 100 ltrs 100 ltrs dibasic - 100 g Sodium Chloride – 0.8 kg Chromatography resin-10ltrs

104

Cont…

08 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 50 ltrs Filtration -3 & mins Diafiltration Sodium Hydroxide -100g 09 Chromatography -3 300 Sodium phosphate Mins monobasic - 100g Sodium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 0.8 kg Chromatography resin-10ltrs

10 Tangential Flow 300 Sodium Hydroxide- 100 g 100 ltrs 100 ltrs Filtration -4 & mins Diafiltration 11 Formulation & 60 Filtration Mins 12 Lyophilization 3 days 5 ltrs 13 Packing 60 Mins 14 Cleaning 300 1% Cleaning Solution 1000 ltrs 1000 Ltrs

Sl No SUMMARY

01 Water Consumption/Batch 1660 Ltrs

02 Liquid Waste 1655 ltrs

03 Solid Waste 1 kg

04 Process Time 13 days

105

MANUFACTURING FLOW CHARTS

PRODUCT NAME: Nimotuzumab

Seed Culture CHO Media Preparation BIOREACTOR

(FERMANTATION)

Centrifugation

Filtration

Tangential Flow Filtration

1 ( TFF / UF)

Chromatography 1

Tangential Flow Filtration & Dia filtration 2

Chromatography 2

Tangential Flow Filtration & Diafiltration 3

Chromatography 3

Tangential Flow Filtration &

Diafiltration 4

Formulation & Filtration

Lyophilization

106

MATERIAL BALANCE SHEET PER BATCH Product: Nimotuzumab Batch Size: 100 gms

Sl.No Raw Material Consumption Per Batch 1 Hydrochloric Acid 1.0 Ltrs.

2 Activated Charcoal 5 gms

3 Potassium Phosphate Monobasic 100 grms.

4 Potassium Phosphate Dibasic 100 grms.

5 Sodium Phosphate Monobasic 200 grms.

6 Sodium Phosphate Dibasic 200 grms.

7 Sodium Chloride 2.4 Kgs.

8 CHO medium 11.0 Ltrs.

9 Antifoam agent 1.0Ltrs.

10 Sodium Hydroxide 1.70Kgs.

11 Chromatography resin* 30 Ltrs.

* Note: Chromatographic resins will be reused.

107

PRODUCT NAME: Nimotuzumab PROCESS AND WATER BALANCE PER BATCH – 100gms

SL PROCESS Time Material Consumption Water Waste Generated No consumption Liquid Solid 01 Seed Culture Inoculum 10 ltrs CHO medium -10 ltrs

02 Media Preparation 120 mins CHO Medium – 100 ltrs 100 ltrs

03 Bioreactor/ days Sodium Hydroxide – 1 kg Fermentation Hydrochloric acid – 1 ltr Antifoam - 1ltr

Centrifugation 300 04 Min 1 kg

05 Filtration 60 min

06 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 150ltrs Filtration -1 min Sodium Hydroxide -100g 07 Chromatography -1 300 Potassium phosphate Mins monobasic - 100g Potassium phosphate 100 ltrs 100 ltrs dibasic - 100 g Sodium Chloride – 0.8 kg Chromatography resin-10ltrs

06 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 50 ltrs Filtration -2 & mins Diafiltration 1.Sodium Hydroxide -100g 07 Chromatography -2 300 2.Sodium phosphate Mins monobasic - 100g 3.Sodium phosphate 100 ltrs 100 ltrs dibasic - 100 g Sodium Chloride – 0.8kg Chromatography resin-10ltrs

108

Cont…

08 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 50 ltrs Filtration -3 & mins Diafiltration Sodium Hydroxide -100g 09 Chromatography -3 300 Sodium phosphate Mins monobasic - 100g Sodium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 0.8 kg Chromatography resin-10ltrs

10 Tangential Flow 300 1.Sodium Hydroxide- 100 g 100 ltrs 100 ltrs Filtration -4 & mins Diafiltration 11 Formulation & 60 Filtration Mins 12 Lyophilization 3 days 5 ltrs 13 Packing 60 Mins 14 Cleaning 300 1% Cleaning Solution 1050 ltrs 1050 Ltrs

Sl No SUMMARY

01 Water Consumption/Batch 1710Ltrs

02 Liquid Waste 1705ltrs

03 Solid Waste 1 kg

04 Process Time 13 days

109

MANUFACTURING FLOW CHARTS

PRODUCT NAME: Recombinant tissue plasminogen activator

Seed Culture Bacterial Media BIOREACTOR Preparation

(FERMANTATION)

Centrifugation

Filtration

Tangential Flow Filtration

1 ( TFF / UF)

Chromatography 1

Tangential Flow Filtration & Dia filtration 2

Chromatography 2

Tangential Flow Filtration & Diafiltration 3

Chromatography 3

Tangential Flow Filtration &

Diafiltration 4

Formulation & Filtration

Lyophilization

110

MATERIAL BALANCE SHEET PER BATCH Product: Recombinant tissue plasminogen activator Batch Size: 1 kg

Sl.No Raw Material Consumption Per Batch 1 Hydrochloric Acid 1.0 Ltrs.

2 Activated Charcoal 5 gms

3 Potassium Phosphate Monobasic 100 grms.

4 Potassium Phosphate Dibasic 100 grms.

5 Sodium Phosphate Monobasic 200 grms.

6 Sodium Phosphate Dibasic 200 grms.

7 Sodium Chloride 2.4 Kgs.

8 Bacterial medium 11.0 Ltrs.

9 Antifoam agent 1.0Ltrs.

10 Sodium Hydroxide 1.70Kgs.

11 Chromatography resin* 30 Ltrs.

* Note: Chromatographic resins will be reused.

111

PRODUCT NAME: Recombinant tissue plasminogen activator PROCESS AND WATER BALANCE PER BATCH – 1 kg

SL PROCESS Time Material Consumption Water Waste Generated No consumption Liquid Solid 01 Seed Culture 2 days 1.Inoculum 2.Bacterial medium -1.0 kgs 10 ltrs

02 Media Preparation n 1.Bacterial Medium – 10.0 kgs 100 ltrs

03 Bioreactor/ days 1.Sodium Hydroxide – 1 kg Fermentation 2.Hydrochloric acid – 1 ltr 3.Antifoam - 1ltr

Centrifugation 300 04 min 1 kg

05 Filtration 60 min

06 Tangential Flow 300 1.Sodium Hydroxide- 100 g 50 ltrs 150ltrs Filtration -1 min Sodium Hydroxide -100g 07 Chromatography -1 300 Potassium phosphate Mins monobasic - 100g Potassium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 0.8 kg Chromatography resin-10ltrs

06 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 50 ltrs Filtration -2 & mins Diafiltration Sodium Hydroxide -100g 07 Chromatography -2 300 Sodium phosphate Mins monobasic - 100g Sodium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 0.8 kg Chromatography resin-10ltrs

112

Cont…

08 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 50 ltrs Filtration -3 & mins Diafiltration Sodium Hydroxide -100g 09 Chromatography -3 300 Sodium phosphate Mins monobasic - 100g Sodium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 0.8 kg Chromatography resin-10ltrs

10 Tangential Flow 300 Sodium Hydroxide- 100 g 100 ltrs 100 ltrs Filtration -4 & mins Diafiltration 11 Formulation & 60 Filtration Mins 12 Lyophilization 3 days 5 ltrs 13 Packing 60 Mins 14 Cleaning 300 1% Cleaning Solution 1000ltrs 1000 Ltrs

Sl No SUMMARY

01 Water Consumption/Batch 1660 Ltrs

02 Liquid Waste 1655 ltrs

03 Solid Waste 1 kg

04 Process Time 7 days

113

MANUFACTURING FLOW CHARTS

PRODUCT NAME: Interferon α-2

Seed Culture Bacterial Media BIOREACTOR Preparation

(FERMANTATION)

Centrifugation

Filtration

Tangential Flow Filtration

1 ( TFF / UF)

Chromatography 1

Tangential Flow Filtration & Dia filtration 2

Chromatography 2

Tangential Flow Filtration & Diafiltration 3

Chromatography 3

Tangential Flow Filtration &

Diafiltration 4

Formulation & Filtration

Lyophilization

114

MATERIAL BALANCE SHEET PER BATCH Product: Interferon α-2 Batch Size: 1000 X 106Units

Sl.No Raw Material Consumption Per Batch 1 Hydrochloric Acid 1.0 Ltrs.

2 Activated Charcoal 5 gms

3 Potassium Phosphate Monobasic 100 grms.

4 Potassium Phosphate Dibasic 100 grms.

5 Sodium Phosphate Monobasic 200 grms.

6 Sodium Phosphate Dibasic 200 grms.

7 Sodium Chloride 2.4 Kgs.

8 Bacterial medium 11.0 kgs

9 Antifoam agent 1.0Ltrs.

10 Sodium Hydroxide 1.70Kgs.

11 Chromatography resin* 30 Ltrs.

* Note: Chromatographic resins will be reused.

115

PRODUCT NAME: Interferon α-2 PROCESS AND WATER BALANCE PER BATCH – 1000 X 106Units

SL PROCESS Time Material Consumption Water Waste Generated No consumption Liquid Solid 01 Seed Culture 2 days 1.Inoculum 2.Bacterial medium -1.0 kgs 10 ltrs

02 Media Preparation 120 mins 1.Bacterial Medium – 10.0 kgs 100 ltrs

03 Bioreactor/ 3 days 1.Sodium Hydroxide – 1 kg Fermentation 2.Hydrochloric acid – 1 ltr 3. Antifoam - 1ltr

Centrifugation 300 04 min 1 kg

05 Filtration 60 min

06 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 150ltrs Filtration -1 min Sodium Hydroxide -100g 07 Chromatography -1 300 Potassium phosphate Mins monobasic - 100g Potassium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 0.8 kg Chromatography resin-10ltrs

06 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 100 ltrs Filtration -2 & mins Diafiltration Sodium Hydroxide -100g 07 Chromatography -2 300 Sodium phosphate Mins monobasic - 100g Sodium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 0.8 kg Chromatography resin-10ltrs

116

Cont…

08 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 50 ltrs Filtration -3 & mins Diafiltration 1.Sodium Hydroxide -100g 09 Chromatography -3 300 2.Sodium phosphate Mins monobasic - 100g 3.Sodium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 0.8 kg Chromatography resin-10ltrs

10 Tangential Flow 300 1.Sodium Hydroxide- 100 g 100 ltrs 100ltrs Filtration -4 & mins Diafiltration 11 Formulation & 60 Filtration Mins 12 Lyophilization 3 days 5 ltrs 13 Packing 60 Mins 14 Cleaning 300 1% Cleaning Solution 1100 ltrs 1100 Ltrs

Sl No SUMMARY

01 Water Consumption/Batch 1760Ltrs

02 Liquid Waste 1755ltrs

03 Solid Waste 1 kg

04 Process Time 7 days

117

MANUFACTURING FLOW CHARTS PRODUCT NAME: Recombinant granulocyte macrophage colony stimulating factor

Seed Culture Bacterial Media BIOREACTOR Preparation

(FERMANTATION)

Centrifugation

Filtration

Tangential Flow Filtration

1 ( TFF / UF)

Chromatography 1

Tangential Flow Filtration & Dia filtration 2

Chromatography 2

Tangential Flow Filtration & Diafiltration 3

Chromatography 3

Tangential Flow Filtration &

Diafiltration 4

Formulation & Filtration

Lyophilization

118

MATERIAL BALANCE SHEET PER BATCH Product: Recombinant granulocyte macrophage colony stimulating factor Batch Size: 150 X 106Units

Sl.No Raw Material Consumption Per Batch 1 Hydrochloric Acid 1.0 Ltrs.

2 Activated Charcoal 5 gms

3 Potassium Phosphate Monobasic 100 grms.

4 Potassium Phosphate Dibasic 100 grms.

5 Sodium Phosphate Monobasic 200 grms.

6 Sodium Phosphate Dibasic 200 grms.

7 Sodium Chloride 2.4 Kgs.

8 Bacterial medium 11.0 kgs

9 Antifoam agent 1.0Ltrs.

10 Sodium Hydroxide 1.70Kgs.

11 Chromatography resin* 30 Ltrs.

* Note: Chromatographic resins will be reused.

119

PRODUCT NAME: Recombinant granulocyte macrophage colony stimulating factor PROCESS AND WATER BALANCE PER BATCH – 150 X 106Units

SL PROCESS Time Material Consumption Water Waste Generated No consumption Liquid Solid 01 Seed Culture 2 days 1.Inoculum 2.Bacterial medium -1.0 kg 10 ltrs

02 Media Preparation 120mins 1.Bacterial Medium – 10.0 kgs 100 ltrs

03 Bioreactor/ 2 days Sodium Hydroxide – 1 kg Fermentation Hydrochloric acid – 1 ltr Antifoam - 1ltr

Centrifugation 300 04 min 1 kg

05 Filtration 60 min

06 Tangential Flow 300 1.Sodium Hydroxide- 100 g 50 ltrs 150ltrs Filtration -1 min 1.Sodium Hydroxide -100g 07 Chromatography -1 300 2.Potassium phosphate Mins monobasic - 100g 3.Potassium phosphate 100 ltrs 100 ltrs dibasic - 100 g 4.Sodium Chloride – 0.8 kg 5.Chromatography resin-10ltrs

06 Tangential Flow 300 1.Sodium Hydroxide- 100 g 50 ltrs 50 ltrs Filtration -2 & mins Diafiltration Sodium Hydroxide -100g 07 Chromatography -2 300 Sodium phosphate Mins monobasic - 100g Sodium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 0.8kg Chromatography resin-10ltrs

120

Cont…

08 Tangential Flow 300 1.Sodium Hydroxide- 100 g 50 ltrs 50 ltrs Filtration -3 & mins Diafiltration Sodium Hydroxide -100g 09 Chromatography -3 300 Sodium phosphate Mins monobasic - 100g Sodium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 0.8 kg Chromatography resin-10ltrs

10 Tangential Flow 300 Sodium Hydroxide- 100 g 100 ltrs 100 ltrs Filtration -4 & mins Diafiltration 11 Formulation & 60 Filtration Mins 12 Lyophilization 3 days 5 ltrs 13 Packing 60 Mins 14 Cleaning 300 1% Cleaning Solution 1200 ltrs 1200 Ltrs

Sl No SUMMARY

01 Water Consumption/Batch 1860 Ltrs

02 Liquid Waste 1855ltrs

03 Solid Waste 1 kg

04 Process Time 7 days

121

MANUFACTURING FLOW CHARTS PRODUCT NAME: Recombinant human Insulin

Seed Culture Yeast Media Preparation BIOREACTOR

(FERMANTATION)

Centrifugation

Filtration

Tangential Flow Filtration

1 ( TFF / UF)

Chromatography 1

Tangential Flow Filtration & Dia filtration 2

Chromatography 2

Tangential Flow Filtration & Diafiltration 3

Chromatography 3

Tangential Flow Filtration &

Diafiltration 4

Formulation & Filtration

Lyophilization

122

MATERIAL BALANCE SHEET PER BATCH Product: Recombinant Human insulin Batch Size: 5 X 106Units

Sl.No Raw Material Consumption Per Batch 1 Hydrochloric Acid 1.0 Ltrs.

2 Activated Charcoal 5 gms

3 Potassium Phosphate Monobasic 100 grms.

4 Potassium Phosphate Dibasic 100 grms.

5 Sodium Phosphate Monobasic 200 grms.

6 Sodium Phosphate Dibasic 200 grms.

7 Sodium Chloride 2.4 Kgs.

8 Yeastmedium 11.0 kgs.

9 Antifoam agent 1.0Ltrs.

10 Sodium Hydroxide 1.70Kgs.

11 Chromatography resin* 30 Ltrs.

* Note: Chromatographic resins will be reused.

123

PRODUCT NAME: Recombinant human Insulin PROCESS AND WATER BALANCE PER BATCH – 5 X 106Units

SL PROCESS Time Material Consumption Water Waste Generated No consumption Liquid Solid 01 Seed Culture 2 days 1.Inoculum 2.Yeast medium -1.0 kg 10 ltrs

02 Media Preparation 120mins 1.Yeast Medium – 10.0 kgs 100 ltrs

03 Bioreactor/ days 1.Sodium Hydroxide – 1 kg Fermentation 2.Hydrochloric acid – 1 ltr 3.Antifoam - 1ltr

Centrifugation 300 04 min 1 kg

05 Filtration 60 min

06 Tangential Flow 300 1.Sodium Hydroxide- 100 g 50 ltrs 150ltrs Filtration -1 min 1.Sodium Hydroxide -100g 07 Chromatography -1 300 2.Potassium phosphate Mins monobasic - 100g 3.Potassium phosphate 100 ltrs 100ltrs dibasic - 100 g 4.Sodium Chloride – 0.8 kg 5.Chromatography resin-10ltrs

06 Tangential Flow 300 1.Sodium Hydroxide- 100 g 50 ltrs 50 ltrs Filtration -2 & mins Diafiltration Sodium Hydroxide -100g 07 Chromatography -2 300 Sodium phosphate Mins monobasic - 100g Sodium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 0.8kg Chromatography resin-10ltrs

124

Cont…

08 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 50 ltrs Filtration -3 & mins Diafiltration Sodium Hydroxide -100g 09 Chromatography -3 300 Sodium phosphate Mins monobasic - 100g Sodium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 0.8 kg Chromatography resin-10ltrs

10 Tangential Flow 300 Sodium Hydroxide- 100 g 100 ltrs 100ltrs Filtration -4 & mins Diafiltration 11 Formulation & 60 Filtration Mins 12 Lyophilization 3 days 5 ltrs 13 Packing 60 Mins 14 Cleaning 300 1% Cleaning Solution 1200 ltrs 1200 Ltrs

Sl No SUMMARY

01 Water Consumption/Batch 1860Ltrs

02 Liquid Waste 1855ltrs

03 Solid Waste 1 kg

04 Process Time 7 days

125

MANUFACTURING FLOW CHARTS PRODUCT NAME: Recombinant human albumin

Seed Culture Yeast Media Preparation BIOREACTOR

(FERMANTATION)

Centrifugation

Filtration

Tangential Flow Filtration

1 ( TFF / UF)

Chromatography 1

Tangential Flow Filtration & Dia filtration 2

Chromatography 2

Tangential Flow Filtration & Diafiltration 3

Chromatography 3

Tangential Flow Filtration &

Diafiltration 4

Formulation & Filtration

Lyophilization

126

MATERIAL BALANCE SHEET PER BATCH Product: Recombinant human albumin Batch Size: 4 kgs

Sl.No Raw Material Consumption Per Batch 1 Hydrochloric Acid 1.0 Ltrs.

2 Activated Charcoal 5 gms

3 Potassium Phosphate Monobasic 100 grms.

4 Potassium Phosphate Dibasic 100 grms.

5 Sodium Phosphate Monobasic 200 grms.

6 Sodium Phosphate Dibasic 200 grms.

7 Sodium Chloride 2.4 Kgs.

8 Yeast medium 11.0 kgs.

9 Antifoam agent 1.0Ltrs.

10 Sodium Hydroxide 1.70Kgs.

11 Chromatography resin* 30 Ltrs.

* Note: Chromatographic resins will be reused.

127

PRODUCT NAME: Recombinant human albumin PROCESS AND WATER BALANCE PER BATCH – 4kgs

SL PROCESS Time Material Consumption Water Waste Generated No consumption Liquid Solid 01 Seed Culture days 1.Inoculum 2.Yeast medium - 1.0 kg 10 ltrs

02 Media Preparation 120mins 1.Yeast Medium – 10.0 kg 100 ltrs

03 Bioreactor/ days 1.Sodium Hydroxide – 1 kg Fermentation 2.Hydrochloric acid – 1 ltr 3. Antifoam - 1ltr

Centrifugation 300 04 min 1 kg

05 Filtration 60 min

06 Tangential Flow 300 1.Sodium Hydroxide- 100 g 50 ltrs 150ltrs Filtration -1 min Sodium Hydroxide -100g 07 Chromatography -1 300 Potassium phosphate Mins monobasic - 100g Potassium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 0.8 kg Chromatography resin-10ltrs

06 Tangential Flow 300 1.Sodium Hydroxide- 100 g 50 ltrs 50 ltrs Filtration -2 & mins Diafiltration 1.Sodium Hydroxide -100g 07 Chromatography -2 300 2.Sodium phosphate Mins monobasic - 100g 3.Sodium phosphate 100 ltrs 100ltrs dibasic - 100 g 4.Sodium Chloride – 0.8 kg 5.Chromatography resin-10ltrs

128

Cont…

08 Tangential Flow 300 1.Sodium Hydroxide- 100 g 50 ltrs 50 ltrs Filtration -3 & mins Diafiltration Sodium Hydroxide -100g 09 Chromatography -3 300 Sodium phosphate Mins monobasic - 100g Sodium phosphate 100 ltrs 100ltrs dibasic - 100 g Sodium Chloride – 0.8 kg Chromatography resin-10ltrs

10 Tangential Flow 300 Sodium Hydroxide- 100 g 100 ltrs 100ltrs Filtration -4 & mins Diafiltration 11 Formulation & 60 Filtration Mins 12 Lyophilization 3 days 5 ltrs 13 Packing 60 Mins 14 Cleaning 300 1% Cleaning Solution 1200 ltrs 1200 Ltrs

Sl No SUMMARY

01 Water Consumption/Batch 1860 Ltrs

02 Liquid Waste 1855 ltrs

03 Solid Waste 1 kg

04 Process Time 7 days

129

MANUFACTURING FLOW CHARTS PRODUCT NAME: Recombinant Somatropin

Seed Culture Yeast Media Preparation BIOREACTOR

(FERMANTATION)

Centrifugation

Filtration

Tangential Flow Filtration

1 ( TFF / UF)

Chromatography 1

Tangential Flow Filtration & Dia filtration 2

Chromatography 2

Tangential Flow Filtration & Diafiltration 3

Chromatography 3

Tangential Flow Filtration &

Diafiltration 4

Formulation & Filtration

Lyophilization

130

MATERIAL BALANCE SHEET PER BATCH Product: Recombinant Somatropin Batch Size: 40 gms

Sl.No Raw Material Consumption Per Batch 1 Hydrochloric Acid 1.0 Ltrs.

2 Activated Charcoal 5 gms

3 Potassium Phosphate Monobasic 100 grms.

4 Potassium Phosphate Dibasic 100 grms.

5 Sodium Phosphate Monobasic 200 grms.

6 Sodium Phosphate Dibasic 200 grms.

7 Sodium Chloride 2.4 Kgs.

8 Yeast medium 11.0 kgs.

9 Antifoam agent 1.0Ltrs.

10 Sodium Hydroxide 1.70Kgs.

11 Chromatography resin* 30 Ltrs.

* Note: Chromatographic resins will be reused.

131

PRODUCT NAME: Recombinant Somatropin PROCESS AND WATER BALANCE PER BATCH – 40 gms

SL PROCESS Time Material Consumption Water Waste Generated No consumption Liquid Solid 01 Seed Culture 2days 1.Inoculum 2.Yeast medium -1.0 kg 10 ltrs

02 Media Preparation 120mins 1.Yeast Medium – 10.0 kgs 100 ltrs

03 Bioreactor/ days 1.Sodium Hydroxide – 1 kg Fermentation 2.Hydrochloric acid – 1 ltr 3.Antifoam - 1ltr

Centrifugation 300 04 min 1 kg

05 Filtration 60 min

06 Tangential Flow 300 1.Sodium Hydroxide- 100 g 50 ltrs 150ltrs Filtration -1 min 1.Sodium Hydroxide -100g 07 Chromatography -1 300 2.Potassium phosphate Mins monobasic - 100g 3.Potassium phosphate 100 ltrs 100 ltrs dibasic - 100 g 4.Sodium Chloride – 0.8 kg 5.Chromatography resin-10ltrs

06 Tangential Flow 300 1.Sodium Hydroxide- 100 g 50 ltrs 50 ltrs Filtration -2 & mins Diafiltration 1.Sodium Hydroxide -100g 07 Chromatography -2 300 2.Sodium phosphate Mins monobasic - 100g 3.Sodium phosphate 100 ltrs 100 ltrs dibasic - 100 g 4.Sodium Chloride – 0.8 kg 5.Chromatography resin-10ltrs

Cont… 132

08 Tangential Flow 300 Sodium Hydroxide- 100 g 50 ltrs 50 ltrs Filtration -3 & mins Diafiltration 1.Sodium Hydroxide -100g 09 Chromatography -3 300 2.Sodium phosphate Mins monobasic - 100g 3.Sodium phosphate 100 ltrs 100ltrs dibasic - 100 g 4.Sodium Chloride – 0.8 kg 5.Chromatography resin-10ltrs

10 Tangential Flow 300 1.Sodium Hydroxide- 100 g 100 ltrs 100 ltrs Filtration -4 & mins Diafiltration 11 Formulation & 60 Filtration Mins 12 Lyophilization 3 days 5 ltrs 13 Packing 60 Mins 14 Cleaning 300 1% Cleaning Solution 1200 ltrs 1200 Ltrs

Sl No SUMMARY

01 Water Consumption/Batch 1860 Ltrs

02 Liquid Waste 1855 ltrs

03 Solid Waste 1 kg

04 Process Time 7 days

133

3.5. MAJOR RAW MATERIALS

Many raw materials are required for the chemical synthesis processes used by the industry. These include organic and inorganic compounds and are used in gas, liquid, and solid forms. During transportation of the raw material the procedures given in the MSDS will be followed. The mode of transport is on roads. The raw materials and their quantities to be used in proposed production facility are mentioned in the table below.

Raw materials to be used in the manufacturing process (emerging scenario) (per annum)

Sl.No. Materials Quantity

1 Activated Charcoal 15Kgs

2 Hydrochloric acid 30 Ltrs.

3 Potassium Phosphate Monobasic 30 Kgs.

4 Potassium Phosphate dibasic 30 Kgs.

5 Antifoam Agent 30 Ltrs.

7 Sodium chloride 90 Kgs.

8 Sodium Phosphate Monobasic 60 Kgs.

9 Sodium Phosphate dibasic 60 Kgs.

10 Sodium Hydroxide 53 Kgs.

11 Cell culture medium 3300 Ltrs.

12 Chromatography grade silica 90 Kgs

13 Cleaning Solution 100 Ltrs.

134

14 Ammonium sulphate 395 Kgs

15 Sodium acetate 240Kgs

16 Acetic acid 40Ltrs

17 Weak anion exchange resin 50Ltrs

18 Weak cation exchange resin 50Ltrs

19 Strong anion exchange resin 20Ltrs

20 Strong cation exchange resin 20Ltrs

21 Hydrophobic interaction resin 20Ltrs

22 Gel filtration resin 20Ltrs

PRODUCT MIX- EMERGING SCENARIO

BLOCK NO. OF AVG. DURATION/ POSSIBLE PRODUCTS MFD. PRODUCT BATCHES/ AT A TIME ANNUM API BLOCK (existing 1 7 days 52 facility) RECOMBINANT BLOCK 1 14 days 26 (emerging facility)

RAW MATERIAL - EMERGING SCENARIO MATERIAL QTY. IN API QTY. IN TOTAL QTY./ BLOCK/ annum RECOMBINAN ANNUM T BLOCK/ annum

Activated 10Kgs 5Kgs 15Kgs Charcoal

135

Hydrochloric 45Ltrs 30Ltrs 75 Ltrs. acid

Potassium 60Kgs 30Kgs 90Kgs Phosphate Monobasic

Potassium 60Kgs 30Kgs 90Kgs Phosphate dibasic

Antifoam Agent 60Ltrs 30Ltrs 90Ltrs

Sodium chloride 400Kgs 90Kgs 490Kgs

Sodium 220Kgs 60Kgs 280Kgs Phosphate Monobasic

Sodium 90Kgs 60Kgs 150Kgs Phosphate dibasic

Sodium 200Kgs 53Kgs 253Kgs Hydroxide

Cell culture - 3300Ltrs 3300 Ltrs. medium

Chromatography - 90Kgs 90 Kgs grade silica

Cleaning 250Ltrs 100Ltrs 350Ltrs Solution

Ammonium sulphate 1200 Kgs 395Kgs 1595Kgs

Sodium acetate 80 Kgs 240Kgs 320Kgs

Acetic acid 100Ltrs 40Ltrs 140Ltrs

Weak anion 50Ltrs 50Ltrs 100Ltrs

136

exchange resin

Weak cation 50Ltrs 50Ltrs 100Ltrs exchange resin

Strong anion 20Ltrs 20Ltrs 40Ltrs exchange resin

Strong cation 20Ltrs 20Ltrs 40Ltrs exchange resin

Hydrophobic 20Ltrs 20Ltrs 40Ltrs interaction resin

Gel filtration resin 20Ltrs 20Ltrs 40Ltrs

Polyaminated 30Kgs - 30Kgs polysacarhide

Uroprotein 200Kgs - 200Kgs

Benzathonoium 10Kgs 10Kgs 20Kgs chloride Bovine pulmonary 120Kgs - 120Kgs extract Isopropyl alcohol 30Ltrs 30Ltrs 60Ltrs

SOLVENT USAGE, STORAGE AND RECOVERY

-Solvent is used in the following, a. For manufacturing operations like extraction, precipitation, etc. b. For analysis in Q.C/R&D b. Surface sterilization and sanitization in Production c. Preservative for some of the resins and media -Spent solvent stored in metal drums and disposed to recovery company.

STORAGE & TRANSPORTATION OF RAW MATERIALS & PRODUCTS

137

Raw material are stored in containers in the storage area, Products are stored in product house. Raw materials are transported through trucks to the plant and within the plant small vehicles such as forklifts are used to move the raw materials. Products are transported through vehicles according to the requirement and capacity of the customer requirement.

STORAGE: Industry will provide adequate and proper storage facilities for all the raw materials and finished products. Corrosive substances will be stored away from the moisture. Solid raw material will be stored in covered area and liquid raw material will be stored in closed horizontal tank. Hazardous chemicals and solid wastes will be stored away from other plant activities. The storage yard of chemicals will be isolated and it will be equipped with all necessary safety measures. In cover-shed area provide natural ventilation system, which consider as 15% open area of all covered area.

HANDLING: All the raw materials, finished products and by - products will be handled as per the standard practice. For proper handling, company will adapt good housekeeping technology to entire shed. To avoid any leakage or spillage of chemicals from all storage tanks, third party inspects transfer lines, valves, fittings and every joint periodically.

TRANSPORTATION: All the necessary precautions will be taken while carrying out transport of the above materials as per the Hazardous Rules of transportation. The vehicles for transportation of raw materials, by - products and products will be parked at specified loading facilities where there will be a provision of fire extinguishers. The finished product will be transported by road, rail and ship route.

3.6: WATER CONSUMPTION Number of employees increases from 46 to 86 numbers in the facility. The water consumption is for meeting the personal needs workers. Hence the total water consumption is estimated to be 1000 LPD. Wastewater discharge considering 80% diversity is 800 liters/day and it is discharged to Septic tank and Soak pit for the treatment.

Water for domestic and operation phases will be procured through Bore well. Average fresh water daily water requirement during operation phase is estimated as 12.5 KLD, out of which approximate 7.05 KLD wastewater generated. The breakup of daily and annual water requirement for operation phase and wastewater generation is given in below table.

138

WATER BALANCE- EMERGING SCENARIO/ DAY

Water consumption Consumption (L/day) Discharge (L/day) purpose API Rec. Total API Block Rec. Block Total Block Block 1. Domestic (toilet, 500 500 1000 400 400 800 canteen etc.)

2. Gardening/ 5000 - 5000 - - - Landscaping 3. Industrial purpose 1100 1400 2500 1050 1350 2400

a. Process 700 950 1650 650 900 1550 b. Washing 400 450 850 400 400 800 /cleaning 4. QC/ R&D 500 - 500 500 - 500 5. DM/ Softener 500 500 1000 500 500 1000 rejects

Total 8700 3800 12500 3500 3550 7050

WATER BALANCE- EMERGING SCENARIO/ ANNUM Water consumption Consumption (KL/annum) Discharge (KL/annum) purpose API Block Rec. Total API Block Rec. Total Block Block 1.Domestic (toilet, 126 126 252 101 101 202 canteen etc.)

2.Gardening/ 1260 - 1260 - - - Landscaping

3.Industrial purpose 277 294 571 265 284 549

139

a. Process 177 200 377 165 189 354

b.Washing /cleaning 100 94 194 100 95 195

4. QC/ R&D 126 - 126 126 - 126

5. DM/ Softener rejects 126 126 252 126 126 252

Total 2192 840 3032 883 795 1678

Note: API Block: 36 Batches/ 252 working days Rec. Block: 15 Batches/ 210 working days

140

WATER BALANCE CHART

Source : Borewell Total Water consumption:

12500 ltr

Domesti c purpose: 1000 Gardening/Landscaping QC/R & D: 500 DM/ Softener Industrial Purpose ltrs : 5000 ltr ltr rejects:1000 ltr

Waste water Generation:

800 Ltr Process: 1650 ltr Washing /cleaning: 850

ltr

Discharge to septic tank Wastewater: 1550 ltr Wastewater: 800 ltr and soak pit

Discharge to CETP

141

3.7. WASTE GENERATION AND MANAGEMENT

WASTE WATER DISPOSAL- EMERGING SCENARIO

Effluent source Treatment mechanism Final disposal point

1. Domestic - Discharged to Septic tank and Soak pits

2. Industrial Storage tank- Industrial effluent will be sent to Existing capacity : 30KL X 2 Common Effluent treatment plant Proposed capacity (CETP)- M/s. Govind Solvents Pvt. addition: 30KL X 3 Ltd., for treatment and disposal

EFFLUENT TREATMENT FACILITY AT CETP

Name of CETP provider M/s. Govind solvents Pvt. Ltd., No.19(P)-22, Kunigal Industrial area, Kunigal tq., Tumkur- dist.

Distance from the project site ~ 40 Kms Mode of transport Tanker by CETP provider

SOLID WASTE GENERATION AND HANDLING:

Source of solid Treatment mechanism Final disposal point waste

1. Domestic 20 kgs/day (Including canteen Waste will be disposed of at a site as waste) approved by local authority.

2. Industrial Storage tank- Hazardous waste is proposed to be sent to process Existing capacity : 200Kgs Common Solid Waste Treatment Plant Proposed capacity (CSWTP) of M/s Bangalore Incinerators addition: 200Kgs Pvt. Ltd., for treatment and disposal

150

HAZARDOUS WASTE GENERATION

Cat. Type Category Quantity Method of handling /disposal No.

01 Used Oil 5.1 0.2 KL/year Shall be collected

02 Oil & chemical 5.2 500 kgs/year Handed over to M/s Bangalore contaminated Incinerators Pvt. Ltd., for cotton waste treatment and disposal

03 Residue/chemical 33.3 100 nos Handed over to KSPCB containers authorized recycler

HAZARDOUS WASTE TREATMENT FACILITY AT CETP

Name of CSWTP 1. M/s. Bangalore Incinerators Pvt. Ltd. provider No.28, KIADB Industrial area, Kunigal- tq, Tumkur-dist. 2. M/s. Medicare Pvt. Ltd., Dabaspet, Bangalore- dist Distance from the project ~ 40 Kms site Mode of transport by CSWTP provider

151

BIOMEDICAL WASTE TO BE GENERATED DURING OPERATION PHASE OF THE PROJECT

Sl. No Type Quantity Method of Handling /disposal

01 General biomedical Handed over to KSPCB authorized waste from R&D incinerator

3.7.1. SOLID AND HAZARDOUS WASTE MANAGEMENT: All the wastes generated ranging from the most inert to the most toxic, shall be collected and managed in a scientific manner as mentioned in the above tables. A waste tracking system will be developed and maintained to keep a record of the types and quantities of waste present at the job sites. This record shall be used to monitor the effectiveness of the waste management program. All disposals will meet manifest system and relevant regulatory norms of the Karnataka State Pollution Control Board and the Ministry of Environment and Forests.

3.7.2. AIR EMISSION AND POLLUTION CONTROL:

Source of air emission includes stacks attached to Air Handling units and DG sets. Details of gases emission from project activities are provided in table.

Air pollution Fuel Stack height Air pollution control source consumption

D.G. set- 60 15 L/hr diesel 3m ARL with Stack kVA acoustic enclosures Air Handling __ 3 m Stack units – 6 nos. ARL(Individual)

3.7.3. NOISE MANAGEMENT For the proposed project impact on noise environment can be due to:  Noise from the plant operations, machinery and utilities with the immediate receptors exposed to occupational noise levels; and

152

 Noise generation due to plying of vehicles on the roads for staff commitment and for bringing raw material and taking finished products. Some typical noise sources include the following:  Operation of DG sets;  Operation of pumps  Operation in other utility areas. Noise level for various equipment will be in the range of 70 dB (A) to 80 dB(A). Provision of personal protective equipment will made for personnel working in high noise generation area. Acoustic measures or isolation will be taken up for equipment generating noise level greater than 75 dB(A). A green belt/landscape planned all around project covering 30% of the total area under green cover. This will considerably reduce fence level noise level.

3.8. POWER REQUIREMENT

Power demand during operation phase is estimated to be around 55 kVA. The supply of power would be met through BESCOM supply. The power supply would be through 66 kV, 2500 MVA, 21.86 kA, 50 Hz, Solidly Earthling system. The variation for voltage and frequency shall be: High Voltage: 66kV + 10% Low Voltage: 400 V + 10% Frequency: 50 Hz + 3%

Outdoor installation will be through a 66 kV overhead HT line with switch yard accessories. Metering would be provided by BESCOM in 66 kV switch yard. Sub-station would be located at boundary of the Project site. Power supply from BESCOM will be used for office and other utility system.

Diesel generators of 60 kVA will be provided as source for power backup arrangement.

153

CHAPTER – 4 SITE ANALYSIS

4.1. ROAD CONNECTIVITY: The site is bounded by 10 m wide road on northern boundary. This road is connected to Tumkur Sira Road Service road within 1km radius of the site.

4.2. TOPOGRAPHY: The project site is located at Plot no.191-A, KIADB Industrial area 1st stage, Vasanthanarasapura, Kora Hobli, Tumkur tq. and dist. - 572128 The counter map of the site is shown below in the below figure

151

4.3. LAND USE

The use of land is determined both by physical factors such as topography, climate, and soil types as well as human factors such as population density, technological capability, culture & tradition etc. Land use has a major impact on natural resources including water, soil, nutrients, plants and animals. Land is a limited commodity in every context and hence, its use should be beneficial to the humanity, “Land Use” in the urban planning context means the use to which pockets or zones of land are put to. It could be residential, commercial, industrial, parks and open space, play ground, traffic and transportation etc. The use to which land should be put to must be optional.

4.4. GEOLOGICAL SETTING The district is generally, an open tract except in the south of Kunigal taluk, where the area is covered with intensive thick forests with hills. The other parts consist of mainly undulating plains interspersed with clumps of tall and well grown trees. To the east of Tumkur and north of Devarayana Durga, the region presents beautiful scenery of hill ranges intersected by cultivated valleys.

Long ranges of hills running roughly south-south east direction occupy the western part of the district. A narrow range of granitic hills grouped under closepet granites occupies the eastern part. These hills pass through the taluks of Pavagada, Madhugiri, Koratagere and northern parts of Tumkur. In the eastern part, the hills comprising of schistose rocks passes through Chikkanayakanahalli, Sira, and Gubbi taluks. The prominent hills in the eastern range of hills are Kamandadurga (1077 m), Nidugal (1148m), Madhugiridurga (1199 m), Channarayadurga (1138 m) Koratagiri (879m), Devarayanadurga (1187m), Nijogal (1086m), Hutridurga (1130) and Huliyardurga (844m) above mean sea level. The landmass in the plains ranges between 450 to 840 m above msl. While hilly areas range between 840 to 1500 m above msl.

4.5. SOIL CLASSIFICATION Major types of soils occurring in the district are 1) Red loamy soil, 2) Red sandy soil and 3) Mixed red and black soils. Red loamy soil occurs in eastern central part of the district covering 152

Koratgere, Tumkur, and eastern parts of Madhugiri and Kunigal Taluks. Red Sandy soil covers rest of the area except very small area in the northwestern part of C.N. Halli Taluk where Mixed Red and Black soil occur. Red soils have good drainage but poor in lime and bases.

LABORATORY TESTING Following laboratory tests were conducted on soil samples for the 4 sampling locations as per the IS: 3025 and the results are tabulated. The soil sampling locations are given in Table 3.3.  Grain size by sieve analysis.  Prominent chemical parameters Sample no. Name of Sampling Distance in Km Direction from the Station Plant site

S 1 Kenchenahalli 4.1 km NE

S 2 Doddanapalya 3.5 km SE

S 3 Thimmarajanahalli 4.1 km SW

S 4 Kempanadodendri 4.6 km SE

S 5 Kenchenahalli 4.1 km NE

TABLE 3.4: PHYSICO-CHEMICAL CHARACTERISTICS OF THE SOIL Sl. No. Physical Analysis Results Parameters S 1 S2 S3 S4 S5

1 Bulk density 1.49 1.53 1.54 1.20 1.15

(Kg/cm3)

2 Texture and Silty Sand Loam Loam Sandy Loamy

153

type loam sand

3 Void Porosity 21 17 19 20 22

4 Water holding 21.3 34.2 32.4 20.3 19.2 capacity

5 pH 6.4 5.6 6.2 6.5 6.7

6 Electrical 0.23 0.29 0.33 0.39 0.36 Conductivity (µS/cm)

Sl. Soil Texture Analysis Results No Characteristics S1 S2 S3 S4 S5

1 % of Sand 63 67 72 62 76

2 % of Silt 13 24 09 30 08

3 % of Clay 24 09 19 08 16

Sl. Exchangeable Analysis Results No Cations S1 S2 S3 S4 S5

1 Calcium (meq/100g) 5.5 4.2 3.6 4.3 2.5

2 Magnesium 4.2 3.1 3.3 3.0 1.4 (meq/100g)

3 Sodium (meq/100g) 0.65 0.63 0.49 0.47 0.45

154

4 Potassium(meq/100g) 0.76 0.96 0.61 0.82 0.67

Sl. Nutrients Analysis Results No S1 S2 S3 S4 S5

1 Organic Carbon(%) 0.8 1.1 2.1 1.1 0.74

2 Organic Matter (%) 1.3 2.1 2.9 2.6 1.8

3 Nitrogen (%) 0.057 0.3 0.2 0.081 0.07

4 Total Phosporous (%) 0.015 0.049 0.045 0.035 0.019

5 Potassium (%) 0.27 0.45 0.43 0.30 0.33

Sl. Micro Nutrients Analysis Results No S1 S2 S3 S4 S5

1 Iron (mg/kg) 1.6 3.8 2.6 1.4 4.0

2 Copper (mg/kg) 0.6 1.2 1.2 0.8 1.0

3 Zinc (mg/kg) 1.4 3.4 2.8 1.2 3.1

4 Manganese ((mg/kg) 1.9 3.3 3.1 1.5 3.5

4.5.1. WATER ENVIRONMENT Water environment includes three environmental settings, i.e. ground, surface and marine. Baseline data with regard to these three environmental settings should be generated. 4.5.2. GROUND WATER

155

The district is underlain by meta sediments (limestone) and meta volcanic (quartzite and schists) of Dharwar Group, Peninsular gneisses and Clospet granites of Pre Cambrian age, which are intruded by pegmatite and dolerite dykes. Laterite occurs on the top of the hills south of Bukkapatna as small patch. Joints are observed in general in N. E – S.W to N.N.E – S.S.W and NW – SE to NNW – SSE directions. The alluvial patches are generally seen along the major streams as narrow discontinuous patches particularly in granite country. It comprises medium to coarse grained sand with silt and clay at many places and is largely controlled by topography of the basement crystalline in the area. The maximum thickness of the alluvium in the Suvarnamukhi basin is 14 m. The alluvium in Jayamangali and Kumudavathy rivers is sandy in nature and attains a thickness of only 10 to 13 m

4.5.3. OCCURRANCE AND MOVEMENT OF GROUND WATER: Ground water occurs in weathered and jointed zones of gneisses, granites and schists and alluvium in unconfined or water table conditions where as it occurs in semi confined to confined conditions in fractured formations.

Unconfined aquifer system is developed by dug wells, shallow bore wells and filter points. This zone extends down to 13-20 mbgl depth. The yield range of irrigation dug wells in alluvium is 300-600 m3/day where as the same in weathered formation is 11 to 250 m3/day. The yield of filter points is in the range of 220-350 m3/day. As the filter points are located in alluvium of limited thickness, many of them become dry during summer. Due to over exploitation in many pockets, this zone is getting dried up gradually.

Semi confined to confined aquifer is formed due to fractures in hard formations. This aquifer system is developed by bore wells ranging in depth up to 200m. Its yield ranges up to 1200m3/day, and specific yield ranges from 2 to 173 lpm/m.

156

Ground Structure Depth Yield Aquifer Specific water Range range Material Yield conditions (mbgl) (m3/day) (lpm/m) Unconfined DW 3-16 300-600 Alluvium - DW & < 30 11-250 Weatherd And 1-158 Shallow jointed formation bore wells Filter points >20 220-350 Alluvium Semi confined BW Up to 200 > 1200 Fractured 2-173 to Confined hard rock

4.5.4. GROUND WATER QUALITY

Water samples are collected from selected dug wells (National Hydrograph monitoring Stations) annually for chemical analysis. The analysis results indicate that in general the quality of ground water is potable for drinking and suitable for irrigation purposes. However high concentration of fluoride (>1.5 mg/lit) is observed in northern part of Pavagada and Madhugiri taluks and as small patches in Sira taluk. High concentration of nitrates (>45 mg/lit) is observed in major parts of Pavagada, Sira, Madhugiri, Koratagere and central part of Chiknayakanahalli and western parts of Gubbi taluks. This may be attributed to more use of fertilizers. High chloride concentrations are observed in central part of Pavagada and Madhugiri taluks and in northwestern parts of Chiknayakanahalli taluk. Electrical conductivity is in permissible range in general. Ground water quality map of the district is shown in figure.

157

158

4.5.5. GROUND WATER QUALITY OBERVATIONS:

Most of the villages in the project area have hand pumps and wells, as most of the residents of these villages make use of this water for drinking and other domestic uses.  The analysis results indicate that the pH ranges in between 7.4 to 7.9, which is well within the specified standard of 6.5 to 8.5;  The Total Dissolved Solids (TDS) concentrations were found to be ranging in between 440 to 790 mg/l;  Chlorides were found to be in the range of 50.4 mg/l to 205.3 mg/l;  Sulphates were found to be in the range of 8.8 mg/l to 16.0 mg/l; and  Metals: Iron is found in 0.01 mg/l to 0.02 mg/l and zinc was varied between mg/l to 0.03 mg/l.

The ground water quality in the study area does not indicate any industrial contamination. Based on the above results it is evident that all of the parameters in ground water fairly meet the desirable standard limits of IS: 10500.

4.5.6. GROUND WATER QUALITY OBSERVATION CHART

Sr.No Parameters Units IS:10500 GW1 GW2 GW3 GW4 Limits 1 pH - 6.5 -8.5 7.5 7.6 7.5 7.7 2 Colour Hazen 5 (25) "I 1 2 2 3 Taste Agreeable Ag Ag Ag Ag 4 Odour - UO UO UO I.10 UO 5 Conductivity NS/cm $ 750.0 1082.0 710.0 852.0 6 Turbidity NTU 5(10) 2 2 1 3 7 TDS mg/I 500 (2000) 485.0 703.3 460.0 550.0 Total Hardness as 8 mg/I 300 (600) 238.0 345.4 221.8 291.5 CaCO, 9 Total Alkalinity mg/I 200 (600) 261.5 277 255.3 295.2 10 Calcium as Ca moil 75 (200) 53.4 68.2 51.2 72.5 11 Magnesium as Mg mg/I 30 (100) 25.4 42.5 22.8 26.8 12 Residual Chlorine mg/I 0.2 Min. <0.2 <0.2 <0.2 <0.2 159

13 Boron moil 1 0.01 0.03 0.02 0.01 14 Chlorides as CI mail 250 (1000) 72.5 173.4 62.7 88.5 15 Sulphates as SO, mg/I 200 (400) 10.2 13.6 9.2 12.4 16 Fluorides as F mo/I 1.0 (1.5) 0.7 0.8 0.5 0.7 17 Nitrates as NO, mg/I 45 (NR) 8.0 11.2 7.2 8.2 18 Sodium as Na mg/I $ 60.4 81.5 57.6 62.5 19 Potassium as K mg/I $ 12.5 21.8 11.7 15.2 20 Phenolic Compounds mg/I 0.001 <0.001 <0.001 <0.001 <0.001 (0.002) 21 Cyanides mg/I 0.05(NR) <0.02 <0.02 <0.02 <0.02 22 Anionic Detergents moil 0.2 (1.0) <0.1 <0.1 <0.1 <0.1 23 Mineral Oil mg/I 0.01 (0.03) <0.01 <0.01 <0.01 <0.01 24 Cadmium as Cd mg/I 0.01 (NR) <0.01 <0.01 <0.01 <0.01 25 Arsenic as As moil 0.01 (NR) <0.01 <0.01 <0.01 <0.01 26 Copper as Cu mg/I 0.05 (1.5) <0.01 <0.01 <0.01 <0.01 27 Lead as Pb mg/I 0.05 (NR) <0.01 <0.01 <0.01 <0.01 28 Manoanese as Mn moil 0.1 (0.3) <0.01 <0.01 <0.01 <0.01 29 Iron as Fe mg/I 0.3 (0.1) 0.02 0.01 0.02 0.02 30 Chromium as Cr° mg/I 0.05 (NR) <0.05 <0.05 <0.05 <0.05 31 Selenium as Se mg/I 0.01 (NR) <0.01 <0.01 <0.01 <0.01 32 Zinc as Zn m4/1 5(15) 0.03 0.02 0.02 0.01 33 Aluminium as Al mC1/1 0.03 (0.2) <0.01 <0.01 <0.01 <0.01 34 Mercury as Ho moil 0.001(NR) <0.001 <0.001 <0.001 <0.001 35 Pesticides moll Absent Absent Absent Absent Absent 36 E.Coli Absent Absent Absent Absent Absent 37 Total Coliform MPN/100 ml 10 <2 <-, <", <2

4.5.7. SURFACE WATER QUALITY

_ The analysis results indicate that the pH values in the range of 7.2 to 7.6 which is well within the specified standard of 6.5 to 8.5; _ The chlorides and sulphates were found to be in the range of 175 mg/l to 425 mg/l and 130 mg/l to 265 mg/l respectively. It is observed that chlorides and sulphates are within the permissible limits; _ The calcium & magnesium were found to be in the range of 129 mg/l to 144.8 mg/l and 60 mg/l to 118 mg/l respectively; and 160

_ Metals: iron is found in between 0.07 mg/l to 0.09 mg/l and zinc is found ranging between 0.05 mg/l to 0.10 mg/l. The surface water quality in the study area does not indicate any industrial contamination except some parameter. SURFACE WATER QUALITY Parameters Units SW1 SW2

pH - 7./ 7.6 Colour Hazen 22 15 Conductivity uS/cm 3062.0 1865.0 DO mg/I 4.3 4.0 BOD mg/I 62.0 25.0 COD mg/I 193.0 80.4 Total Hardness as mg/I 847.6 569.4 CaCO3

Total Alkalinity mg/I 628 525 Calcium as Ca mg/I 144.8 129 Magnesium as Mg mg/I 118.0 60.0 Chlorides as CI mg/I 425.0 175.0

Residual free Chlorine mg/I <0.2 <0.2

Sulphates as SO. mg/I 265.0 130.0 Fluorides as F mg/I 1.0 0.9 Nitrates as NO3 mg/I 38.9 35.6

Sodium as Na mg/I 292.8 155.0 Potassium as K mg/I 48.2 28.8

Total Boron as B mg/I 0.06 0.04

Phenolic Compounds mg/I <0.001 <0.001 Cyanides mg/I <0.02 <0.02

161

Cadmium as Cd mg/I <0.01 <0.01 Arsenic as As mg/I <0.01 <0.01

Copper as Cu mg/I <0.01 <0.01

Lead as Pb mg/I <0.01 <0.01 Iron as Fe mg/I 0.09 0.07 Chromium as Cr° mg/I <0.05 <0.05 Selenium as Se mg/I <0.01 <0.01

Zinc as Zn mg/I 0.10 0.05 Aluminium as Al mg/I <0.01 <0.01 Mercury as Hg mg/I <0.001 <0.001

SAR - 4.38 2.83 Insecticides mg/I Absent Absent

Anionic Detergents as mg/I <0.1 <0.1 MBAS Total Coliforms MPN/100 8.0 10.0

4.6. CLIMATE DATA

The meteorological data recorded during the study period is very useful for proper interpretation of the baseline information and selection of air quality monitoring locations. Historical data on meteorological parameters will also play an important role in identifying the general meteorological regime of the region.

The representative months for climate are divided into four seasons winter lasts from January to February, summer lasts from March to May, South-West monsoon rains from June to September and North-East monsoon rains from October to December. (Ref: Assessment of Impact to Air Environment: Guidelines for Conducting Air Quality Modeling, Central Pollution Control Board).

162

METHODOLOGY The methodology adopted for monitoring surface weather parameters is as per the norms laid down by Bureau of Indian Standards (IS:8829) and India Meteorological Department (IMD). Secondary information on meteorological conditions for the Panambur region was collected from the IMD station at Bangalore. Data of previous years have been collected and analyzed. The temperature and rainfall variations for the area have been presented in Figure.

4.6.1.WINDS: Winds are strong and are mainly westerly or south - westerly in the south west monsoon months. In the rest of the year, winds are mainly from directions between north and east in the fore-noon and westerly or north-westerly in the afternoons.

4.6.2. CLOUDINESS: Cloudiness is measured in units called Octa (okta). One Octa refers to 1/8 part of the sky covered by clouds. If the whole sky is covered and if it is half of this, the coverage is 4 Octa. The south west monsoon witnesses‟ heavy cloudiness of the sky and it gets reduced in the month of March when the sky is almost clears. But here and there one can see the floating of bigger or medium sized clouds in the sky. Sky is over cast in the coast and ghats during the months of July to august, when the clouds are at a lower level. It rains more than 20 days in a month during this period and the sun is covered for day. In the district, skies are heavily clouded ore over coast on most days in the south-west monsoon season. The number of such heavily clouded days is fewer in the post-monsoon months of October and November. In the rest of the year, skies are generally lightly clouded or clear.

Month Jan Feb Mar Apr May Jun July Aug Sep Oct Nov Dec Annual Avg 7.9 8.2 7.9 8.2 9.0 8.7 9.0 7.4 6.4 6.6 6.6 7.0 7.8

163

4.6.3. AMBIENT AIR QUALITY The study area represents mostly rural/residential environment. Eight ambient air Quality monitoring stations were selected in and around project site and study was conducted as per revised NAAQ standards 2009.

The PM2.5 and PM10 values ranged from 11.6 to 25.2 μg/m3 and 28.7 to 59.7 μg/m3. The SO2 and NOx concentrations varied between 11.2 to 23.3 μg/m3 and 14.5 to 27.9 μg/m3 respectively. The concentrations of other parameters such as CO, O3, Hg and VOCs are observed to be well within the standards. Ambient air quality analysis reveals that these results are well within limits in all locations as per National Ambient Air Quality standards 2009.

164

METHODOLOGY ADOPTED FOR AIR QUALITY SURVEY

The baseline status of the ambient air quality has been assessed through a scientifically designed ambient air quality monitoring network. The design of monitoring network in the air quality surveillance program has been based on the following considerations: • Meteorological conditions on synoptic scale; • The methodology for conducting the baseline environmental survey and selection of sampling locations considered the guidelines given in the EIA manual of the MoEF; • Topography of the study area; • Representatives of regional background air quality for obtaining baseline status; and • Representatives of likely impact areas.

SAMPLING AND ANALYTICAL TECHNIQUES

The air samples were analyzed as per standard methods specified by Central Pollution Control Board (CPCB), IS: 5184 and American Public Health Association (APHA). The techniques used for ambient air quality monitoring and its minimum detectable levels are given in Table

TECHNIQUES USED FOR AMBIENT AIR QUALITY MONITORING Parameters Test Method Minimum Detection Sulphur dioxide (SO2) Modified West and Gaeke Method 4.0Limit mg/m 3

3 Nitrogen dioxide (NO2) Sodium Arsenite Method 9.0 mg/m

PM,0 (Respirable Respirable dust sampler/ High volume 5.0 µg/m' sampling (Gravimetric) Particulate Matter)

PM23 (Particulate matter FRM method/ Low volume sampling 2.0 µg/m' sizeAmmonia c2.5 um)(NH3) (Gravimetric)Indophenol Blue method 20 maim' Carbon monoxide Absorption and extraction followed by 12.5 µg/m' (CO) (3 x S hr) GC-MS analysis Ozone (0,) (3 x S hr) Spectrophotometric method 2.0 mg/m3 Benzene (C61-16) Adsorption and desorption followed by 1.0 ng/m3 GC-MS analysis

165

Benzo(a)pyrene (BaP) Solvent extraction followed by GC- 1.0 ng/m3 MS analysis Lead (Pb) AAS / ICP-MS method after sampling GFFA/ICP-MS - 0.05 on EPM filter paper ng/rni Nickel (Ni) AAS / ICP-MS method after sampling GFFA/ICP-MS - 0.10 on EPM filter paper ng/m3

Arsenic (As) AAS / ICP-MS method after sampling GFFA/ICP-MS - 0.20 on EPM filter paper ng/m3

Duration of Sampling The sampling duration for PM10, PM2.5, SO2, NO2, NH3, C6H6, BaP, Pb, Ni, As and Hg was twenty-four hourly continuous samples per day and CO, O3 and HC was sampled for 8 hrs continuous thrice a day. This is to allow a comparison with the present revised standards mentioned in the latest Gazette notification of the Central Pollution Control Board (CPCB) (November 16, 2009). AIR QUALITY SAMPLING LOCATIONS Station Code Name of the Distance wrt plant Direction boundary (km) Station AAQ1 Project site -- --

AAQ2 Project site at entrance -- --

AAQ3 Kenchenahalli 4.1 km NE Location-1 AAQ4 Kenchenahalli 4.1 km NE Location -2 AAQ5 Doddanapalya 3.5 km SE Location -1 AAQ6 Doddanapalya Location 2 AAQ7 Thimmarajanahalli 4.1 km SW

AAQ8 Kempanadodendri 4.6 km SE

166

SUMMARY OF AMBIENT AIR QUALITY RESULTS

Code Location PM10 PM2.5

Min Max Avg 98% Min Max Avg 98% AAQ1 Project site 37.3 59.7 46.6 59.2 13.7 25.2 17.1 23.5 AAQ2 Project site at 34.8 55.3 44.4 54.2 14.6 22.8 18.1 22.2

AAQ3 Kenchenahallientrance 28.7 46.7 35.6 45.1 14.8 20.4 17.7 20.1 Location-1 AAQ4 Kenchenahalli 35.3 46.8 41.2 46.3 11.6 15.9 13.5 15.3 AAQ5 DoddanapalyaLocation -2 38.7 50.2 44.6 49.7 13.6 18.1 16.1 17.7 Location -1 AAQ6 Doddanapalya 34.8 45.7 40.9 45.2 15.4 19.5 17.2 19.5 Location 2 Thimmarajanahalli AAQ7 33.6 46.4 40.4 45.8 14.1 18.2 16.9 18.1

AAQ8 Kempanadodendri 37.9 48.7 41.9 46.9 13.9 18.4 16.3 18.0

Range 28.7- 59.7 11.6-25.2

Code Location SO, NOx

Min Max Avg 98% Min Max Avo 98%

AAQ1 Project site 12.8 23.3 17.4 22.4 14.5 27.9 22.4 27.8

AAQ2 Project site at 12.7 20.9 16.8 20.5 19.2 23.8 20.8 23.3 entrance AAQ3 Kenchenahalli 11.5 16.0 13.9 15.6 14.9 23.6 17.6 21.5 Location-1

AAQ4 Kenchenahalli 11.2 19.2 16.0 18.9 16.6 20.7 184 20.7 Location -2

AAQ5 Doddanapalya 12.1 16.8 14.0 16.0 16.0 22.1 19.1 21.9 Location -1

AAQ6 Doddanapalya 13.8 18.2 16.9 18.2 18.1 21.8 19.7 21.2 Location 2

167

Thimmarajanahalli AAQ7 12.4 20.9 17.9 20.8 16.6 25.5 22.2 25.5

AAQ8 Kempanadodendri 13.1 18.3 15.1 17.8 17.2 22.4 19.1 21.4

Range 11.2 23.3 14.5 27.9

Code Location CO 03 Min Max Avg 98% MM Max Avg 98%

AAQ1 Project site 398 660 511 649 3.9 8.6 5.8 8.3

AAQ2 Project site at entrance 408 552 455 532 4.1 6.8 5.5 6.6 AAQ3 Kenchenahalli 397 541 448 521 3.1 6.9 5.4 6.8 Location-1 MQ4 Kenchenahalli 437 499 475 498 3.1 6.9 5.4 6.8 Location -2 AAQ5 Doddanapalya 429 662 536 655 3.7 8.2 5.6 8.1 Location -1 AAQ6 Doddanapalya 445 625 482 607 3.1 8.3 4.5 6.8 AAQ7 ThimmarajanahalliLocation 2 371 624 486 617 3.6 8.8 5.5 8.6 AAQ8 Kempanadodendri 443 638 541 635 4.1 8.0 5.7 7.8

Range 371 662 3.14.8

Code Location MC VOC

Min Max Avg 98% Min Max Avg 98%

AAQ1 Project site 498 753 591 742 <0.001 <0.001 <0.001 <0.001

AAQ2 Project site at 505 746 594 738 <0.001 <0.001 <0.001 <0.001 entrance AAQ3 Kenchenahalli 439 603 506 598 <0.001 <0.001 <0.001 <0.001 Location-1 AAQ4 Kenchenahalli 439 540 504 539 <0.001 <0.001 <0.001 <0.001 Location -2 AAQ5 Doddanapalya 460 625 531 620 <0.001 <0.001 <0.001 <0.001 Location -1

168

AAQ6 Doddanapalya Location 2 418 565 488 563 <0.001 <0.001 <0.001 <0.001

AAQ7 Thimmarajanahalli 460 655 536 644 <0.001 <0.001 <0.001 <0.001

AAQ8 Kempanadodendri 475 680 553 676 <0.001 <0.001 <0.001 <0.001

Range 418 753 <0.001

4.6.4. NOISE LEVEL SURVEY

The physical description of sound concerns its loudness as a function of frequency. Noise in general is sound, which is composed of many frequency components of various types of loudness levels distributed over the audible frequency range. The most common and universally accepted scale is the A weighted scale, which is measured as dB (A). This is more suitable for audible range of 20 to 20,000 Hz. The scale has been designed to weigh various components of noise according to the response of human ear. The environmental impact of noise can have several effects varying from Noise Induced Hearing Loss (NIHL) to annoyance depending on loudness of noise.

The impact of noise sources on surrounding community depends on:

• Characteristics of noise sources (instantaneous, intermittent or continuous in nature). It can be observed that steady noise is not as annoying as one which is continuously varying in loudness; • The time of day at which noise occurs, for example high noise levels at night in residential areas are not acceptable because of sleep disturbance; and • The location of the noise source, with respect to noise sensitive landuse, which determines the loudness and period of exposure. The environmental impact assessment of noise from the construction activity, and vehicular traffic can be undertaken by taking into consideration various factors like potential damage to hearing, physiological responses, annoyance and general community responses.

Noise survey has been conducted in the study area while covering three zones viz., residential, commercial and silence zones. Noise monitoring has been undertaken for 24 hr at each location. 169

The main objective of noise monitoring in the study area is to establish the baseline noise level and assess the impact of the total noise generated by the proposed plant.

Method of Monitoring Sound Pressure Levels (SPL) measurements were recorded at eight locations. The readings were taken for every hour for 24 hrs. The day noise levels have been monitored during 6 am to 10 pm and night noise levels during 10 pm to 6 am at all the locations covered in the study area.

During each hour parameters like L10, L50, L90 and Leq were directly computed by the instrument based on the sound pressure levels.

Identification of Sampling Locations A preliminary reconnaissance survey has been undertaken to identify the major noise generating sources in the area. Noise at different noise generating sources has been identified based on the activities in the village area, ambient noise due to industries and traffic and the noise at sensitive areas like hospitals and schools. The noise monitoring was conducted during the study period for determination of noise levels at eight locations in the study area. The noise levels at each location were recorded for 24 hours.

DETAILS OF NOISE MONITORING LOCATIONS

Station Code Name of the Station Distance wrt plant Direction boundary (km) N 1 Project site -- --

N2 Kenchenahalli 4.1 km NE

N3 Doddanapalya 3.5 km SE

N4 Thimmarajanahalli 4.1 km SW

N 5 Kempanadodendri 4.6 km SE

170

Presentation of Results Sr. no Location L10 L50 L90 Leq Lday Lnight Ldn

N 1 Project site 52.1 48.4 44.8 49.3 50.0 43.7 53.8

N2 Vasanthnarasapura 48.4 44.5 40.7 45.5 47.4 41.5 50.2

N3 Doddanapalya 45.3 41.5 38.0 42.4 43.0 40.0 47.0

N4 Thimmarajanahalli 46.8 43.2 39.5 44.1 44.6 40.6 47.9

N 5 Chikkenahalli 49.8 45.9 42.1 46.9 47.9 41.0 51.2

Area Code Ambient Noise Standards Category of the Noise Levels(dB(A)Leq(Limits) Area Day time Night Night A Industrial Area 75 70 B Commercial Area 65 55 C Residential Area 55 45 D Silence Zone 50 40 Source : Ambiant Noise Standards of CPCB

a) Daytime Noise Levels (Lday)

The daytime noise levels in the study area ranged between 43.0-50.0 dB (A). It is observed that the day time noise levels at residential locations are within the prescribed limit of 55 dB (A). b) Night time Noise Levels (Lnight)

The night time noise levels in the study area ranged between 40.0-43.7 dB (A). It is observed that the night time noise levels at residential locations are not exceeding the prescribed limit of 45 dB (A).

4.6.5. BIOLOGICAL ENVIRONMENT Introduction An ecological survey of the study area was conducted, particularly with reference to listing of species and assessment of the existing baseline ecological (Terrestrial and Aquatic ecosystem) conditions in the study area. Considering the rich biodiversity of organisms and their role in productivity and their importance for human livelihood, it is vital to protect and 171

safeguard these dynamic ecosystems. The present report gives the review of published secondary data. Objectives and Methodology The present study was undertaken with following objectives:  To assess the nature and distribution of vegetation in and around the existing project site;

 To assess the distribution of animal life spectra;

 To assess the biodiversity and to understand the resource potential

To achieve the above objectives a study of the area was undertaken with the project site as its centre. The different methods adopted were as follows: Compilation of secondary data with respect to the study area from published literature and Government agencies;

Discussion with local people so as to elicit information about local plants, animals and their uses.

4.6.6. SOCIO-ECONOMIC ENVIRONMENT

The study of socio-economic component of environment incorporating various facets related to socio-economic conditions in the area forms an integral part of EIA process. The study includes demographic structure, population dynamics, infrastructure, resources and economic attributes refers to employment, industrial development and financial sustainability of the project.

The aesthetic environment refers to scenic value of the area, tourist attraction, forest and wild life, historic and cultural monuments.

Demography and societal status The information on present status of the human settlements was collected from the secondary sources such as census book and concerned government departments. The baseline status refers to:

1. Demography structure

2. Infrastructure resource and

3. Economic attributes

172

The study area falls under Tumkur area limits. Besides the study area covers both urban settlements and rural region.

The proposed project is Modification and expansion in product of drug manufacturing & intermediates in the premises; capacity enhancement of existing product and addition of new drug products for API manufacturing; which is located at Plot no.191-A, KIADB Industrial area 1st stage, Vasanthanarasapura, Kora Hobli, Tumkur tq. and dist.- 572128

According to the 2011 census Tumakuru district has a population of 2,678,980, roughly equal to the nation of Kuwait or the US state of Nevada. According to this census, 24,13,812 are Hindus (90.10%), 2,45,923 are Muslims (9.18%) 9130 are Christians (0.34%), 5067(0.19%) are Jains. This gives it a ranking of 150th in India (out of a total of 640). The district ranked 4th place in terms of population in Karnataka after Bengaluru, Belgaum and Mysore. The district has a population density of 253 per square km. Its population growth rate over the decade 2001-2011 was 3.74%. Tumakuru has a sex ratio of 984 females for every 1000 males, and a literacy rate of 75.14%.

173

174

4.7. SOCIAL INFRASTRUCTURE AAVAILABLE:

Due to proposed project activity Social Infrastructure will improve by means of Civilization, standard of living, education, Vocational Training, and Basic Amenities. Additional benefits will be arrived from the proposed project like: residential apartment, healthcare, educational facilities to the community, community hall, sports centre’s, recreational centers, industrial developments, shopping malls, public services in the surrounding area

Better education facilities, proper health care, road infrastructure and drinking water facilities are basic social amenities for better working standard of human being. Proposed project will further increase the above amenities directly/indirectly either by providing or by improving the existing facilities in the area, which will help in uplifting the living standards of local communities. Due to this project development adaptation of new technologies and other infrastructural facilities will improve which will indirectly boost the civilization of the surrounding people. The project is going to have positive impact on consumption behavior by way of raising average consumption and income through multiplier effect. The following change in socio-economic status is expected to take place with this project.

. Education facilities . Banking facilities . Post offices and communication facilities . Medical facilities . Recre ational facilities . Business establishment

175

CHAPTER 5 PLANNING BRIEF

5.1. PLANNING CONCEPT:

The total site area of the proposed project including the existing facility 19523 sq.m

The detailed area details as follows

Total plot area 19523 sq.m

Ground coverage area 1717 sq.m

Existing + expansion 7000 sq.m Phase 2 Open area- parking, paving, roads etc. 5000 sq.m

Landscape area 5800 sq.m

The Expansion phase area details

Nature of the product Construction area Plot area utilization 1. To manufacture 7000 sq.ft of pilot plant (first No change in land area products by rDNA floor of existing block) utilization technology 2. To manufacture 4000 sq.ft of basement floor No change in land area biological products using utilization solvent extraction

The overall facilities proposed under the project broadly consist of the following elements/operations;  Plant and Machinery & Utilities  Production units  Safety and Pollution control facilities associated with the production of the above.  Supporting services such as Boiler and for DG sets utilities

176

5.2. POPULATION PROJECTION:

COMPARATIVE SIZE OF POPULATION OF DISTRICTS 2011

Description 2011 2001

Actual Population 2,678,980 2,584,711

Male 1,350,594 1,313,801

Female 1,328,386 1,270,910

Population Growth 3.65% 12.10%

Area Sq. Km 10,597 10,597

Density/km2 253 244

Proportion to Karnataka 4.38% 4.89% Population

Sex Ratio (Per 1000) 984 967

Child Sex Ratio (0-6 Age) 959 949

Average Literacy 75.14 67.01

Male Literacy 82.81 76.78

Female Literacy 67.38 56.94

Total Child Population (0-6 Age) 265,742 308,162

Male Population (0-6 Age) 135,671 158,079

Female Population (0-6 Age) 130,071 150,083

Literates 1,813,391 1,525,485

177

Male Literates 1,006,024 887,341

Female Literates 807,367 638,144

Child Proportion (0-6 Age) 9.92% 11.92%

Boys Proportion (0-6 Age) 10.05% 12.03%

Girls Proportion (0-6 Age) 9.79% 11.81%

5.3. LAND USE PLANNING:

Vegetation is the natural extension of the soil ecosystem on a site. It can provide summer shade, wind protection, and a low-maintenance landscape that is adapted to the local environment. Unfortunately, the common practice is to remove the existing landscape cover and replace with a generic, water and maintenance-intensive lawn. It is proposed to develop a minimum 30% of the total site area as greenbelt area which amounts to about 5800 m2 of total site area, as the total site area of the project is 19,523 sq.m

30% of total plot area has been earmarked for developing green belt all along the boundary.  Avenue trees will also be raised along the road side.  Necessary landscaping will be done to enhance the aesthetic view of the unit.  Native trees will be planted where ever required.

178

LIST OF TREE SPECIES

Large Size Trees: Common Name

Anthocephaluscadamba Kadwal/Bale/Kadamba

Azadarichtaindica Neem / Beveeniamara

Ficusinfectoria / virens Karibasuri/Basari

Pterospermumacerifolium Muchkund/kanakChampa

Mimusopselengi Pokkalathu

Saracaindica Asoka/Ashunkar

Tamarindusindica Hunshemara

Fruit Bearing Trees: Common Name

Aeglemarmelos Bilvapatre

Artocarpusintegrifolia Alasa/Halasu/Gujja/Panasero

Embelicaofficinalis Nelli/Dadi/Dhanya

Eugenia jambolana Narala, Nerula, Neeram

Moringaoleifera Nugge/drumstick tree

Ficuscarica Anjura/Simeyatti

Medium Size Trees: Common Name

Averrhoacarambola Komarakmara

Bauhinia variegate Kanchivalado

179

Buteamonosperma Muttuga

Cassia nodosa Pink Mohur

Cassia renigera Pink cassia

Erythrinaindica Ippi/Allipe

Lagerstroemia flos-reginae Challa

Madhucaindica Ippi/Allipe

Micheliachampaka Sampige

Millingtoniahortensis Beratu/Biratumara

Phyllanthusemblica Nelli/Dadi/Dhanya

Pongamiaglabra Honge/Hungay

RAIN WATER HARVESTING Typical rain water recharge structures as below will be constructed in the propose site to harvest the rain water & to maintain the storm drainage from the proposed site.

180

Figure: Details of rain water recharge pit with bore hole with dimensions.

181

Figure: Details of rain water recharge trench pit with dimensions.

The Volume of rain water available from the paved & open region will be around 60 cum & hence adequate nos. of recharge pit & trench with above dimensions will be constructed at the site for effective storm water management.

5.4. ASSESSMENT OF INFRASTRUCTURE DEMAND

Project benefit focused on those points which become beneficial to the surrounding area or community in terms of infrastructural development, social development, boosting employment and other tangible benefits due to upcoming or proposed activities in form side benefits.

The upcoming proposed expansion project will bring overall improvements in the locality, neighborhood and to the state by bringing industry, roads, water supply, drainage facility, power supply, employment for skilled, semi skilled and unskilled labour, thereby uplifting the living standards of local communities and economic growth as well as it also stimulates the growth in small and medium scale industries like residential developments, hotels, shopping complexes, retail shops, health centre’s, educational institutes, recreational centers etc., may be further developed as a consequence.

5.4.1. IMPROVEMENT IN PHYSICAL INFRASTRUCTURE The proposed expansion project is expected to yield a positive impact on the socio- economic environment. It helps in sustainable development of this area including further development of physical infrastructural facilities. The following physical infrastructure facilities will improve due to proposed project:  Road transport facilities  Water supply and sanitation

5.4.2. IMPROVEMENT IN SOCIAL INFRASTRUCTURE Due to proposed project activity Social Infrastructure will improve by means of Civilization, standard of living, education, Vocational Training, and Basic Amenities. Additional benefits will be arrived from the proposed project like: residential apartment, healthcare, educational facilities to the community, community hall, sports centre’s, recreational centers, industrial developments, shopping malls, public services in the surrounding area 182

Better education facilities, proper health care, road infrastructure and drinking water facilities are basic social amenities for better working standard of human being. Proposed project will further increase the above amenities directly/indirectly either by providing or by improving the existing facilities in the area, which will help in uplifting the living standards of local communities. Due to this project development adaptation of new technologies and other infrastructural facilities will improve which will indirectly boost the civilization of the surrounding people. The project is going to have positive impact on consumption behavior by way of raising average consumption and income through multiplier effect. The following change in socio-economic status is expected to take place with this project.

. Education facilities . Banking facilities . Post offices and communication facilities . Medical facilities . Recreational facil ities . Business establishment

5.5. FACILITIES: The proposed project is likely to have other tangible benefits as given below  Indirect employment opportunities to local people in contractual works like housing construction, transportations, sanitation, for supply of goods and services to that project and other community services  Additional housing demand for rental accommodation will increases  Market and bossiness establishment facilities will also increase  Cultural, recreation and aesthetic facilities will also improve  Improvement in communication, transport, education, community development and medical facilities  The project will contribute additional revenue to the state and central exchequer in the form different kind of taxes .

183

CHAPTER 6

PROPOSED INFRASTRUCTURE

Samarth Life Sciences Private Limited proposes to produce 12 number of Active Pharmaceutical Ingredients (API’s) products of Therapeutic category and 12 number of all the products will be manufactured on a batch basis per day. The products arecategories in process or therapeutic usage

Available infrastructure consideration in the selection of site are as detailed below,

• Availability of infrastructure facilities such as State Highway road access to the proposed project site for ease of transportation of workforce, plant equipment and fuel etc., • Availability of facilities like medical, education, civic amenities and railway station within reasonable distance from the site.

6.1. AREA

Total plot area 19523 sq.m

Ground coverage area 1717 sq.m

Existing + expansion 7000 sq.m Phase 2 Open area- parking, paving, roads etc. 5000 sq.m

Landscape area 5800 sq.m

6.2. GREEN BELT

The Tree Plantation is one of the effective remedial measures to control the air pollution and Noise pollution. It also causes aesthetics and climatologically improvement of area as well as sustains and supports the biosphere. It is an established fact that the trees and vegetation acts as a vast natural sink for the gaseous as well as particulate air pollutants. Due to enormous surface area of the leaves, it also helps to attenuate the ambient noise level. The plantation around the pollution sources control the air pollution by filtering the air pollutant and interact with gaseous pollutant before it reaches to the ground. The tree plantation also acts as buffer

184

and absorber against accidental release of pollutants. The selection of tree species suitable for plantation at the industry shall be governed by guiding factors as stated below.

 The tree shall tolerant to air pollutants present in the area  The tree is able to grow and thrive on the soil of the area, be evergreen, inhabitant, having minimum of leaf fall.  The tree is tall in peripheral curtain plantation and with large and spreading canopy in primary and secondary attenuation zone.  The tree posse’s extensive foliar area to provide maximum impinging surface for continued efficient adsorption and absorption of pollutants.  The tree are fast growing and indigenous, and shall maintain ecological, land and hydrological balance of the region.

6.3. SOCIAL INFRASTRUCTURE

Due to proposed project activity Social Infrastructure will improve by means of Civilization, standard of living, education, Vocational Training, and Basic Amenities. Additional benefits will be arrived from the proposed project like: residential apartment, healthcare, educational facilities to the community, community hall, sports centre’s, recreational centers, industrial developments, shopping malls, public services in the surrounding area

Better education facilities, proper health care, road infrastructure and drinking water facilities are basic social amenities for better working standard of human being. Proposed project will further increase the above amenities directly/indirectly either by providing or by improving the existing facilities in the area, which will help in uplifting the living standards of local communities. Due to this project development adaptation of new technologies and other infrastructural facilities will improve which will indirectly boost the civilization of the surrounding people. The project is going to have positive impact on consumption behavior by way of raising average consumption and income through multiplier effect. The following change in socio-economic status is expected to take place with this project.

. Education facilities . Banking facilities . Post offices and communication facilities . Medical facilities

185

. Recreational facilities . Business establishmen t

6.4. CONNECTIVITY:

Sl. Particulars Details No. 1 Plant site coordinates Latitude : 13.492385, Longitude: 77.026576

2 Plant Site Elevation 900 mtr above MSL

3 Nearest Highway NH-4

4 Nearest Railway Station Tumkur Railway Station 17.4 Km

5 Nearest Airport Kempegowda International Airport – 106 Km

6 Nearest village Vasanthanarasapura – 900 mtr

Thimmarajanahalli -2.2 Km

7 Nearest major city Tumkur 17 Km

9 Nearest water bodies Kaggere Lake – 8.01 Km Hebbaka Reservoir- 8.09 Km 10 Nearest major hill range Devarayanadurga hills – 30.8 Km Shivaganga hills – 42.6 Km

6.5. DRINKING WATER MANAGEMENT:

WATER SOURCE – BOREWELL

Water consumption Consumption (L/day) Discharge (L/day) purpose API Rec. Total API Block Rec. Block Total Block Block 1. Domestic (toilet, 500 500 1000 400 400 800 canteen etc.)

2. Gardening/ 5000 - 5000 - - - Landscaping

186

a. Process 700 950 1650 650 900 1550 b. Washing 400 450 850 400 400 800 /cleaning 4. QC/ R&D 500 - 500 500 - 500 5. DM/ Softener 500 500 1000 500 500 1000 rejects

Total 8700 3800 12500 3500 3550 7050

6.6. INDUSTRAL WASTE MANAGEMENT

Effluent source Treatment mechanism Final disposal point

3. Domestic - Discharged to Septic tank and Soak pits

4. Industrial Storage tank- Industrial effluent will be sent to Existing capacity : 30KL X 2 Common Effluent treatment plant Proposed capacity (CETP)- M/s. Govind Solvents Pvt. addition: 30KL X 3 Ltd., for treatment and disposal

EFFLUENT TREATMENT FACILITY AT CETP

Name of CETP provider M/s. Govind solvents Pvt. Ltd., No.19(P)-22, Kunigal Industrial area, Kunigal tq., Tumkur- dist.

Distance from the project site ~ 40 Kms Mode of transport Tanker by CETP provider

6.7. SOLID AND HAZARDOUS WASTE MANAGEMENT: All the wastes generated ranging from the most inert to the most toxic, shall be collected and managed in a scientific manner as mentioned in the above tables. A waste tracking system will be developed and maintained to keep a record of the types and quantities of waste present at the job sites. This record shall be used to monitor the effectiveness of the waste management program. All disposals will meet manifest system and relevant regulatory 187

norms of the Karnataka State Pollution Control Board and the Ministry of Environment and Forests.

SOLID WASTE GENERATION AND HANDLING:

Source of solid Treatment mechanism Final disposal point waste

1. Domestic 20 kgs/day (Including canteen Waste will be disposed of at a site as waste) approved by local authority.

2. Industrial Storage tank- Hazardous waste is proposed to be sent to process Existing capacity : 200Kgs Common Solid Waste Treatment Plant Proposed capacity (CSWTP) of M/s Bangalore Incinerators addition: 200Kgs Pvt. Ltd., for treatment and disposal

HAZARDOUS WASTE GENERATION

Cat. Type Category Quantity Method of handling No. /disposal

01 Used Oil 5.1 0.2 KL/year Shall be collected

02 Oil & chemical 5.2 500 kgs/year Handed over to M/s Bangalore contaminated Incinerators Pvt. Ltd., for cotton waste treatment and disposal

03 Residue/chemical 33.3 100 nos Handed over to KSPCB containers authorized recycler

188

HAZARDOUS WASTE TREATMENT FACILITY AT CETP

Name of CSWTP 1. M/s. Bangalore Incinerators Pvt. Ltd. provider No.28, KIADB Industrial area, Kunigal- tq, Tumkur-dist. 2. M/s. Medicare Pvt. Ltd., Dabaspet, Bangalore- dist Distance from the project ~ 40 Kms site Mode of transport by CSWTP provider

BIOMEDICAL WASTE TO BE GENERATED DURING OPERATION PHASE OF THE PROJECT

Sl. No Type Quantity Method of Handling /disposal

01 General biomedical Handed over to KSPCB authorized waste from R&D incinerator

6.8. POWER REQUIREMENT:

Power demand during operation phase is estimated to be around 55 kVA. The supply of power would be met through BESCOM supply. The power supply would be through 66 kV, 2500 MVA, 21.86 kA, 50 Hz, Solidly Earthling system. The variation for voltage and frequency shall be: High Voltage: 66kV + 10% Low Voltage: 400 V + 10% Frequency: 50 Hz + 3%

Outdoor installation will be through a 66 kV overhead HT line with switch yard accessories. Metering would be provided by BESCOM in 66 kV switch yard. Sub-station would be located at boundary of the Project site. Power supply from BESCOM will be used for office and other utility system.

Diesel generators of 60 kVA will be provided as source for power backup arrangement 189

CHAPTER 7

REHABILITATION AND RESETTLEMENT (R&RPLAN)

The Tree Plantation is one of the effective remedial measures to control the air pollution and Noise pollution. It also causes aesthetics and climatologically improvement of area as well as sustains and supports the biosphere. It is an established fact that the trees and vegetation acts as a vast natural sink for the gaseous as well as particulate air pollutants. Due to enormous surface area of the leaves, it also helps to attenuate the ambient noise level. The plantation around the pollution sources control the air pollution by filtering the air pollutant and interact with gaseous pollutant before it reaches to the ground. The tree plantation also acts as buffer and absorber against accidental release of pollutants. The selection of tree species suitable for plantation at the industry shall be governed by guiding factors as stated below.

 The tree shall tolerant to air pollutants present in the area  The tree is able to grow and thrive on the soil of the area, be evergreen, inhabitant, having minimum of leaf fall.  The tree is tall in peripheral curtain plantation and with large and spreading canopy in primary and secondary attenuation zone.  The tree posse’s extensive foliar area to provide maximum impinging surface for continued efficient adsorption and absorption of pollutants.  The tree are fast growing and indigenous, and shall maintain ecological, land and hydrological balance of the region. The proposed project is likely to have other tangible benefits as given below  Indirect employment opportunities to local people in contractual works like housing construction, transportations, sanitation, for supply of goods and services to that project and other community services  Additional housing demand for rental accommodation will increases  Market and bossiness establishment facilities will also increase  Cultural, recreation and aesthetic facilities will also improve  Improvement in communication, transport, education, community development and medical facilities  The project will contribute additional revenue to the state and central exchequer in the form different kind of taxes .

Due to proposed project activity Social Infrastructure will improve by means of Civilization, standard of living, education, Vocational Training, and Basic Amenities. Additional benefits 190

will be arrived from the proposed project like: residential apartment, healthcare, educational facilities to the community, community hall, sports centre’s, recreational centers, industrial developments, shopping malls, public services in the surrounding area

Better education facilities, proper health care, road infrastructure and drinking water facilities are basic social amenities for better working standard of human being. Proposed project will further increase the above amenities directly/indirectly either by providing or by improving the existing facilities in the area, which will help in uplifting the living standards of local communities. Due to this project development adaptation of new technologies and other infrastructural facilities will improve which will indirectly boost the civilization of the surrounding people. The project is going to have positive impact on consumption behavior by way of raising average consumption and income through multiplier effect. The following change in socio-economic status is expected to take place with this project.

. Education facilities . Banking facilities . Post offices and communication facilities . Medical facilities . Recreational facilities . Business establishment

191

CHAPTER 8

PROJECT SHEDULE AND CST ESTIMATES

PROJECT COST

There is an additional project cost as it is a proposed expansion unit. Cost of the project for expansion and modification is Rs. 20 Crores. The details are listed in the table below.

Project is likely to start once we get the approval from environmental clearance.

Samarth Life Sciences Private Limited proposes to produce 12 number of Active Pharmaceutical Ingredients (API’s) products of Therapeutic category and 12 number of all the products will be manufactured on a batch basis per day. The products arecategories in process or therapeutic usage.

The total site area of the proposed project including the existing facility 19523 sq.m

The detailed area details as follows

Total plot area 19523 sq.m

Ground coverage area 1717 sq.m

Existing + expansion 7000 sq.m Phase 2 Open area- parking, paving, roads etc. 5000 sq.m

Landscape area 5800 sq.m

The Expansion phase area details

Nature of the product Construction area Plot area utilization 1. To manufacture 7000 sq.ft of pilot plant (first No change in land area products by rDNA floor of existing block) utilization technology 2. To manufacture 4000 sq.ft of basement floor No change in land area biological products using utilization solvent extraction

192

CHAPTER 9 ANALYSIS OF PROPOSAL

The proposed expansion project is expected to yield a positive impact on the socio-economic environment. It helps in sustainable development of this area including further development of physical infrastructural facilities. The following physical infrastructure facilities will improve due to proposed project:  Road transport facilities  Water supply and sanitation

9.1. SOCIAL BENEFITS:

Due to proposed project activity Social Infrastructure will improve by means of Civilization, standard of living, education, Vocational Training, and Basic Amenities. Additional benefits will be arrived from the proposed project like: residential apartment, healthcare, educational facilities to the community, community hall, sports centre’s, recreational centers, industrial developments, shopping malls, public services in the surrounding area

Better education facilities, proper health care, road infrastructure and drinking water facilities are basic social amenities for better working standard of human being. Proposed project will further increase the above amenities directly/indirectly either by providing or by improving the existing facilities in the area, which will help in uplifting the living standards of local communities. Due to this project development adaptation of new technologies and other infrastructural facilities will improve which will indirectly boost the civilization of the surrounding people. The project is going to have positive impact on consumption behavior by way of raising average consumption and income through multiplier effect. The following change in socio-economic status is expected to take place with this project.

. Education facilities . Banking facilities . Post offices and communication facilities . Medical facilities . Recreational facilities . Business establishment

193

9.2. OTHER BENEFITS:

The proposed project is likely to have other tangible benefits as given below  Indirect employment opportunities to local people in contractual works like housing construction, transportations, sanitation, for supply of goods and services to that project and other community services  Additional housing demand for rental accommodation will increases  Market and bossiness establishment facilities will also increase  Cultural, recreation and aesthetic facilities will also improve  Improvement in communication, transport, education, community development and medical facilities  The project will contribute additional revenue to the state and central exchequer in the form different kind of taxes .

194