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Tetrahedron Laboratofies Private Limited MANUFACTURERS of API Tetrahedron Laboratofies Private Limited MANUFACTURERS OF API. INTERMEDIATE ANo.i'LlIEO PRODUCTS .. Telefax: +91-22-25342435 Registered Office: ~ Email: [email protected] 201-A, Harmony. Netaji Subhash Chandra Bos9 Road, ' Thane (W), 400601. Maharashtra. India. Website: www.tetrahedronJabs.com Date: 23.06.2018 To, The Member Secretary (IndU3Uy 11), Ministry of Environment, Forests and Climate Change, Indh'a PL,.,-aVAran BhawaD, Jor Bagh Roat'lt New De1hi~11000s Refwence: MOM Of 37th Expert Appraisal Committee [lndustry-z] Meeting held on so- May 2018. Subject: Submission of MoM Compliance for Environmental Clearance for proposed "'ManuJacturi:ng of Bulk f)rugs, Intermediates &. AlHf!d Products" at Plot No. F-2~, Mfnc Chind-uii1, 'if4h1kR:Mono1, nlt;trlct: SotApUf, Maharashtra. India by MIs.. Tetmhedro!l Lahomtoriea Pvt. Ltd.. Dear Sir, This is with reference to the above subject and reference, We, Mis. Tetrahedron Laboratories Pvt. Ltd., are proposing for flMonufa.cturing of Bulk Drugs, Intermediates &. A11iedProducts" at Plot No. F 25, M11)C Chincho1i, 1'iJ1ulm:Mohol, nistrict: Solupur. Maharashtra, India. and submitted EIAReport online on dated 13.01.2018. In this connection, MoRF &. ce, New DeJhi hRd con kkred our case in 37th :IT.pe.. rt Appraisal Committee (lndustry-z] meeting on 30/05/2018 stating that ~The EACj after ddibe ticn~, ob:~ discre ei potiDJly l"esl'em of the di«~nt uuburtrUd l'~!G uti l.1'1~tlMd.Dut; to th.at, it Wg not possible to UDdGl'Stand the po11UtJoB COBcema aDd/or the impact or the project 011 different &avirontneatal puametera. The- Comm!~ also desired for-presence of the EtA ~tor for taUon of the pl'(J~". In this connection, the pointwise compliance of the above mentioned MOM is as follows! 1) The EAC, .~ deHberatlou., o&.erved 4~PQneie1; = t::h'e p~~l especially in respect oC the cUfferent bldustrlal processes Ioperations involved. Due to tha~ it was Dot possible to understand the pollution eeaceens and/or the. impa.ct oC the project on different environmental parameteR: The productwise Industrial processes / operations ie enclosed at Annexure I 2) T~ Comn1ittee ·dso d~d lot' pt'~ of the EL'i. ~~!Dator f01' presentation of the proposal: It is assure that EIA coordinator will be presenting the Case in the EAC meeting. 3} Hence, you are requested to kindly review our proposal and consider our case in next agenda, For: MIs. Tetrahedron Laboratories Pvt. Ltd. (Authorized SignAtory) ANNEXURE I Manufacturing Process 1. Cyano acetic acid Manufacturing Process: Water is charged in M.S. Rubber lined reactor. Sodium salt of Sodium Monochloro Acetate is charged. Sodium cyanide is added slowly & lot wise. After the completion of reaction the Sodium Salt of Cyano Acetic Acid is acidified with Sulphuric and this aqueous solution is extracted with MIBK (methyl iso butyl ketone) it is concentrated, cooled and centrifuged. Reaction: * Sodium salt of monochloro Acetate + Sodium Cyanide → Sodium Salt of Cyano Acetic Acid Cl−CH2−COONa + NaCN→ N≡C−CH2−COONa + NaCl * Sodium Salt of Cyano Acetic Acid + Sulphuric Acid → Cyano Acetic Acid N≡C−CH2−COONa + H2SO4 → N≡C−CH2−COOH + Na2SO4 Material Balance: Kg per Kg per Input Output batch batch Sodium Monochloro 2700 Product 1400 Acetate ANNEXURE I Water 6000 Liquid Effluent 10,042 Sodium Cyanide 1000 Solid Waste Carbon 08 Sulphuric Acid 1400 Solvent Losses 201.5 Solvent Recovery For Carbon 8 11600 Recycle Sodium Hydrosulphite 8 Ethylene Diamine Tetra 0.500 Acetic Acid Mono Iso Butyl Ketone 12050 Acetone 50 n-Hexane 35 Total 23251 - 23251 Process Flow Diagram: ANNEXURE I 2. Cyclohexanyle Acetonitrile (1-Cyclohexen-1-acitonitrite) Manufacturing process: In a SS reactor charge Cyano Acetic Acid. Add solvent Cyclohexanone and Ammonium Acetate at room temperature and heat the reaction to reflux and remove water by Azetrope. After complete removal water, maintain the reaction for 2 hrs. Fractionate the product by applying vaccum. Continuously give the sample to G.C. Till the product purity reaches to 98.5% after attaining its purity collect the main fraction and packed in 200 kegs HDPE drums. Reaction: * Cyclohexanone + Cyano Acitic Acid → Cyclohexanyle Acetonitrile C6H10O + C3H3O3N → C8H11N C6H10O + N≡C−CH2−COOH → C8H11N + H2O + CO2 Material Balance: Input Kg per Output Kg per batch batch Cyclohexanone 1648 Product-Main Fraction 1400 ANNEXURE I Cyano Acetic Acid 1428 Liquid Effluent Water 300 Ammonium Acetate 50 Distillation Loss 26.3 8-Hydroxy Quinoline 0.30 I-Fraction 1000 Soda Ash 45 Bottom Fraction 445 Total 3171.3 - 3171.3 Process Flow Diagram: 3. Caffiene Manufacturing process: Charge wet cake of Sodium Theophylline of stage II under stirring. Wet cake 756.0 Kgs. Start heating by steam through jacket Heat to 50oC-52oC. Charge hydrochloric acid from dozer T503 to adjust pH to 11.5-11.7. Cool to 35oCStart addition of dimethyl sulphate in 1 ½hrs. Keeping pH TP +ve by adding caustic soda lye in lots of ANNEXURE I one kg. Heat reaction mass to 85oC - 88oC Add 25Kgs. Act. Carbon Stir at 85oC – 88oC for one hour Filter the reaction mass in rector through the pp filter press to rector flush the line by air. Charge 300lts. DM water Heat to temp. 92oC-94oC Filter through pp filter press to rector Cool reaction mass in rector to 12oC-15oC. Centrifuge, spin dry wash each lot with 20lts. chilled ML of stage III from tank T509A Unload the wet cake in bags. Weigh & lable. Charge D.M.water 4.5 times the dry weight of crude Caffeine Charge wet cake of crude Caffeine of stage II under stirring. Start heating by steam through jacket heat to 82oC-84oC. Check pH. Check clarity of soln. Charge 40kgs. fresh act. Carbon Stir at 82oC-84oC for 1 hour. Filter the reaction mass in rector / 402B through the pp filter press to rector flush the line by air. Charge 200lts D.M.water. Heat to temp. 92oC-94oC Filter through pp filter press to rector Cool reaction mass in rector to RT by jacket cooling water & then to 12oC-15oC by chilled water. Centrifuge, spin dry wash each lot with 20lts. chilled DM Water from tank T509B unload the wet cake in bags. Weigh &lable. Charge the wet cake in FBD/ TD & dry at 85oC till LOD is < 0.5% Reaction: Reaction – from IIIrd stage ( Sodium Salt of Theophylline) Theophylline Sodium + Dimethyl Sulphate → Caffeine crude C7H7N4NaO2 + C2H6O4S → C8H10N4O2 ANNEXURE I Material Balance: Kg per Input Kg per batch Output batch Sodium Theophylline 800 Wet Cake ( Crude) 500 Water 2000 Solid Waste Carbon 10 Di-Methyl Sulphate 420 Liquid Effluent 2866 50% Caustic Solution 100 Product 500 Hydrochloric Acid 30% 16 Solid Waste Carbon 10 Activated Carbon 40 Liquid Effluent(ML) 2240 Water 2000 Wet Cake (Crude) 500 Activated Carbon 50 Water Washing 200 Total 6126.0 - 6126.0 Process Flow Diagram: SODIUM THEOPHYLLINE ANNEXURE I 4. Theophylline Manufacturing process: Charge wet cake of sodium Theophylline of stage II under stirring. Start heating by steam through jacket Heat to 92oC-94oC Charge hydrochloric acid from dozer T503 to adjust pH to 8.2-8.4 check clarity of soln. Charge 20kgs. Fresh act. Carbon Stir at 92oC -94oC for 1 hour Filter the reaction mass in rector through the pp filter press to rector flush the line by air. Charge 300lts. ML of stage III from T506A Heat to temp. 92oC-94oC Filter through PP Filter press to rector Charge 1.5kgs. Sod. Hydrosulphite Cool reaction mass in rector to 48oC-50oC. Adjust pH to 4.8-5.0 by hydrochloric acid at 48oC-50oC Stir at pH 4.8-5.0 & temp. 48oC-50oC. Cool to RT by jacket cooling water & then to 8oC-10oC by chilled water. Centrifuge, spin dry wash each lot with 20lts. chilled ML of stage III from tank T509A Unload the wet cake in bags. Weigh &lable. Check clean & Dry Rector rector Charge D.M.water 6.8 times the dry weight of crude Theophylline Charge wet cake of crude Theophylline of stage II under stirring. Start heating by steam through jacket heat to 92oC-94oC. Check pH. Check clarity of soln. Charge 40kgs. fresh act. Carbon Stir at 92oC-94oC for 1 hour Filter the reaction mass in rector through the pp filter press to rector flush the line by air. Charge 200lts D.M.water. Heat to temp. 92oC-94oCFilter through pp filter press to rector Charge0.5kgs. Sod Hydrosulphite Cool reaction mass in rector to RT by jacket cooling water & then to 8oC-10oC by chilled water. Centrifuge, spin dry wash each lot with 20lts. Chilled DM Water from tank T509B unload the wet cake in bags. Weigh &lable. Charge the wet cake in FBD/ TD & dry at 85oC till LOD is < 0.5%. Reaction: Reaction – from IIIrd stage (Sodium Salt of Theophylline) Theophylline Sodium + Hydrochloric Acid → Theophylline crude C7H7N4NaO2 + HCl → C7H8N4O2 + NaCl ANNEXURE I Material Balance: Kg per Input Kg per batch Output batch Sodium Theophylline 800 Wet Material(Crude) 500 Hydrochloric Acid 30% 500 Solid Waste(Carbon) 10 Activated Carbon 40 Effluent ML 2330 D.M. Water 1500 Product 500 Water 2000 Solid Waste 10 Wet Material (Crude) 500 Effluent ML 2030 Activated Carbon 40 Total 5380.0 5380.0 ANNEXURE I Process Flow Diagram: SODIUM THEOPHYLLINE 5. Theobromine Manufacturing process: Stage III: ABMU Check the rector it should be clean & ready to use. Charge DM water at room temperature & check pH. Charge AMU at RT & check pH. Charge Acetic Acid at RT & check pH. Cool the reaction mass to10-12ºC. Charge Bromine slowly between 10to 17ºC temperature & givesample to QC. Note:- Ensure that operator should wear safety Face shield, handgloves& mask. Rise the temperature 18to 21ºC & maintain the reaction for 2hrs ANNEXURE I Between18to 21ºC.
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