In Order to Meet Your Requirements and Provide You with a Quotation, We Would Be Grate

CO AC 4 505

GROWTH MEDIA STERILIZER

Contact: Carlyle CONN Contact: Philippe MIRA P - +1.814.362.2590 ext.322 T - 33(0) 450 83 12 12 F - +1.814.362.2574 F - 33(0) 450 83 12 10 E - [email protected] E - [email protected] Page 1/5

In order to meet your requirements and provide you with a quotation, we would be grateful if you could answer to the following questions. If you are interested in Liquid Biowaste decontamination or Embryo eggs Biowaste Decontamination, other questionnaires are available: CO AC 4 504 - Questionnaire - Liquid Biowaste Decontamination - ABC ACTINI CO AC 4 506 - Questionnaire - Embryo Eggs Biowaste Decontamination - ABC ACTINI

Many thanks.

COMPANY: Project Ref: Location: Date for the delivery of a quote: Estimated completion of the facility: Name of the contact:

GROWTH MEDIA STERILIZE

Maximal capacity of the sterilizer (contractual data): VERY IMPORTANT

Constant flow rate: Nominal production flow rate:

Variable flow:  Nominal production flow rate (l/h):  Maximal flow rate (l/h):  Minimal flow rate (l/h):

Knowledge of the Product:  Viscosity at 20°C in cp:  Viscosity at 95°C in cp:  Product sensitive above (°C): If you have other data at your disposal, please be kind to give us the temperatures and associated viscosities of the more viscous product of you product line.

Treatment scheme (*)  Required F0: : or Required Time: Required Temperature:  Process at constant F0 on variable flow rate? Yes No  Inlet temperature (°C):  Max. treatment temperature (°C):  Max. holding time (s):  Required outlet temperature (°C): * for the product with the above-mentioned characteristics. This case has to be the more restricting one for your production; it will allow to design the equipment

GMS – ABC ACTINI – REV1 CO AC 4 505

Installation:  Enclosed room  Non-enclosed room  Classification:  Clean room

Cleaning in Place :  Existing CIP? Yes No  To quote? Yes No

Energies available on site:  Steam: Flow rate: Pressure:  Overheating water: Flow rate:  Electricity: Power: Voltage:  Cooling water: Flow rate: Temperature:  Softened water: Flow rate: Temperature:  Demineralised water Flow rate: Temperature:  Compressed air Flow rate: Pressure:

Construction:  Presence of chloride in the product: No Yes Concentration: (Information required to choose the type of stainless steel)

 Required finishing for the stainless steel in contact with the product? - Without restraint: Ra 3,2 µ (Ra: 125 µ-inches) - Other: It’s compulsory to clarify the documentary aspect if an electro-burnishing is applied.

 Raw finishing certification: - Issued by an external company: Extra cost will be charged for each element. - Issued by ABC ACTINI free of charge.

- 3.1.B (Extra cost for each component) - 2.2 (free of charge)

 Welding control (percentage to precise) - Visual 20% 100% - Endoscopy with: photo video 20% 100% - Test with water under pressure: (less expensive than other controls) - Radiography 20% 100% - Dye penetrant test 20% 100% - Welding file to provide? Yes No - For what part of the process : - Percentage : %

Instrumentation:  Type of the flowmeter: - Electromagnetic flowmeter - Mass flowmeter (in case of demineralised water)

 Required Raw finishing certification: Yes No - 3.1.B (Extra cost for each component) - 2.2 (free of charge)

Automation: PLC or SCC (centralized control system) supplied by others

Our standards:  SIEMENS S 7  ALLEN BRADLEY Control Logix

 PLC located: on the skid somewhere else  Information to forward to the supervisor PLC or to the Building Management System If yes: - Interactive mode - 0/1 information - Exchange table - Communication network type:  Functional Analysis according to S88 Yes No

Equipment qualifications and documentation :  Complete pharmaceutical Documentation  Assistance to the qualifications  IQ (Installation Qualifications)  OQ (Operating Qualifications)  PQ (Performance Qualifications)

Pricing basis to take into consideration: IQ + OQ + PQ = 20% to 30% of the budget The assistance consists in producing FAT and SAT tests and protocols, together with the machine documentation to help to the equipment qualification.

Items to include in our quotation:  Shipment and insurance Yes No  Unloading Yes No  Installation Yes No

N.B: We do not usually supply the energy connection and piping.

Available space in the room:  Length (mm):  Width (mm):  Height (mm):

Description of the process :

Comments :

GMS – ABC ACTINI – REV1