Questionnaire Pure Media Systems
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- Rosanna Pope
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1 1. PROJECT INFORMATION: Project Name: Client: Contact Person: Telephone / Fax N : 2. BASIC INFORMATION Type of Pure Media System PW / HPW - Generation PW / HPW - Storage & Distribution System Cold Water System Hot Water System WFI- Generation WFI- Storage & Distribution System Cold Water System Hot Water System Pure Steam Generation Pure Steam - Distribution System Please take note of further questionnaires for Pure Water generation, WFI Still and Pure Steam Generation Type of Sanitisation Procedures for PW / HPW- Storage & Distribution Sanitisation at 85 C Hot Water Sanitisation > 121 C Sanitisation by Ozone and UV Radiation Pure Steam Sterilisation Type of Sanitisation Procedures for WFI- Storage & Distribution Sanitisation at 85 C Hot Water Sanitisation > 121 C Pure Steam Sterilisation 1/7
2 3. DESIGN FEATURES Available Technical Information Available P+ID flow sheet Yes Available floor plan & lay out with points of use Yes Please add existing documents and complete the following form with information about consumption for each point of use (Amount, Flow Rate, Pressure, Position, Room Number) PW Master Detail Screen available WFI Master Detail Screen available Pure Steam Master Detail Screen available Miscellaneous (cold or hot Sub-Loops or other) Piping System (Hot) Piping Segment1 Length: m : Piping Segment 2 Length: m : Piping Segment 3 Length: m : Piping System (Cold) Piping Segment1 Length: m : Piping Segment 2 Length: m : Piping Segment 3 Length: m : Pure Steam Pipe System Length: m : 2/7
3 4. TRANSPORT AND ASSEMBLY ON SITE Available space Height: Width: Length: Technical area Clean Room Area Dimensions of gates and doors Height: Width: Length: Maximum room height at the place of installation: 5. REQUIREMENTS FOR COMPONENTS Material Parts in Contact with product: Stainless Steel AISI 316L Others (Delta ferrite Requirements, etc.). Technical Surfaces Roughness Ra < 0,8 μm polished Roughness Ra < 0,8 μm electro polished. Gaskets Materials EPDM PTFE. For other applications within clean rooms : stainless steel (AISI 304) Carbon Steel galvanised for pipe fixing. 3/7
4 Vessel Vessel 1 Vessel 2 Vessel 3 Characteristics Type of Use Min. stirring volume [l] Net volume [l] N2 overlay yes / no / / / Performance Fixed / Mobil Tank / / / Material Product-related surfaces μm μm μm Electro Polished Pressure [bar (g)] Temperature Double shell Half-pipe coil Insulation Ventilation filter Type of filter Heating yes / no / / / Instrumentation Level measurement Weighing system Overflow protection Dry-run protection Temperature Pressure Gage Transmitter / / / Sample Valve Double shell and cooling procedure instead of heat exchanger 4/7
![Electro Polished Pressure [bar (g)] Temperature Double shell Half-pipe coil Insulation Ventilation filter Type of filter Heating yes / no /](/docs-images/47/20793365/images/page_4.jpg "/ / Instrumentation Level measurement Weighing system Overflow protection Dry-run protection Temperature Pressure Gage Transmitter / / /")
5 Insulation - Vessel Hermetically welded Stainless steel sheeting, screwed Aluminium sheeting, screwed Insulation Heat Exchanger Type Double Tube Sheet (DTS), according to pharmaceutical standard Insulation Heat Exchanger Stainless steel sheeting, screwed Aluminium sheeting, screwed Insulation Pumps Double pump station Stand-by pump Single floating mechanical seal Variable speed control / frequency converter Valves Diaphragm Valve EPDM-Membrane PTFE-Membrane for all valves Position control for a single position for GMP-relevant valves both positions (open / closed) for all valves used for pure medias Piping Pipe standards DIN line A (11850 R2) recoended DIN line B (ISO 1127) DIN line C (ASME BPE). Surfaces Ra </=0,8μm, in a longitudinal seam Ra</=1,6μm; mechanically polished Ra </=0,8μm, mechanically polished Ra </=0,8μm, electro polished 5/7
6 Pipe Fittings Clamp Flange according to ISO 2852 or DIN Sterile Connection according to DIN CONTROL SYSTEM Please take note of further questionnaire for Automation and Control System 7. MEDIA LIST WFI Purified water (PW) Town Water (Drinking Water) Black Steam Pure Steam Cooling Water Supply Compressed Air sterile Yes / Nitrogen sterile Yes / Flow Rate Flow Rate Waste Water. 6/7
7 8. DOCUMENTATION GMP-documentation according to Pharmatec standard Surface roughness protocols Vessel documentation according to: EC pressure equipment directive PED 97/23 EG ASME Code Material Certificates according DIN EN FDA - Declaration of Conformity 9. SERVICE ON SITE Insertion and Installation Calibration (GMP-relevant measurement chains) Coissioning IQ / OQ (assistance) Training Cover of accoodation and local transfer costs by customer (airport, hotel and construction site) 10. AVAILABLE DOCUMENTS Building floor plan including position of the cleaning object and the prospective installation site P+ID flow sheet / process schemata Further specifications Compliance to factory specifications 11. DELIVERY Delivery according to INCOTERMS 2010: 7/7
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