Pharmatec GmbH
Questionnaire
Pure Media Systems
1.
PROJECT INFORMATION:
Project Name: Client: Contact Person: Telephone / Fax N°: Email: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
Pharmatec GmbH
Questionnaire
Pure Media Systems
3.
DESIGN FEATURES
Available Technical Information
Available P+ID flow sheetYes No
Available floor plan & lay out with points of use Yes No
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 Number of POU’s: pneumatic manual Piping Segment 2 Length: m Number of POU’s:
pneumatic manual Piping Segment 3 Length: m Number of POU’s:
pneumatic manual
Piping System (Cold)
Piping Segment1 Length: m Number of POU’s: pneumatic manual Piping Segment 2 Length: m Number of POU’s:
pneumatic manual Piping Segment 3 Length: m Number of POU’s:
Number of POU’s manual
Pure Steam Pipe System
Number of POU’s Number of POU’s
Length: m Number of POU’s:
Number of POU’s manual
pneumatic
pneumatic Piping Segment 1
Pharmatec GmbH
Questionnaire
Pure Media Systems
4.
TRANSPORT AND ASSEMBLY ON SITE
Available space
Height: mm Width: mm Length: mm
Technical area Clean Room Area
Others:
Dimensions of gates and doors
Height: mm Width: mm Length: mm
Maximum room height at the place of installation: mm
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 manual polished Roughness Ra < 0,8 μm electro polished Others: .
Gaskets Materials
EPDM PTFE
Others: .
For other applications within clean rooms : stainless steel1.4301 (AISI 304) Carbon Steel galvanised for pipe fixing
Pharmatec GmbH
Questionnaire
Pure Media Systems
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
Pharmatec GmbH
Questionnaire
Pure Media Systems
Insulation - Vessel
Hermetically welded
Stainless steel sheeting, screwed Aluminium sheeting, screwed No Insulation
Heat Exchanger
Type
Double Tube Sheet (DTS), according to pharmaceutical standard Others:
Insulation Heat Exchanger
Stainless steel sheeting, screwed Aluminium sheeting, screwed No Insulation
Pumps
Double pump station Stand-by pump
Single floating mechanical seal
Variable speed control / frequency converter Others:
Valves
Diaphragm Valve EPDM-Membrane
PTFE-Membrane for all valves Others:
Position control for a single position both positions (open / closed) for GMP-relevant valves for all valves used for pure medias
Piping
Pipe standards
DIN 11866 line A (11850 R2) recommended DIN 11866 line B (ISO 1127)
DIN 11866 line C (ASME BPE) Others:
.
Surfaces
Ra </=0,8μm, in a longitudinal seam Ra</=1,6μm; mechanically polished Ra </=0,8μm, mechanically polished
Ra </=0,8μm, electro polished Others:
Pharmatec GmbH
Questionnaire
Pure Media Systems
Pipe Fittings
Clamp Flange according to ISO 2852 or DIN 32676 Sterile Connection according to DIN 11864
Others: ..
6.
CONTROL SYSTEM
Please take note of further questionnaire for Automation and Control System
7.
MEDIA LIST
WFI Temperature: Pressure: Flow Rate: ______ °C ______ barg ______ l/h Purified water (PW) Temperature:Pressure: Flow Rate: ______ °C ______ barg ______ l/h Town Water (Drinking Water) Temperature: Pressure: Flow Rate: ______ °C ______ barg ______ l/h Black Steam Temperature:
Pressure: Flow Rate:
______ °C ______ barg ______ l/h Pure Steam Temperature:
Pressure: Flow Rate:
______ °C ______ barg ______ l/h Cooling Water Supply Temperature:
Pressure: Flow Rate:
______ °C ______ barg ______ l/h Compressed Air sterile
Yes / No Temperature: Pressure: Flow Rate ______ °C ______ barg ______ l/h Nitrogen sterile Yes / No Temperature: Pressure: Flow Rate ______ °C ______ barg ______ l/h Waste Water Temperature: ______ °C Others: . Temperature: Pressure: Flow Rate: ______ °C ______ barg ______ l/h
Pharmatec GmbH
Questionnaire
Pure Media Systems
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 7
3.1 Material Certificates according DIN EN 10204 FDA - Declaration of Conformity
Others:
9.
SERVICE ON SITE
Insertion and Installation
Calibration (GMP-relevant measurement chains) Commissioning
IQ / OQ (assistance) Training
Cover of accommodation and local transfer costs by customer (airport, hotel and construction site)
Others:
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 Others:
