E10-0100 Critical Utilities - Design
Critical Utilities in a GMP facility includes Purified Water System, WFI, Pure Steam & others.
The documents will cover the processes in an equipment cGMP Life-Cycle from URS, design, construction, qualification to Maintenance eg:
- Design Specification, User Requirement Specifications, Functional Specification
- Design guidelines and calculation – eg
- E10-0101 Design & construction guidelines for a Purified Water System
- Design Calculation
- E10-0103 Our MS Excel Spreadsheet is a “MUST HAVE” for all facilities having a Purified Water System. It is a simple and inexpensive tool to help you understand your water usage and how to estimate the size of the purified water generator, storage tank and piping.
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