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 Sub-Category:

  • 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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