E10 Critical Utilities - Purified Water System

In most GMP environments, Critical Utilities (including Purified Water System, WFI, Pure Steam) are critical components of the manufacturing and testing processes.

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The documents will cover the processes in an equipment cGMP Life-Cycle, eg:
* Design Specification – User Requirement Specifications, Functional Specification
* Design guidelines and calculation – eg
– E10-01 Design & construction guidelines for a Purified Water System.
– E10-03 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.

* Testing, Commissioning & Equipment Qualification protocols
* Operation, Monitoring & Maintenance SOP

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