Description
Having inconsistency with your Purified Water or WFI Sampling and Test Results?
Purpose
Purified water “Point-of-Use” valves may be located in various environments where the outlet side/end of the valve is exposed to the environment which may can be contaminated by both living organism and particulates.
Sometimes “Water Testing” fails – not because the water in the Distribution Loop has failed but the sample water was contaminated when it passes through the contaminated exposed surfaces of the valve.
This document explains the method to protect the internal surfaces of the exposed side/end of a zero dead-leg valve from contamination. A simple cost effective method that will save you a lot of unnecessary arguments, efforts and money.
Who will benefit from this document?
- Process/Validation Engineer
- Equipment manufacturer
- Quality Control – Water Sampling
Associated documents:
E10-0101 PWS Design Input (the design input data for your URS)
E10-01022 WFI – Design Guidelines (design, operations and maintenance of Water-for-Injection)
E10-01033 Purified Water System – Design Estimate (estimate storage tank capacity and distribution pipe size)
E10-0401 Purified Water System – Endcap Protection (this document)
