Victoria,
Your dept should have procedures to address compromise to the WFI System.
The WFI System becomes compromised as soon as the leak occurs, and not when
you attempt to rectify the problem. Steam sterilisation is a must.
You may also wish to identify all manufacturing batches that are implicated
and perform a risk assessment. Reliance on test results only will provide a
false sense of security, is contrary to cGMP principles and is also a
citable offence.
Hope this helps,
Precious Emovon
SmithKline Beecham Pharm.
Parenterals Manufacture
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