The Question posed on LinkedIn:
“What should be the temperature for Purified water used for Equipment washing and Manufacturing of Oral solids? Should it be 60-80C or it can be used at 22C with circulation of water? Need references“
My reply was this:
The point of use water can be any temperature as long as you have successfully validated cleaning processes. The water in the pipes needs to stay at the regulated temperature(s). ICH, WHO, PIC/S and the FDA all have relevant documentation you can find using a keyword search. For example, CFR – Code of Federal Regulations Title 21, WHO good manufacturing practices: water for pharmaceutical use. For manufacturing, again this comes down to how you have validated the process. If your API is temperature sensitive, then you would need to reduce the temperature of the purified water used. Filling your mixing vessel and validating your hold time comes into play here. “
An ex EU GMP inspector stated he agreed with me. Knowing what I say is approved by inspectors is very nice to hear.