Cleaning Validation Glossary

Purified Water (PW)

Highly purified water

Purified water is a pharmaceutical grade of water used as an excipient in the prep of sterile products. According to the FDA's Guide to Inspections of High Purity Water Systems, microbial specifications have not been established but the FDA's policy states that any action limit over 100 CFU/mL is unacceptable. For larger equipment purified water is generally used for rinse sampling

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