IMS For Cleaning Verification

By: Kent Payne, Wayne Fawber, Jose Faria, Joey Buaron, Reno DeBono, and Azhar Mahmood

Cleaning verification is one of the critical processes in pharmaceutical manufacturing. Equipment contamination can come from any of the materials that have been in contact with the equipment surfaces, including active pharmaceutical ingredients (APIs) from previous runs and cleaning agents. It is critical to avoid carryover of trace amounts of either active or other materials from one batch to another to avoid adulteration of the product.

For that reason, equipment used in pharmaceutical manufacturing must be cleaned before each use, and the cleaning procedure used must be in accordance with good manufacturing practices (GMPs). Before cleaning validation, cleaning verification procedures describing specific sampling and associated analytical methods are used to demonstrate the efficacy of the cleaning procedure.

Volumes of information have been written on cleaning verification in print and online, and many universities offer courses dedicated to this topic. FDA has standards (for example, 21 CFR Part 211.67) and associated guidances detailing requirements and offering interpretations for cleaning verification. Companies spend significant resources developing and validating the analytical methods required for cleaning verification. The analytical method must be specific, sensitive, accurate, and precise, and, to be cost-effective, it must be fast. Along with these requirements, the analytical method should be easy-to-use and it must be compliant with 21 CFR Part 11, FDA's regulation for electronic data collection.

SOURCE: Smiths Detection