Similar to what the FDA has mandated in the pharmaceutical, bio-pharmaceutical, and medical device industries, the food manufacturing industries are being required to validate the manufacturing processes of high risk foods to ensure that all of the systems have a consistent high level of assurance to produce a product that consistently meets its pre-designed specifications. This gives a company a control system that is consistent and reproducible. Further, a validated process is credible and stable, because the acceptance criteria have already been specified in the qualification stages of validation.

If the specifications of the system, how it is designed, and how it is to operate are known, then it becomes possible to maximize the performance of that system. If validation is performed properly and with the right objectives, it can be a value-added process for the company.

This cleanroom tip was taken from “Ask Jan: Validation of Aseptic Cleanrooms for Co-Packing Food Items,” which appeared in the May 2013 issue of Controlled Environments.