Validation for cleanrooms serves many purposes for many industries. For the medical device and pharmaceutical industries it helps ensure regulatory compliance with ISO, FDA, and EU standards. The primary purpose of validation is to identify, assess, and resolve contamination issues. Items like viable and non-viable sampling and gowning and cleaning validation are part of the many audits performed for regulatory compliance.
Since contamination can come from anywhere, PMSI is able to provide comprehensive testing for all cleanroom needs. Validation applies to the process, equipment, and facility. In-depth validation will also apply to items like computers, documentation, and cleanroom procedures. PMSI can help set up and write validation plans specific to the client and process. Part of this process is also writing and executing qualification protocols inside the cleanroom and assisting in internal and FDA audits.
Contamination Control Audits.
With the ever changing regulations, guidelines and practices for manufacturing in all industries, many companies have found themselves in need of a cleanroom. PMSI can visit current facilties to audit the conditions of the existing facilities in order to make recommendations to reach ISO Standards, or other necessary regulations. We can provide a comprehensive report on how to use and change the current facility, gowning, cleaning, and production practices in order to accommodate the client.