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Development of a non-viable particulate monitoring system for drugs manufactured in an aseptic environment.

Automated non-viable particulate monitoring systems can significantly reduce sampling costs while providing increased assurance that pharmaceutical products are free of microbial contamination. The need for consistently reliable data in the batch release process requires incorporating adequate fail-safes to detect operator error and hardware malfunction. Use of the "Life Cycle Approach" in system design and validation is also needed to provide assurance that the system will continue to meet its specifications. The author has collaborated with an instrument vendor to design, install and validate a data gathering and reporting system. Test function design is also discussed.