By Bob Latimer
Aseptically produced, parenterally administered biopharmaceutical products must be free of unwanted bacterial or viral contaminants. Product quality must be built into the manufacturing and filling processes and assured via a carefully designed and executed environmental monitoring (EM) program. An effective EM program provides the primary means by which a contamination control strategy can be assessed, with EM results forming a fundamental component of the batch release process.
Generally, the air surrounding aseptic filling lines found in GMP compliant biopharmaceutical production facilities is controlled by the use of cleanroom suites, mini-environments, RABs and isolators. To assure quality and sterility, these environments are maintained and controlled to adhere to stringent conditions laid out in one or more Good Manufacturing Practices such as cGMP1, EU-GMP2, and PIC/s3. These directives require continuous air particle monitoring during filling operations in addition to routine monitoring of supporting clean zones, conducted to a controlled SOP driven schedule. In addition, GMP requires that such controlled environments are periodically reclassified according to ISO-14644-14.