ABSTRACT
The pharmaceutical industry has historically employed various means to provide a controlled local environment at critical points in the manufacturing and testing of pharmaceutical products. The design of manufacturing facilities must ensure personnel are protected from potent and/or potentially hazardous active pharmaceutical ingredients and excipients. Equally important is the need to protect pharmaceutical products, especially aseptically produced sterile products, from particulate and microbiological contamination from people and the surrounding environment. Drug manufacturing facilities are typically designed to have the highest environmental quality in the areas where the product is directly exposed to the environment. In this context, high quality means the air and product contact surfaces have low levels of nonviable particulate and microbiological contamination. In the case of sterile products produced by aseptic processing, the expectation is the air contacting the sterilized product and sterile product contact surfaces should be also be sterile. Air quality is achieved using terminal highefficiency particulate air (HEPA) filtration and monitored through integrity testing of the filter media prior to initial use and periodically thereafter. Similarly, the solutions used to cleanse surfaces are filtered through microbial retentive filters to minimize particulate contamination (1).
