Microbiologic monitoring personnel

ABC Pharmaceutical Industries routinely monitors the microbial content of the air, inanimate surfaces, personnel, water systems, and product component bioburden. Microbiological monitoring of these areas generally reflects on the efficiency of cleaning and sanitization procedures and employee practices. Continuous environmental monitoring provides the assurance that product is produced by a controlled process that will maximize the sterility and quality of the manufactured sterile product. 

It is easily understood that if the aseptic operation is performed in a separated small space from which personnel have been completely excluded, the necessity for room classification based on particulate and environmental microbiological monitoring requirements may be significantly reduced. In other words, critical operations in an aseptic area should be performed in the smallest space, and intervention by personnel should be minimized by indirect means through the use of protective glove ports and/or half suits. Application of these methods can minimize the chance of contamination. Following are such systems currently in place to reduce the contamination rate in aseptic processing. 

Personnel bioburden will be analyzed per SOP (provide number). In addition, QC/microbiology will perform audit monitoring of all media hll participants, including themselves. 

Installation and certification of laminar air flow areas where sterile air is provide via high-efficiency particulate air (HEPA) filters Environmental monitoring of the facility, equipment, water, and personnel for strict microbiological and particulate control... 

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