Microbiologic monitoring of controlled process

Microbiologic Monitoring of Controlled Processes Table 2A Relative cost/difficulty comparisons... 

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. 

The United States Pharmacopeia USP 35 (2012) The United States Pharmacopeial Convention. Rockville. <1116> Microbiological control and monitoring of aseptic processing environments... 

The rationale of the classifications may best be seen by reference to products and processes with different levels of control. As a first example, the classification of holding times for bulk solutions and for microbiological monitoring shown in Fig. 1 as major apply to a product that is capable of supporting microbial growth these could be relaxed to minor for inimical products. 

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