Sanitation monitoring procedures

Other manufacturing procedures requiring validation include cleaning, decontamination and sanitation (CDS) procedures developed for specific items of equipment/processing areas. Of particular importance is the ability of such procedures to remove bioburden. This may be assessed by monitoring levels of microbial contamination before and after application of CDS protocols to the equipment item in question. 

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. 

If sterility test contaminant is same as routine environmental contaminant the sterility test is voided. Investigate sterility test procedures and room sanitation/sterilization methods to eliminate cause. If media-fill environmental contaminant is same as routine environmental contaminant increase the number of media-fill vials in media hll to determine the product risk potential. Review monitoring technique for possible problem. Review personnel practices, gowning, sanitation, and sterilization. 

Deionization equipment should have proper size to allow frequent regeneration. A recirculation system should also be installed in the unit that approaches the rated flow of the deionization unit. Procedures should be written to ensure that all water treatment equipment is properly operated, monitored, maintained, and sanitized on a regular basis. 

The environment of an aseptic filling operation must be monitored and controlled. Environmental control begins with valid cleaning and sanitization procedures, then proceeds with adequacy of certified HEPA filtration and clean room procedures by personnel within the clean room, and is verified by environmental monitoring techniques. Such techniques include nonviable particulate... 

A comprehensive Facility Cleaning and Sanitization Program with an initial schedule for each room will be developed, with procedures based on the initial sanitization validation results, the criticality of operation performed in each area, and the frequency of use. The initial schedule will be modified as necessary based on routine environmental monitoring. The environmental monitoring results will be compared against alert and action levels. 

The chemical and microbiological quality of water used in production should be specified and monitored. Care should be taken in the maintenance of water systems in order to avoid the risk of microbial proliferation. After any chemical sanitization of the water systems, a validated flushing procedure should be followed to ensure that the sanitizing agent has been effectively removed. 

Quality control must monitor that sanitation programs and procedures are adhered to in the sterile area. 

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