Particulate Monitoring Nonviable of Injectable Area

SUBJECT Particulate Monitoring (Nonviable) of Injectable Area 

This procedure defines requirements for monitoring of air quality relative to airborne particulates of injection manufacturing and packing area and delineates the responsibilities for assurance of compliance with this procedure. The room number, activity, and location number defined are hypothetical. Individual companies can apply the SOP as a model to develop their own SOPs. 

Area QAl (quality assurance inspector) is responsible for following the procedure. Production manager and quality assurance manager are responsible for SOP compliance. 

In the pharmaceutical industry, reduction and/or elimination of microbially nonviable particulates in the environmental air reduces the possibility of product contamination during processing. Particulate matter and microbial monitoring programs are necessary for areas where product quality can be affected by environmental conditions. 

Following are the airborne particulate cleanliness classes. Each class is defined by the maximum allowable number of particles equal to or greater than 0.5 and 5.0 pm in size per cubic foot of air. The class is considered met if the measured particle concentration per cubic foot is within the limits specified. 

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Particulate monitoring (nonviable) of injectable area Fill volume/weights and other checks for parenteral products during filling... 

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