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BIOLOGIC PRODUCT STERILITY TESTING: VALIDATION

Executive Summary

BIOLOGIC PRODUCT STERILITY TESTING: VALIDATION can replace need for liquid culture medium testing on a lot-by-lot basis, according to a revision in FDA regulations covering biological sterility testing announced in the December 15 Federal Register. The revised reg clarifies that "when using a single batch of dehydrated culture medium, a manufacturer need not perform growth-promoting tests on each lot of prepared liquid medium, provided that a validation program exists for autoclaves used to sterilize the culture medium, and the manufacturer has received approval for this practice" from FDA. In addition to receiving approval from FDA for the validation program, FDA noted that "the manufacturer must specify in its standard operating procedures the exact formulation of each culture medium to assure reproducibility." The formulation, FDA stated, "would include such items as the weight of the culture medium used, the volume of distilled water used, the length of boling time used to dissolve the agar, and the proper cleaning of the glassware used for sterilization of the culture medium." FDA noted that it was updating certain requirements concerning the growth-promoting qualities of the sterility test culture media and the microorganisms used in quality testing of the media to eliminate confusion among biological manufacturers about agency requirements and to bring the regulations into line with the "more stringent" United States Pharmacopeia (USP) compendial standards. The revised reg provides a chart listing the mircroorganisms acceptable for use in testing the culture medium. The reg clarifies that at least two organisms must be used to test each lot. When using Fluid Thiogycollate medium, the reg states, "both an aerobic and an anaerobic test microorganism shall be chosen." When using Soybean Casein Digest Medium, "the yeast, Candida albicans, shall be one of the two test microorganisms chosen." The updated regulation also clarifies that manufacturers can use different sized vessel containers in a single autoclave run when preparing culture medium, provided that "the growth-promoting quality test shall be performed on the smallest sized vessel used."
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