Transcription of 61 MICROB IOLOG ICAL E X AMIN AT ION OF N ON ST E RILE …
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61 MICROB IOLOG ICAL E X AMIN AT ION OF N ON ST E RILE …
11/21/201634(6) Sixth Interim Revision Announcement: 61<61> MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: MICROBIAL MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: MICROBIALENUMERATION TESTSINTRODUCTIONThe tests described hereafter will allow quantitative enumeration of mesophilic bacteria and fungi thatmay grow under aerobic tests are designed primarily to determine whether a substance or preparation complies with anestablished specification for microbiological quality. When used for such purposes, follow theinstructions given below, including the number of samples to be taken, and interpret the results asstated methods are not applicable to products containing viable microorganisms as active microbiological procedures, including automated methods, may be used, provided thattheir equivalence to the Pharmacopeial method has been PROCEDURESC arry out the determination under conditions designed to avoid extrinsic microbial contamination ofthe product to be examined.
Agar/MPNSoybean– Casein Digest Broth 100 cfu30 –35 3 days Ca ndi da a l bi c a ns such as ATCC 10231, NCPF 3179, IP 48.72, or NBRC 1594 Sabouraud Dextrose Agar or Sabouraud Dextrose Broth 20 –25 2–3 days Soybean– Casein Digest Agar 100 cfu 30 –35 5 days Sabouraud Dextrose Agar 100 cfu Soybean–Casein Digest Agar 100
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