0065非无菌产品检验特定微生物测试.pdfVIP

60 61 Microbiological Examination / Microbiological Tests USP 35 TESTING OF PRODUCTS dium of the counts, and calculate the number of cfu per g or per mL of product. Surface-Spread Method—Prepare the sample using a method that has been shown to be suitable as described in Amount Used for the Test Growth Promotion Test and Suitability of the Counting Method . Prepare at least two Petri dishes for each medium Unless otherwise directed, use 10 g or 10 mL of the prod- and each level of dilution. For incubation and calculation of uct to be examined taken with the precautions referred to the number of cfu, proceed as directed for the Pour-Plate above. For fluids or solids in aerosol form, sample 10 con- Method. tainers. For transdermal patches, sample 10 patches. The amount to be tested may be reduced for active sub- stances that will be formulated in the following conditions: MOST-PROBABLE-NUMBER METHOD the amount per dosage unit (e.g., tablet, capsule, injection) is less than or equal to 1 mg, or the amount per g or mL Prepare and dilute the sample using a method that has (for preparations not presented in dose units) is less than 1 been shown to be suitable as decribed in Growth Promotion mg. In these cases, the amount of sample to be tested is Test and Suitability of the Counting Method. Incubate all not less than the amount present in 10 dosage units or 10 g tubes for 3 to 5 days at 30 to 35. Subculture if n