| The following procedures are applicable
for determining whether a Pharmacopeial article purporting to be sterile
complies with the requirements set forth in the individual monograph with
respect to the test for Sterility. In view of the possibility that positive
results may be due to faulty aseptic techniques or environmental contamination
in testing, provisions are included under Interpretation of Sterility Test
Results for two stages of testing.
Alternative procedures may be employed
to demonstrate that an article is sterile, provided the results obtained
are at least of equivalent reliability. (See Procedures under Tests and
Assays in the General Notices and Requirements.) Where a difference appears,
or in the event of a dispute, when evidence of microbial contamination
is obtained by the procedure given in this Pharmacopeia, the result so
obtained is conclusive of failure of the article to meet the
Media Media for the tests may be prepared as described below, or dehydrated mixtures yielding similar formulations may be used provided that, when reconstituted as directed by the manufacturer or distributor, they have growth-promoting properties equal or superior to those obtained from the formulas given herein. 1. Fluid Thioglycollate Medium.
Use Fluid Thioglycollate Medium by incubating under aerobic conditions. 2. Alternative Thioglycollate Medium
for Devices Having Tubes with Small Lumina.
Heat the ingredients in a suitable container until solution is effected. Mix, and, if necessary, adjust the solution with 1N sodium hydroxide so that, after sterilization, it will have a 7.1 ± 0.2. Filter, if necessary, place in suitable vessels and sterilize by steam. The medium is freshly prepared or heated in a steam bath and allowed to cool just prior to use. Do not reheat Use Alternative Thioglycollate Medium in a manner that will assure anaerobic conditions for the duration of the incubation period. 3. Soybean-Casein Digest Medium.
Dissolve the solids in the water,
warming slightly to effect solution. Cool the solution to room temperature,
and adjust 1 N sodium hydroxide, if necessary, to obtain a pH of 7.3 ±
0.2
Use Soybean-Casein Digest Medium by incubating it under aerobic conditions. Diluting and Rinsing Fluids FLUID A- Dissolve 1 g of peptic digest of animal tissue (see Reagent Specifications in the section Reagents, Indicators, Solutions) in water to make 1 liter, filter or centrifuge to clarify, adjust to a pH of 7.1 ± 0.2, dispense into containers in 100 mL quantities, and sterilize by steam. FLUID D- For device sterile pathway tests using membrane filtration, use fluid A to each liter of which has been added 1 mL of ploysorbate 80, adjust to a pH of 7.1 ± 0.2, dispense into flasks and sterilize by steam. FLUID K-
Growth Promotion Test Confirm the sterility of each lot of medium by incubation of representatíve containers, at the temperature and for the length of time specified in the test. Test each autoclaved load of each lot of medium for its growth promoting qualities by separately inoculating duplicate test containers of each medium with 10 to 100 viable microorganisms of strains listed in the accompanying table, and incubating according to the conditions specified. The test media are satisfactory if clear evidence of growth appears in all inoculated media containers within 7 days. The tests may be conducted simultaneously with the use of the test media for sterility test purposes. The sterility test is considered invalid if the test medium shows inadequate growth response. If freshly prepared media are not used within 2 days, store them in the dark, preferably at 2º to 25º C. Finished media, if stored in unsealed
containers, may be used for not more than one month, provided that they
are tested within one week of the time of use and if the color indicator
requirements are met. If stored in suitable sealed containers, the media
may be used for not more than one year, provided they are tested for growth
promotion every three months and if the color indicator requirements are
met.
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