USP无菌检测法.doc

MEDIA Prepare media for the tests as described below, or dehydrated formulations may be used provided that, when reconstituted as directed by the manufacturer or distributor, they meet the requirements of the Growth Promotion Test of Aerobes, Anaerobes, and Fungi. Media are sterilized using a validated process. The following culture media have been found to be suitable for the test for sterility. Fluid Thioglycollate Medium is primarily intended for the culture of anaerobic bacteria. However, it will also detect aerobic bacteria. Soybean– Casein Digest Medium is suitable for the culture of both fungi and aerobic bacteria. Fluid Thioglycollate Medium L-Cystine 0.5 g Sodium Chloride 2.5 g Dextrose (C6H12O6·H2O) 5.5/5.0 g Agar, granulated (moisture content not exceeding 15%) 0.75 g Yeast Extract (water-soluble) 5.0 g Pancreatic Digest of Casein 15.0 g Sodium Thioglycollate 0.5 g or Thioglycolic Acid 0.3 mL Resazurin Sodium Solution (1 in 1000), freshly prepared 1.0 mL Purified Water 1000 mL Mix the L-cystine, sodium chloride, dextrose, yeast extract, and pancreatic digest of casein with the purified water, and heat until solution is effected. Dissolve the sodium thioglycollate or thioglycolic acid in the solution and, if necessary, add 1 N sodium hydroxide so that, after sterilization, the solution will have a pH of 7.1 ± 0.2. If filtration is necessary, heat the solution again without boiling, and filter while hot through moistened filter paper. Add the resazurin sodium solution, mix, and place the medium in suitable vessels that provide a ratio of surface to depth of medium such that not more than the upper half of the medium has undergone a color change indicative of oxygen uptake at the end of the incubation period. Sterilize using a validated proce