COMMERCIAL ITEM DESCRIPTION A-A-51273
differentiates it from product intended for distribution. The incubation medium for the paper spore strop (carrier) shall be soybean-casein digest. The incubation media for the inoculated product or inoculated simulated product shall be fluid thioglycollate or alternative thioglycollate at 30O to 35OC for one-half of the specimens and soybean-casein digest at 20O to 25OC for the remaining half of the specimens. The minimum incubation time shall be ten days. Sampling shall be as follows:
|
Medium |
Paper Spore Strip |
Inoc. Prod. Or Inoc. Simulated Prod. |
|
Soybean casein |
S-3* |
S-3* |
|
Fluid thioglycollate or Alternative thioglycollate |
|
S-3* |
* use a minimum of 20 specimens. Acceptance number is zero.
B. Inoculated product or simulated product
For each type of sterilization, the organism used shall be as listed below:
Type of sterilization
|
Steam Dry heat
Ethylene oxide Gamma radiation |
B. stearothermophilus B. stearothermophilus B. subtilis B. subtilis B. pumilus |
The number of viable spores present before sterilization shall be sufficient to provide assurance that the product has been sterilized.
C. Inoculated carrier
Inoculated carriers (paper spore strips) if used, shall be in accordance with MIL-S-36586A. Sterilization Test Strip Set, Bacteria Spore. Other paper carriers shall be inoculated to be of equivalent resistance. The method of incubation and number of test units shall be as indicated in A. Sterility test and B. Inoculate product or simulated product. The method of sterilization will control the organism in the spore strip to be tested for as shown in B. NOTE: When an inoculated carrier is chosen, product samples must also be tested as required by the USP and paragraphs A and B.
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