A-A-51373A
Sterility test. The surgical gowns shall be treated for sterility in accordance with the method specified in the U.S. Pharmacopeia of Convention Publication: Pharmacopoeia of the United States, Mack
Publishing Co., Easton, PA 18042 (USP), for purified cotton, gauze, surgical dressings and related material using inoculated product, inoculated simulated product, or paper spore strip (carrier). The incubation temperature shall be as listed below. Product containing a biological indicator shall be marked or labeled, so that it clearly differentiates from product intended for product intended for distribution. The incubation medium and minimum time in each case shall be soybean casein digest for 7 days for inoculated product. The minimum number of test units, regardless of lot size, shall be 10, except for inoculated carrier which shall be 20. For sterilization, the organism used shall be as listed below:
|
Type of Sterilization |
Organism |
Incubation Temperature Degrees C |
|
Steam |
B.stearothermophilus |
55 – 65 |
|
Dry Heat |
B.stearothermophilus |
55 – 65 |
|
|
B.subtilis var. niger (or globigii) |
30 – 35 |
|
Gas |
B.subtilis var. niger (or globigii) |
30 – 35 |
|
Radiation |
B. pumilus |
30 – 35 |
The number of viable cells shall be sufficient to provide assurance that the product has been sterilized.
Inoculated carriers (paper spore strips) if used shall be in accordance with MIL-s-36586. Other paper carriers shall be inoculated to be of equivalent resistance. The method, incubation and number of test units shall be as indicated herein for inoculated product or simulated product. The method of sterilization will control organism in the spore strip to be tested for as shown above.
NOTE: When an inoculated carrier is chosen product samples must also be tested as required by the USP.
Alternate method. Suppliers conducting sterility tests in a manner other than that indicated herein shall submit proof that the alternate method provides equal assurance concerning the sterility of the product. Requests for approval of any alternate method of testing for sterility shall be made to the Contracting Officer, and approval obtained before employment of the alternate method on a Government contract. Dosimetry release as approved by FDA is acceptable.
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