A-A-51219A
Pressing the cap down shall cause the ampule to be sealed from its surroundings and crush the medium vial, allowing the medium and spores to mix. The vial shall be clear and colorless. The indicators shall be capable of showing bacterial growth by changing the ampule’s content color from red to bright yellow within a 48 hour time frame. The growth medium shall sustain a 7 day incubation period without a color reversal when properly sealed.
When teamed with the aforesaid incubator, the system shall meet the U.S.P. XIX and U.S.P XX Standards. The overall height of the indicator, with the cap not pressed, shall be approximately 6.0 centimeters. The labeling of the indicator shall meet the requirements of the Food, and Drug Administration and the Federal Food, Drug and Cosmetic Act. The overall height of the indicator with the cap pressed shall be approximately 5.4 centimeters. The outside diameter of the ampule, below the cap, shall be approximately 1.3 centimeters. The labels of the immediate container and the unit package of supply shall be those usually furnished by the supplier as commercial practice. Additions to these labels shall be limited to the application of the NSN to the unit package, and the expiration date to the immediate container (strip labeling is acceptable). When the unit package is the shipping container, additional labeling may be applied.
Workmanship. Workmanship shall be first class throughout. The sterilization ampules shall be free from defects which detract from their appearance or impair their serviceability.
Unit. Package (PG). One package containing one hundred indicators along with directions for use, as specified, constitutes one unit.
Quality Assurance Provisions.
Responsibility for inspection. Unless otherwise specified in the contract or purchase order, the contractor is responsible for the performance of all inspection requirements as specified herein. Except as otherwise specified in the contract or purchase order, the contractor may use his own or any facilities suitable for the performance of the inspection requirements specified herein, unless disapproved by the Government. The Government reserves the right to perform any of the inspections set forth in the specification where such inspections are deemed necessary to assure supplies and services conform to prescribed requirements.
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