COMMERCIAL ITEM DESCRIPTION A-A-51636A
test bottle. Insert the piercing device of each prepared spike into the bottle in the normal manner. When the vacuum in the liter test bottle has been displaced, disconnect the testing apparatus from the filter and shake the bottle thoroughly to mix the aerosol content and to wet all surfaces. Retain the spike assembly in the bottle for venting and incubate at 31° ± 1° C for seven days. As a control to assure that aerosol is challenging the filter correctly, remove the air filter from the spike assembly of two additional bottles and connect the nebulizer. When the vacuum has been displaced, disconnect the nebulizer and replace the filter. After mixing the bottle contents, determine the bacterial count of the bottle. Once the seven day incubation is over, mix the bottle contents and determine the bacterial count of the bottle. The filter shall be such that the rate of contamination of the test samples shall be not greater than 0.1%.
Contractor certification. The contractor shall certify that the product offered meets the salient characteristics of this description and conforms to the producers’ own drawings, specifications, standards, and quality assurance practices. The Government reserves the right to require proof of such conformance prior to first delivery and thereafter as may be otherwise provided for under the provisions of the contract.
Regulatory requirements.
Federal Food, Drug and Cosmetic Act. If the product covered by this document has been determined by the U.S. Food and Drug Administration to be under its jurisdiction, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of Federal Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder. In addition, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of all other applicable Federal, State, and local statutes, ordinances, and regulations.
Recovered materials. The offeror/contractor is encouraged to use recovered materials in accordance with Public Law 94-580 to the maximum extent practical.
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