A-A-53441B
The paper and plastic surfaces shall be sufficiently permeable to permit contents to be sterilized using steam and ethylene oxide, and sufficiently permeable after sterilization so that contamination from the atmosphere shall not enter the closed envelope. The plastic surface shall permit easy product identification and shall be no less than 2 mils thick. Envelopes shall be specifically designed for containment of items during sterilization and aseptic handling and presentation after sterilization. Size of envelopes are approximate (± 1/2 inch (1.27 cm) and overall measurement is listed.
Size 1 – 3-1/2 inches wide X 5-1/4 inches long
Size 2 – 7-1/2 inches wide X 13 or 13-1/2 inches long
Size 3 – 12 inches wide X 15-16 inches long
Each sterilization envelope shall have steam and ethylene oxide chemical indicators which shall provide visual indication that exposure to the sterilization process has occurred. The steam indicator shall not fully change color when exposed to ethylene oxide. The ethylene oxide indicator shall not fully change color when exposed to steam.
The envelope shall be free of tears, cuts, holes, perforations, grease, dirt or foreign matter.
Packaging and labeling shall meet the requirements of the Federal Food, Drug, and Cosmetic Act and shall be that usually furnished by the supplier as commercial practice. Minimum marking shall include the company name and part number. Instructions for opening and sealing the envelope shall be provided on each envelope, or shall be supplied with each intermediate of shipping container. Instructions and any other marking on the envelope shall be legible before, during and after sterilization.
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