Devices and instruments are sterilized in their packaging. Appropriate packaging allows effective sterilization and maintains sterility to the point of use of the packed product. Compatibility of the packaging system with the product to be packed and with its sterilization method, handling procedures, marking, and labeling has to be verified. Transportation, warehousing, and stackability needs cause added strains to materials. A well-designed medical packaging solution facilitates aseptic entry of the packed sterile item into use.
Porous packaging materials, such as medical-grade paper are used often by the medical device industry for packaging sterile devices when the products are sterilized post packaging. Their use can be attributed to the fact that multiple sterilization methods require the ability for vapors to enter and/or exit the package efficiently, while simultaneously reducing the amount of microbes entering the package. Much research as been done to study the effects of multiple material and environmental factors, such as material structure and dispersion concentration, on the microbial barrier properties of these materials.
Several techniques can be used to sterilize medical products. Each sterilization method adds different constraints, requirements, and stresses to the packaging system. Because some sterilization methods such as Ethylene Oxide (EtO), Vaporized Hydrogen Peroxide (VHP), and steam autoclave use gases or vapors to achieve sterility, porous materials, such as medical-grade papers, have become the prominent packaging materials in the medical device industry. Porous materials allow gases and vapors to enter and exit the package while simultaneously inhibiting microbes from entering the package.
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Ink Sealer Device Test (RRS 14-81210)
