Requirements for packaging bags of medical devices
Used for packaging medical device products, can be sterilized, provide acceptable microbial barrier properties, can protect the product before and after sterilization, and can maintain the sterile environment inside the system for a certain period of time after sterilization. Guangxi Medical Devices
Structure composition: bag or blister shell, paper plastic bag and paper bag. The blister box is made of PET, or PP, or PETG blister box heat-sealed medical adhesive paper. At present, it is mainly DuPont Tyvek blister cover material Tyvek adhesive paper. Mainly medical device manufacturers and hospitals, double-sided adhesive self-reverse buckle adhesive. Packaging principle: instrument loading, sealing, sterilization, the bag through the principle of sterilization factor can be stored for a certain period of time, to achieve the barrier effect of medical sterilization packaging bags. Applicable sterilization methods: EO ethylene oxide, high temperature hot steam, Gamma drill 60 ray irradiation, plasma, etc.
Put the sterilized instruments into the packaging bag, and after sealing, kill the microorganisms on the instruments in the bag by physical or chemical methods, so as to keep the instruments in the sterile state within the specified validity period. Specifically, it can include the following functions: it can adapt the corresponding sterilization process; it can protect the equipment and keep the equipment under acceptable conditions of use; it has bacterial barrier properties and can maintain the sterility and integrity of the equipment before use; it can be used for sterile opening of the instrument; and it can correctly identify and use the product. Guangxi Medical Equipment Company
The materials contained must be microbial-barrier, compatible with the promised sterilization method. Keep the product sterile, the packaging should not have the opportunity to be damaged by air pollution, fiber, dust and other foreign matter and microorganisms. Therefore, the packaging needs to ensure no damage to the material; full sealing and shell strength. The included material or packaging shall be suitable for subsequent processing. Materials shall be manufactured to minimize the shedding of particles such as fibers, flakes, ink spills, and dust. After opening the package, there should be signs that it has been opened. After the package is opened, it shall not be sealed again to avoid re-sealing after the package is contaminated.
The opening position and direction must be determined. It should be easy to open, and the opening position should be easy for users to open. The product must be identifiable, and the printed mark must meet the requirements of the medical device, including transparent side materials that can see the internal product.
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