Packaging systems used for medical device products, which can be sterilized, can be aseptically operated (e.g., clean open), can provide acceptable microbial barrier properties, before and after the sterilization of the product can be protected and can be used to maintain a sterile environment inside the system within a certain period of time after sterilization (marked expiration date).
Medical device pouches can be suitable for sterilization:
ETO ethylene oxide, high-temperature moist steam, gamma cobalt 60 irradiation, plasma, formaldehyde and so on.
Structural components: bags or blister boxes
Bags: paper-plastic bags and paper-paper bags are mainly (paper-plastic bags are mostly U.S. paper, French paper, British paper; paper-paper bags for domestic paper)
Blister boxes: blister material PET, or PP, or PETG and other blister boxes outside the heat sealing medical adhesive coated paper, the current most for the Dupont Tyvek blister cover Tyvek coated paper)
Blister boxes: blister materials PET, or PP, or PETG, and so on. (
Object: medical device manufacturers and hospitals are mainly.
Sealing form: hot pressure sealing machine sealing and double-sided adhesive self-buckling adhesive sealing
Quality standards: international ISO11607; the European Union for the EN868; China's GB/T19633
Packaging principle: loaded into the device, sealing, sterilizing, bag sterilization through the principle of bacterial barrier factor can be preserved for 1-5 years to achieve the barrier of the sterilized medical packaging bags. Role
Functional role: the instruments to be ultimately sterilized into the bag, after sealing, can be physically or chemically, the bag of microorganisms on the instruments killed, and can be in the stipulated period of validity, to maintain the instruments in the bag in a sterile state. Specifically, the following utilities may be included
adaptable to the appropriate sterilization process;
protecting the instrument to maintain the instrument in an acceptable condition for use;
having bacterial barrier properties that maintain the sterility and integrity of the instrument prior to use;
being able to be opened aseptically for use of the instrument;
correctly identifying and using the product.