What Are The Sterilization Requirements For Medical Pouches?
Medical pouches are composed of paper + plastic composite film, used for the packaging of medical devices to be sterilized, belonging to the initial inner packaging of the product, the paper side of the pouch generally needs to be printed with information about the manufacturer or product of the medical device.
According to EN868-5, the printing area should not be greater than 50%. Alias sterilization packaging bags, sterilization packaging bags, medical reagent packaging bags, medical paper-plastic bags.
Medical composite film medical packaging bags can be suitable for: EO ethylene oxide, high-temperature steam STEAM, such as hospitals to sterilize or sterilize medical equipment high-temperature steam used to contain the items to be sterilized.
High temperature sterilization is not suitable for PET (polyester) / PE (polyethylene) colorless transparent medical composite film, because PE itself is not resistant to high temperature, glue is not high temperature, irradiation sterilization is not recommended to use PET (polyester) / CPP (polypropylene). Because irradiation rays have aging and embrittlement effect on CPP, and may precipitate harmful halides.
Generally, the product is put into the bag in a clean workshop, such as a 100,000 class cleanroom, and then the bag is sealed with a heat sealing machine and put into a carton and sterilized in a sterilization cabinet, and then the shelf life is generally divided into 1 year, 3 years, and 5 years depending on the material, and aging verification is done to ensure that the medical products in the bag are sterile in transportation and storage until the final hospital nurse opens them. The medical products inside the bag are sterile products, no need to sterilize again, can be used directly.
Principle of action.
Using the semi-permeability of the packaging material and bacterial resistance, so that EO ethylene oxide or steam and other sterilization gas through to achieve sterilization effect, to prevent bacteria re-enter the bag. Ensure that the bag remains sterile until it is opened within the required storage, transportation and expiration dates.
Maintain the aseptic state of the product. The packaging should not have the opportunity to be contaminated by air, broken fibers, dust and other foreign matter, microbial invasion.
Therefore, the packaging needs to ensure that: the packaging material is not damaged; the seal is intact, the peel strength is appropriate, no penetration, no burst, peel clean. Must adapt to the committed sterilization method ISO11134/ISO11135/ISO11137.