State management status of non-woven packaging

Current management status of packaging non-woven fabrics: my country’s Food and Drug Administration stipulates that packaging non-woven fabric packaging materials are not included in the management of medical devices, and companies do not need to apply for medical device operating licenses. Therefore, there is no health department supervision for us to check, and quality depends on corporate self-discipline , Non-medical packaging non-woven products flood the market, and third-party independent inspection is lacking. When selecting CSSD, it can only be evaluated subjectively. Once the non-medical or quality packaging non-woven materials are wrongly selected, it will lead to sterility failure. There are greater security risks. To select qualified medical non-woven packaging non-woven materials, attention should be paid to the following aspects: domestic or foreign imported products must meet my country's relevant standards; in 2009, my country promulgated three industry standards for disinfection supply centers, specifying requirements Medical packaging non-woven materials should meet the requirements of 'GB/T 19633-2005 Terminally Sterilized Medical Device Packaging' [2]. When choosing a reliable brand and company, you should ask for factory quality management system certification, third-party authority inspection reports, and physical and chemical characteristics testing reports when you first purchase; when you purchase again, you should request batch inspection qualification reports. 3.2 The non-woven packaging material is made of high-temperature-resistant polypropylene through a meltblown process through multiple processes, and the microstructure is fine plastic fibers. Shrinkage after encountering high temperature is a characteristic of plastic articles. There is no real high temperature resistant plastic. High temperature resistance is also a relative concept. Therefore, packaging non-woven fabrics will also have a corresponding shrinkage reaction in the microscopic view. After high temperature sterilization, the fine plastic fibers of the non-woven fabric will shrink to a certain extent. The performance is that the non-woven fabric after sterilization is more brittle than the one before sterilization. After testing, it is found that the non-woven fabric after sterilization The longitudinal and transverse tear resistance of the cloth is significantly higher than the tear resistance before sterilization, but the flexibility is reduced. The change in the properties of non-woven packaging materials before and after is one of the reasons why packaging non-woven fabrics can only be used once. 3.3 According to research, the shelf life of sterile items is closely related to the thickness (g/m2) of the packaging cloth and the number of cloth layers [3]. After a series of sterilization and chemical washing, the second-use packaging non-woven fabric has deformed its fiber structure, has sparse holes, decreased thickness, and even has small holes that are not easily detectable by the naked eye. The bacteria resistance rate will suddenly drop or Loss of antibacterial performance. The 2002 version of the 'Technical Specification for Disinfection' requires packaging materials: during the sterilization process, sterilization agents are allowed to penetrate, provide a bacterial barrier, and ensure the sterilization state. The shelf life of sterilized items is affected by many factors such as packaging materials, sealing tightness, sterilization conditions, storage environment, etc. [4]. Use secondary packaging non-woven materials for packaging equipment, and storage after sterilization cannot reach a safe expiration date.