Medical masks Mask production standards

1. Environmental and management requirements of production enterprises In accordance with the 'Classification Catalog of Medical Devices', disposable medical masks belong to the second category of medical devices. According to the 'Regulations on the Supervision and Administration of Medical Devices', manufacturers engaged in the production of Class II medical devices need to obtain a 'Medical Device Production License' and a 'Medical Device Registration Certificate'. 1. In terms of production environment, in order to obtain the above certificates, it is necessary to have a clean production pharmaceutical cleanroom that can meet the requirements of the 'Quality Management Specification for Medical Device Production'. The cleanliness level of the production workshop is 100,000. A sterile room, a microbial limit room, a positive control room and an auxiliary room are required, and the inspection room is of 10,000-level cleanliness. 2. In terms of quality control, there must be institutions or full-time inspectors and inspection pharma machinery for the quality inspection of the medical devices produced; the person in charge of production, quality and technology of the enterprise should have the professional ability suitable for the medical devices produced, and master the According to the laws, regulations and rules of the state on the supervision and administration of medical devices, as well as the relevant product quality and technical regulations, the person in charge of quality shall not concurrently be the person in charge of production; there are management systems to ensure the quality of medical devices; there are after-sales services that are compatible with the medical devices produced Service ability; there are requirements that meet the requirements of product development and production process documents. Enterprises shall keep laws, regulations, rules and relevant technical standards related to the production and operation of medical devices. 2. National standards related to medical masks Ordinary medical masks implement the recommended standard of the pharmaceutical industry YY/T0969 'Disposable Medical Masks', which are generally used in ordinary medical environments and have the lowest level of protection. Medical surgical masks implement the mandatory standard YY0469 'Technical Requirements for Medical Surgical Masks' in the pharmaceutical industry, and are generally used in environments with body fluids and blood splashes, such as hospital operating rooms, with medium protection levels. Medical protective masks implement the national mandatory standard GB19083 'Technical Requirements for Medical Protective Masks', which are suitable for the protection of medical personnel and related staff against airborne respiratory infectious diseases, with a high degree of protection. 3. Materials, process and pharma machinery of disposable medical masks 1. Main materials: The face of the medical mask is divided into three layers: inner, middle and outer. The inner layer is a skin-friendly material, and the middle layer is an isolation filter layer (usually meltblown cloth). The outer layer is a special antibacterial layer. The common disposable masks on the market are made of non-woven raw materials, which need to be used: 1. PP non-woven fabric, 2. meltblown cloth, 3. nose bridge strips, 4. ear straps and other materials. 2. Production process: The production process is generally forming, ear strap welding, disinfection and sterilization, etc. Forming: mainly using the principles of ultrasonic welding and automatic edge sealing to complete the composite forming of multi-layer materials for flat masks (the mask body machine is used for automatic production. The multi-layer material flat mask finished product machine can use 1~4 layers of PP spunbond non-woven activated carbon and filter materials. The entire machine is automated in one line from raw material feeding to nose line insertion and edge sealing. operation.), multi-layer merging, indenting nose clips, folding out a laminated structure, pressing the mask flat, single cutting and sewing of the mask, and pressing the edge. Earband welding: Earband welding is a step of welding the earbands on the semi-finished masks produced by the mask machine. According to the requirements of the process, it is divided into inner ear belt type, outer ear belt type and strap type. Disinfection and sterilization: Fragile non-woven fabrics generally do not use high temperature disinfection, but use ethylene oxide, a colorless gas, to kill microorganisms. Because after sterilization with ethylene oxide, the residual ethylene oxide on the mask not only irritates the respiratory tract, but also causes carcinogens. The residual ethylene oxide must be released through analytical methods to meet the safety content standard, which is qualified after testing. After that, it can be released from the factory. A standard process for parsing and disinfection takes 7 days to half a month. Many of the disinfection links of high-end medical protective masks use radiation disinfection, which mainly uses the ability of ionizing radiation to kill pathogenic microorganisms to sterilize disposable medical supplies. It is superior to heating method and ethylene oxide chemical disinfection method. A very mature sterilization method in

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