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Atkinson  


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10 October 2022




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Original Title: Reference for Production Process of Disposable Medical Mask and Construction of Purification Workshop Source: Dust-free Sterile Clean Room Expert Recently, the epidemic of novel coronavirus pneumonia has affected the sensitive nerves of Chinese people. Under the constant appeal of medical experts, people pay more and more attention to the recognition of masks. Mask is a kind of sanitary article, which is worn on the mouth and nose to filter the air entering the mouth and nose, so as to prevent harmful gases, odors and droplets from entering and leaving the wearer's mouth and nose. It is made of gauze or paper. When respiratory infectious diseases are prevalent, wearing a mask has a very good effect when working in a polluted environment such as dust. According to the statistics of the Development and Reform Commission on February 5, as of February 3, the output of masks in 22 key provinces in China had reached 14.8 million, an increase of 3.1% over the previous day, of which N95 mask had reached 116000, an increase of 48%, other medical masks had reached 9.98 million, a 36% increase, and disposable masks had reached 4.71 million. The production of masks showed a continuous upward trend. (Above) a medical device limited company produces masks. So do we know how medical disposable masks are made and under what environment? How do we choose the right masks during the epidemic? On this issue, iwuchen, with the help of customer cases, explained in detail the production and disinfection process of masks in the clean workshop of 100000 masks produced by a medical device company in Zhejiang. Full of dry goods! Great help, recommended to read after the collection oh ~ Expand the full text In terms of the way of use, masks can be divided into civil masks and medical masks. Civil masks do not need to be registered like medical masks, but can be produced by obtaining a third-party inspection report in accordance with GB/T 32610-2016. Since everyone is basically an equipment practitioner, today we will focus on medical masks. 1. According to the Classification Catalogue of Medical Devices, there are two kinds of medical masks, as shown in the following figure: 2. According to the Guidelines for Technical Examination of Medical Mask Registration issued by the State Administration, based on the intended use and scope of application of the product, it is generally divided into medical protective masks, surgical mask and disposable medical masks. Medical protective masks are suitable for medical staff and related workers to protect against air-borne respiratory infectious diseases. Surgical mask are intended for basic protection of medical staff or associated personnel, as well as protection against the transmission of body fluids and splashes during invasive procedures. Disposable medical masks are suitable for the hygienic care of the wearer in a general medical environment where there is no risk of body fluids and splashes. In fact, you can see that there is no disposable medical mask in the Guidelines for Registration and Technical Review of Medical Mask Products. Which category does it belong to? According to the latest classification of medical devices, it is classified as 141400, which belongs to the protective equipment of medical staff and is a second-class medical device. From this we can see that all medical masks belong to Class II medical devices. If we want to produce masks, we must carry out corresponding design and development,Medical Disposable Coverall, produce samples under GMP conditions, compile product technical requirements according to the Measures for the Registration and Management of Medical Devices, send them to registration inspection, prepare registration data and register products. Because they are exempted from clinical use, they are listed in the catalogue. Therefore, it is not necessary to conduct clinical trials, but it is necessary to conduct clinical evaluation and submit a comparative description of the declared products and similar products already on the market. The comparison description shall include the working principle, product material, structure and composition, main technical performance indicators, disinfection/sterilization methods,KN95 Face Mask with Five Layers, intended use, household use, etc. Production process of disposable medical mask: 1, selecte raw materials: selecte a proper amount of PP non-woven fabric, nose bridge strip, silk thread, anti-bacterial filter paper, activate carbon cloth, waterproof breathable film, non-woven fabric edge wrapping material and ear band. 2. Film production: PP non-woven fabric raw materials, anti-bacterial filter paper, activated carbon cloth and waterproof breathable film are hung on the material rack of the mask film machine, and the machine is debugged for automatic production. And 3, weld and forming: place that nose bridge strip above the mask sheet, and then folding the mask sheet and wrapping the nose bridge strip. 4. Inner packing workshop: sterilize and vacuum pack the molded mask. 5. Outsourcing shipment: Integrate the packaged masks into the external packaging for shipment. Production process of medical cup-shaped protective mask: Selection of raw materials > Hot pressing and shaping > Manufacturing of outer mask > Welding and trimming > Printing of mask label > Breathing valve punching > Nose bridge strip welding > Manual/machine sticking of inner nose bridge strip > Welding of ear strap > Welding of breathing valve > Finished product inner packaging workshop > External integrated packaging > Storage/shipment (Above) Disposable medical mask Mask production environment and requirements Friends who are familiar with the classification of medical devices should know that medical devices are divided into three categories. Masks belong to the second category of medical devices. Whether it is a medical cup-shaped protective mask or a disposable medical mask, the production environment must be in a clean workshop of 100000 or above. This is a mandatory requirement of the state. The production environment must be dust-free and sterile. Masks with special requirements must be produced within the specified constant temperature and humidity range. (Above) Masks are produced under the 100,000-level clean workshop. Logistics: from the initial selection of raw materials to the final molding package, the whole process must be dust-free and sterile. The workshop layout should be reasonable, the process flow should be smooth, the connection between the upper and lower processes should be smooth, the transportation distance should be short and straight, and the circuitous and round-trip transportation should be avoided as far as possible. The following figure shows the mask production process and room layout of the 100, Full Body Disposable Coverall ,Full Body Disposable Coverall,000-level purification workshop (D-level purification workshop) of a medical device company in Zhejiang. (Above) Logistics schematic diagram of mask production workshop of a medical device company in Zhejiang Production process and equipment of medical mask Personnel: from changing clothes > hand washing and disinfection/buffering > air shower disinfection > clean corridor > each clean workshop must be dust-free. The following figure is a schematic diagram of personnel flow of a medical device company in Zhejiang. (Above) Schematic diagram of personnel flow in the mask production workshop of a medical device company in Zhejiang Production and use after passing the third party inspection After the decoration of the purification workshop is completed, it needs to pass the third-party professional testing before it can be produced and used. Dust-free (dust particle detection) Sterilization test Illuminance detection How to choose the right mask? During the epidemic period, we will teach you how to choose the right mask, not to over-protect, so that emergency supplies can play the greatest role. Medical mask production line equipment Medical masks are generally sterile, of which disposable medical masks are sterile and non-sterile, and other medical masks are sterile products, which should be produced in 100000 sterile clean workshops, whose requirements are more stringent, and there should be air conditioning purification system and purified water system from raw materials into the factory. The manufacturing can be completed after forming, pressing, edge cutting, breathing valve welding (if any), ear band spot welding, nose bridge line fitting, breathing valve punching (if any), packaging, sterilization and analysis (EO sterilization). Full-automatic one-driving-two mask production equipment In order to realize the above manufacturing process, it is necessary to configure fully automatic production equipment or semi-automatic production equipment. Fully automatic equipment is integrated, generally one body machine tows two to three ear belt machines, which can be realized from raw material feeding to packaging completion. The semi-automatic equipment shall be configured one by one according to the above process, including mask forming machine, mask laminating machine, mask trimming machine, breather valve punching machine, nose bridge line laminating machine, ear band spot welding machine, breather valve welding machine, etc. Sterilization of medical masks For the production of medical sterile masks, they must pass the sterilization process before they can be released. This is undoubtedly a threshold for cross-border entry into the mask industry. Sterilization can be entrusted or self-sterilized by purchasing sterilization equipment. Ethylene oxide (EO) sterilization and irradiation sterilization are commonly used in the market. Considering that poor irradiation sterilization dose control will affect the filtration efficiency of melt-blown cloth, which will lead to the filtration efficiency not meeting the requirements, most enterprises choose EO sterilization. Because EO sterilization uses toxic and harmful ethylene oxide, it needs to be analyzed after sterilization, which is divided into natural analysis and sterilization cabinet analysis. Generally speaking, the natural resolution cycle is about 14 days to ensure that the residual ethylene oxide in the mask is up to the standard. Testing requirements for medical masks The inspection of medical mask products includes factory inspection and type inspection. The factory inspection items shall at least include the following items: requirements for appearance, structure and size, nose clip, mask belt, microbial indicators, and ethylene oxide residue (if ethylene oxide sterilization is used). The type inspection shall be the full performance inspection of the product standard. The main performance indicators of related masks are as follows: With regard to microbiological indicators, the sterilization mask should be sterile after being sterilized by ethylene oxide, and the residual amount of ethylene oxide should not exceed 10 μg/G. Non-sterile respirator (general grade) shall meet the requirements in the following table. Microbial indicators of masks Other issues related to medical masks 1. In view of the fact that it is difficult to control the quality of filter materials for medical masks through convenient and effective inspection methods at present, the standardized operation of the production quality management system is the main means for enterprises to ensure the stable quality of mask products. Therefore, auditors and inspectors will pay attention to the production process and supply source of filter materials in the registration technical review and system assessment. Enterprises should control the filter materials of products, clarify the source and quality requirements of filter materials, and have relatively stable production processes and supply sources to ensure the quality of products. (www.iwuchen.com) 2. Medical masks are Class II medical devices and should go through the registration procedure. Under the condition of epidemic situation, some provinces can carry out record management, such as Guangdong Province, which clearly intends to carry out the registration and production of medical masks, protective suit and other products belonging to Class II prevention and control devices during the first-level response period, and applies to the local Municipal Food and Drug Administration for record based on the opinions of the industry and information department. The Municipal Bureau shall indicate in the record certificate that "this record is only applicable during the first-level response period of public health events". After filing, release according to the following method: carry out sterility test according to the 1101sterility test method in the third part of the Chinese Pharmacopoeia (2015 edition), and release first if no microbial growth is found after seven days of culture and other physical and chemical indicators are qualified. The starting time of use shall be marked on the product label according to the completion time of normal sterility test. Enterprises should recall in time if they find that they do not meet the requirements during the follow-up culture and observation period of sterility test. 3. The safety and effectiveness of medical masks are only part of the factors that play a protective role. The correct use and wearing method of masks also directly affect the effect of protection. Therefore, all the information needed by users should be clearly stated in the instructions to avoid misuse of masks and reduce the risk of cross infection. Such as indicating the wearing method, clearly identifying the front and back of the mask, suggesting the time of use, indicating the level of filter material or related instructions, etc. In addition, medical staff do not have a clear understanding of the scope of application of different types of medical masks, so they should clearly indicate the scope of application of masks in the instructions and strengthen the training of medical staff. 4. Sterile medical masks are produced under the conditions of Class 100,000 clean workshops, which are characterized by the maximum allowable number of dust particles. The number of particles larger than or equal to 0.5 microns shall not exceed 3500000, and the number of particles larger than or equal to 5 microns shall not exceed 20000. In addition, the maximum allowable number of microorganisms, the number of floating bacteria shall not exceed 500 per cubic meter; the number of settling bacteria shall not exceed 10 per Petri dish. At the same time, the pressure difference of clean rooms with the same cleanliness level should be consistent. The pressure difference between adjacent clean rooms with different cleanliness levels should be ≥ 5 Pa, and the pressure difference between clean rooms and non-clean rooms should be ≥ 10 Pa. This is mainly to ensure that the air flows from the clean area to the non-clean area and avoid the backflow of airflow. Wen The temperature is generally controlled at 20-22 ℃ in winter and 24-26 ℃ in summer, with a fluctuation of ± 2 ℃. The humidity of the clean room is controlled at 30-50% in winter and 50-70% in summer. When there is no special requirement for temperature and humidity,Medical Full Body Coverall, it is better to wear clean work clothes without feeling comfortable. Its functional layout, equipment and facilities and management requirements can be referred to the Guide to the Key Points of Medical Device Clean Room (Area) Inspection. Relevant standards applicable to medical masks Medical mask products should apply the following standards according to their own characteristics, but not limited to quoting the following standards: Return to Sohu to see more Responsible Editor:. zjyuan-group.com

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