Construction Standards for Sterile GMP Dust - Free Workshop for Mask Production
2025.02.12
In the present, masks, as important protective supplies, have crucial requirements for their production environment. The construction of a sterile GMP dust - free workshop for masks is directly related to the quality and safety of masks. Today, Guangzhou Cleanroom Construction Co., Ltd. will take you to deeply understand the construction standards for a sterile GMP dust - free workshop for masks.
I. The Importance of Sterile Mask Production
Masks serve as a key defense line for preventing respiratory infectious diseases and blocking harmful particles and microorganisms. Their sterility directly affects the protective effect. In the context of the normalization of epidemic prevention and control, ensuring sterile mask production is the foundation for safeguarding public health. Masks produced in a sterile environment can effectively reduce the risk of microbial contamination, making users more assured.
II. Interpretation of GMP Standards
GMP (Good Manufacturing Practice) is the Good Manufacturing Practice for pharmaceutical production. It requires comprehensive control over personnel, equipment, environment, materials, production processes, etc. during the production process to ensure product quality and safety. Although masks are not pharmaceuticals, producing them by referring to GMP standards can significantly improve the quality of masks. For example, in personnel management, personnel entering the workshop must go through strict disinfection and changing procedures to avoid carrying microorganisms into the production area.
III. Classification of Dust - Free Workshop Grades
Dust - free workshops are classified according to the number of dust particles and microorganisms in the air. For mask production, a cleanliness level of class 100,000 or even higher is generally required. A class 100,000 dust - free workshop means that the number of dust particles with a particle size greater than or equal to 0.5 microns per cubic meter of air does not exceed 3,520,000, the number of dust particles with a particle size greater than or equal to 5 microns does not exceed 29,300, the maximum allowable number of microorganisms is 500 floating bacteria per cubic meter, and 10 sedimentation bacteria per petri dish.
IV. Specific Construction Standards for Sterile GMP Dust - Free Workshop for Masks
1. Workshop Layout: Functional areas should be reasonably divided, including raw material storage areas, production areas, semi - finished product temporary storage areas, finished product inspection areas, and packaging areas, etc. There should be clear separations between various areas to prevent cross - contamination. For example, the raw material storage area should be kept dry and well - ventilated to avoid the raw materials from getting damp, deteriorating, or being contaminated by microorganisms.
2. Air Purification System: This is the core part of the dust - free workshop. The air needs to be filtered at multiple levels through primary, medium - efficiency, and high - efficiency filters to ensure that the air entering the workshop reaches the specified cleanliness level. At the same time, a reasonable air flow organization should be ensured in the workshop. Generally, the top - supply and bottom - return or side - supply and side - return methods are adopted to avoid air flow dead corners and prevent the accumulation of dust particles and microorganisms in the workshop.
3. Treatment of Ground and Wall: The ground should be made of anti - static, wear - resistant, and easy - to - clean materials, such as epoxy self - leveling floors. The walls should be smooth and flat, and materials that are not easy to accumulate dust and are convenient for cleaning and disinfection, such as color - coated steel plates, should be used. The corners of the walls should be rounded to reduce dust accumulation and cleaning dead corners.
4. Management of Personnel and Material Entry and Exit: Personnel must pass through an air shower room to remove dust particles on their bodies before entering the workshop. Before materials enter the workshop, they should be cleaned and disinfected and enter through a transfer window to avoid bringing external pollutants into the workshop.
Guangzhou Cleanroom Construction Co., Ltd. specializes in the production of purification equipment. We are well aware of the strictness of the construction standards for a sterile GMP dust - free workshop for masks. Our products and solutions can help enterprises build dust - free workshops that meet the standards and provide reliable guarantees for mask production. If you have relevant needs, please feel free to contact us at any time.
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