The list of high-quality authors will continue to popularize the relevant knowledge of sterile inspector training for everyone, and today I will talk about the principles of setting the cleanliness level of the clean room (area) for you, and look at the text together.
Principles for setting cleanroom (area) cleanliness levels
1.Production technology that minimizes contamination is used to ensure that medical devices are free from contamination or can effectively remove contamination. Advocate technological progress and recommend advanced production technology. Including advanced production technology, advanced equipment, tooling and facilities. Minimize the human factor in the production process, maximize the product from being exposed to the operating environment, and avoid direct contact between people and the product as much as possible.
2.Implantation and intervention of intravascular instruments, processing of parts without cleaning, final cleaning, assembly, primary packaging and sealing, not less than 10,000 grades. Implantation into human tissues, direct or indirect contact with blood, bone cavity or unnatural orifice, (non-cleaning) parts processing, final cleaning, assembly, primary packaging and sealing, etc., not less than 100,000 grades. Devices in contact with human damaged surfaces and mucous membranes, (not cleaned) parts processing, final fine washing, assembly, primary packaging and sealing, not less than 300,000 grades.
The primary packaging materials that are in direct contact with the use surface of sterile medical devices and are used without cleaning should follow the principle of the same cleanliness level as the production environment of the product, so that the quality of the primary packaging materials meets the requirements of the packaged sterile medical devices. If the primary packaging material is not in direct contact with the surface of the sterile medical device, it shall not be less than 300,000 grade. For processing with requirements or aseptic operation technology, in a local Class 100 clean room (area) below class 10,000. The air cleanliness level of the area where clean work clothes are washed, dried and the final cleaning and disinfection of clean work clothes rooms and special workstation equipment can be one level lower than that of the production area.
The medical device regulations stipulate that high-risk bioactive materials (such as highly virulent microorganisms, sporum products, hormone reagent components, and radioactive substances) should be operated using a separate air purification system, and negative pressure should be maintained with adjacent areas, and the exhaust air should not be recycled; The handling of negative and positive serum, plasmids or blood products should be carried out in an environment of at least 10,000 grades, with relative negative pressure in adjacent areas and in accordance with protective regulations; The clean environment for the production of hormone reagent components shall adopt an independent and dedicated air purification system, and the purified air shall not be recycled; The operation area of highly toxic microorganisms and spores products should maintain a relative negative pressure with the adjacent area, and be equipped with an independent air purification system, and the exhaust air should not be recycled. Enzyme-linked immunosorbent assay reagents, immunofluorescence reagents, immunoluminescence reagents, polymerase chain reaction (PCR) reagents, gold standard reagents, dry chemical reagents, cell culture media, calibrators and quality controls, enzymes, antigens, antibodies and other active components of the preparation and packaging of other products, such as liquid preparation, coating, packaging, point film, drying, cutting, filming, and inner packaging, on-site verification, at least should be operated in a 100,000-level clean environment, The dispensing of sterile materials must be carried out in a local Class 100 clean environment.
In principle, the sterile laboratory should be equipped with three local 100-level clean rooms (areas) under the 10,000-level level, which are used as the sterility testing room, the positive control room and the microbiological limit room. The sterility laboratory should be set up separately from the clean production area, with an independent area, a separate air purification system, a dedicated logistics channel and an experimental preparation area. The positive control room should be equipped with a biological safety cabinet not lower than the requirements of "Biological Safety Cabinet" (GB 41918-2022) and "Level Biological Safety Cabinet" (YY 0569-2011).
Production enterprises can post a clean room (area) floor plan at the entrance of the clean room (area) to identify the layout of the clean room (area), the level of environmental control and the direction of logistics.
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