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Do biosafety cabinets have to be placed in a clean area?
Do biosafety cabinets have to be placed in a clean area?At present, it is increasingly common for medical device manufacturers to install biological safety cabinets. Why is there a craze for installing biological safety cabinets?The reason is that since the introduction of the Medical Device Production Management Specifications in 2015, BSL-2 laboratories have been explicitly required to configure biological safety cabinets of level 2 or above, including A2 and B2 type biological safety cabinets. So, should biological safety cabinets be placed in a clean area? Do you need a direct row? The exhaust air of the safety cabinet is filtered and discharged. Therefore, in theory, biological safety cabinets are safe. Therefore, safety cabinets from foreign medical device manufacturers can be placed directly in ordinary areas, but they must strictly follow biosafety regulations. For operation, all biohazardous materials must be operated in a biological safety cabinet and need to be packaged and processed before being taken out. Currently, biosafety cabinets used for positive testing in China must be placed in a clean area. Regarding the issue of whether to have external direct discharge, it is only a suggestion in the "Biosafety Laboratory Building Design Code", but in domestic GMP inspections, some inspections will require direct discharge. |
