Analysis of common problems in medical device production quality management norms
1. Which in vitro diagnostic reagent products need to be produced in a clean environment.
According to the requirements in Appendix A of the "In vitro Diagnostic Reagent Production Regulations", "Environmental and Control Requirements for Purification Workshops for In Vitro Diagnostic Reagent Production", the following in vitro diagnostic reagent products and their production processes should be in a clean environment.
1.1 The handling of negative, positive serum, plasmid or blood products should be carried out in at least 10,000 atmospheres while maintaining a relative negative pressure with adjacent areas and complying with the protective regulations.
1.2 enzyme-linked immunosorbent assay reagents, immunofluorescent reagents, immunoluminescent reagents, polymerase chain reaction (PCR) reagents, gold standard reagents, dry chemical reagents, cell culture media, calibrators and controls, enzymes, antigens, Processes such as dispensing, coating, dispensing, filming, drying, cutting, filming, and inner packaging of products such as preparation and dispensing of antibodies and other active components should at least be cleaned at 100,000 levels. In the operation. The dispensing of sterile materials must be in the local level.
2. Whether the process water used by the in vitro diagnostic reagent manufacturer can be purchased.
The in vitro diagnostic reagent manufacturer shall determine the standard of process water. If the laboratory uses Class I, Class II or Class III water, the standards shall comply with the requirements of the Analytical Laboratory Water Specifications and Test Methods. In accordance with the relevant requirements in the current version of the Pharmacopoeia of the People's Republic of China, process water should be prepared by itself and must not be purchased .
3. Whether the blood filter, liquid filter membrane, air filter membrane, pellets and other accessories and raw materials for out-of-use sterile medical device products are managed in accordance with medical devices.
Disposable sterile medical device products, blood filter, liquid filter membrane, air filter membrane, pellets and other accessories and raw materials are not managed according to medical equipment, no need to apply for corresponding medical equipment Certificate of Registration.
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