Medical devices are widely used in IVD to refer to products and services that obtain clinical diagnostic information by detecting tissues and secretions such as blood and other substances outside the human body. The “test” in the “test and inspection” commonly used in hospitals in China includes most subdivisions of IVD—such as 1 clinical chemistry, 2 immunoassay, 3 molecular diagnosis (MDx), and elemental diagnosis. , microbiological diagnosis, urine diagnosis, blood coagulation diagnosis, tissue diagnosis, hematology and flow cytometry. The first three categories are the mainstream IVD methods for medical institutions in China.

requirements

1. Enzyme-linked adsorption assay reagents, fluorescent reagents, luminescent reagents, polymerase chain reaction (PCR) reagents, gold standard reagents, dry chemical reagents, cell culture media, calibrators and controls, enzymes, antigens, antibodies, and Processes such as liquid preparation, coating, dispensing, filming, drying, cutting, filming, and inner packaging of other active components and at least 100,000 purification environments should be carried out. . The dispensing of sterile materials must be in the local level. The production of common chemical diagnostic reagents should be carried out in a clean environment.

2, YY 0033-2000 sterile medical device production management specifications; 2, YY / T 0567.1-2005 aseptic processing of medical products 3, YY / T 0567.2-2005 aseptic processing of medical products 4, GB 50457-2008 Pharmaceutical industry clean factory design specification

Third, the requirements of temperature and humidity 1, with the requirements of the production process. 2. When there is no special requirement in the production process, the clean room (area) with air cleanliness of 100,000 grades should be 18 °C ~ 26 °C, the relative humidity should be 45% ~ 65%; the air cleanliness is 100,000, thirty Class 10,000 clean room (zone) temperature should be 18 ° C ~ 26 ° C, relative humidity should be 45% ~ 65%. When there are special requirements, it should be determined according to the process requirements. 3. The temperature of the personnel purification room should be 16 °C ~ 20 °C in winter and 26 °C ~ 26 °C in summer. Including: partition wall, ceiling, floor, purification, air conditioning, fire protection, pure water pipeline, pressure difference.

Fourth, the test content: temperature and humidity, cleanliness, pressure difference, gas exchange times, sedimentation bacteria

Zhongjing Global is committed to the design and construction of the GMP workshop for medical device purification workshops, serving many second-class and three-category medical device companies.