Author: Shenzhen Zhongjing Global Purification Technology Co., Ltd.Time:2018-07-26 11:17:40Views:946
Medical devices are widely used in hospitals and other places.
First, the production process (key process) and main process of this product are: raw materials → incoming inspection → filming (key process) → process inspection → folding → welding → process inspection → small package sealing (key process) → large packaging → extinction Bacteria (special process) → Analysis → Inspection → Storage.
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.