Author: Shenzhen Zhongjing Global Purification Technology Co., Ltd.Time:2018-07-26 11:47:42Views:1558
First, the pharmaceutical packaging materials include: medicinal butyl rubber stopper, PTP aluminum foil for pharmaceutical packaging, medicinal PVC hard sheet, medicinal plastic composite hard sheet, composite film (bag), plastic infusion bottle (bag), solid, liquid Medicinal plastic bottles, plastic eye drops bottles, ointment tubes;
Second, the requirements for the production of clean room (area) for pharmaceutical packaging materials 1. The production of packaging materials and containers (hereinafter referred to as "medical packaging materials") that directly contact drugs should be reduced to a low level. When considering the cleanliness level of the production environment, it should be combined with production technology. When the production technology can not guarantee that the drug packaging material is not polluted or can not effectively eliminate the pollution, the cleanliness of the production environment should be as high as possible under the premise of the conditions. Second, the pharmaceutical packaging material production enterprise can determine the corresponding cleanliness level according to the classification and use of the product. The clean level setting should follow the same principle as the cleanliness level of the packaged pharmaceutical production, and according to the production process of the pharmaceutical packaging material. Purify the design and construction of the plant to ensure that the product is produced in a compliant environment. 3. When there are multiple processes in the clean room (area), different cleanliness levels should be adopted according to the different requirements of each process. Under the conditions that meet the requirements of the production process, the airflow organization of the clean room (area) can be combined with the partial work area air purification and the whole room air purification, such as the local 100-level clean area under 10000. 4. Compressed air or various gases used in clean rooms (areas) should also be included in the controlled range. 5. Washing and drying of clean work clothes and cleaning and storage of tools shall comply with the corresponding provisions in the “Good Manufacturing Practices” (2010 Revision). The storage of sterile work clothes and storage after sterilization shall be in Class 10,000 clean rooms (areas). 6. Different levels of cleanliness should be set separately for changing clothes and changing shoes. In order to enter the sterile core area, personnel and process materials should be preferentially selected through several stages of cleanliness to adapt to the different requirements of the area they are entering. 7. The production area of pharmaceutical packaging materials enterprises can be divided into production control areas and clean rooms (areas). The production control area should be a confined space with a concentrated air supply system with coarse filtration. The inner surface should be smooth and smooth.