Pharmaceutical factory dust-free workshop process requirements
1. The clean room of the pharmaceutical factory determines the corresponding cleanliness level according to the classification and use of the products that can be produced by the company. The setting of the cleanliness level should follow the same principles as the cleanliness level of the packaged medicines to ensure that the products meet the specified environment. produced in. The compressed air or various gases used in the dust-free workshop of the pharmaceutical factory should also be included in the controlled scope. 2. The production area of u200bu200bthe dust-free workshop of the pharmaceutical factory can be divided into the production control area and the clean room (area). The production control area should be a closed space with a centralized air supply system with coarse filtering. The inner surface should be smooth and free of particles falling off. , walls and floors can withstand cleaning and disinfection to reduce dust accumulation. 3. If there are multiple processes in the dust-free workshop of the pharmaceutical factory, 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 of the pharmaceutical factory can be combined with air purification in the local working area and air purification in the whole clean room modular, such as the local Class A clean area under Class C. 4. The dust-free workshop of the pharmaceutical factory should be equipped with an air-conditioning purification system according to the production varieties, production operation requirements and external environmental conditions, so as to effectively ventilate the production area, and have temperature, humidity control and air purification and filtration to ensure the production environment of the dust-free workshop of the pharmaceutical factory. meet the requirements. The pressure difference between the clean area and the non-clean area, and between the clean areas of different levels should not be less than 10 Pascals, and a pressure difference gauge should be installed between the adjacent levels of the pressure difference. The pressure difference data in the clean clean room modular of the pharmaceutical factory should be recorded regularly or included in the relevant documents. When necessary, an appropriate differential pressure gradient should also be maintained between different functional areas (operating rooms) of the same cleanliness level. 5. The clean room of the pharmaceutical factory should design the dressing room according to the air lock method, so that the different stages of dressing are separated, and the work clothes are prevented from being contaminated by microorganisms and particles as much as possible. The locker room should have adequate ventilation. The static level of the rear section of the locker room shall be the same as that of its corresponding clean area. The hand washing facility in the clean room of the pharmaceutical factory can only be installed in the first stage of changing clothes. 6. The cleanliness level setting of the production clean area in the clean room of the pharmaceutical factory should follow the same principles as the cleanliness level of the packaged medicines, such as oral liquid and solid preparations, cavity medicines (including rectal medicines), epidermal medicines. Non-sterile preparations such as external medicines should be set according to the requirements of Class D clean area in the appendix of 'Sterile Medicines'. The manufacturer shall take appropriate microbial monitoring measures for the clean clean room modular area according to the standards and characteristics of the product. 7. The clean area required for the production of the dust-free workshop of the pharmaceutical factory can be divided into the following 4 levels: A, B, and C. Class D. 8. Dynamically monitor the microorganisms in the dust-free workshop of the pharmaceutical factory to evaluate the microbial status of aseptic production. Monitoring methods include sedimentation bacteria method, quantitative air planktonic bacteria sampling method and surface sampling method (such as cotton swab method and contact dish method). 9. The design of the clean area of u200bu200bthe clean room of the pharmaceutical factory must meet the corresponding cleanliness requirements, including the 'static' and 'dynamic' standards. Static refers to a state where all production equipment is installed, but there is no production activity and no operators are present. Dynamic refers to the state in which the production equipment runs in a predetermined process mode and has a specified number of operators operating on site.
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