1, clean room requirements: drug production enterprises need to comply with the standards of drug production of clean room, including strict disinfection, ventilation, purification, testing and other requirements. While the clean room of the pharmaceutical package production enterprises only need to comply with the standards of the production of pharmaceutical packages.
2, the degree of cleanliness: the clean room of the pharmaceutical production enterprises require more, generally need to reach 10,000 or higher clean level, in order to ensure that the pharmaceutical production process of quality control and stability of drug quality. The clean room of the pharmaceutical package production enterprises only need to reach the level of purification can be, usually using 100,000 or 200,000 purification equipment.
3, the production process: the clean room of the pharmaceutical production enterprises need to be strictly in accordance with the drug production process for production, including the selection of raw materials, processing, inspection, packaging and other steps. And the clean room of the pharmaceutical package production enterprises only need to carry out the preparation of raw materials, processing, packaging and other steps.