GMP stipulates that the production of preparations, fine drying bags of APIs, raw and auxiliary materials used in preparations, and packaging materials directly in contact with medicines should be carried out in clean areas.
The clean room or clean area of a pharmaceutical manufacturing enterprise refers to the area where the specified environmental control is required for dust particles and microbial contamination.
Its building structure, equipment and its use all have the function of reducing the intervention, generation and retention of pollution sources in the area, so the clean room of drug production enterprises has its own characteristics.
Controlling dust particles and microorganisms in the environment is equally important to the clean room of pharmaceutical manufacturing companies. Dust particles, in particular, the existence of direct quality of dust particles and parasitic microorganisms endanger people's lives.
When designing a clean room for a pharmaceutical production enterprise, it is necessary to make necessary regulations for the links that may generate particles and dust, such as interior decoration, ambient air, equipment, etc., in addition, it is necessary to purify the personnel and materials entering the clean room.
Microorganisms refer to bacteria and fungi that can be produced anywhere and have strong reproductive capacity. Most of the microorganisms in the air are attached to the dust, and some are suspended in the air in the form of spores.
Since the microorganism is constantly growing and multiplying, it is a "living particle". Under suitable temperature conditions. They can multiply 21-24 times 10 times a day and night. Therefore, the control of microorganisms is particularly important.
The pollution to the unemployed pharmaceuticals is mainly dust, bacteria, viruses, pyrogens, and allergic substances. If the injection drug is contaminated with bacteria, it will cause local redness, swelling and pus, and it may cause systemic bacterial infectious diseases. There are Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, live mites and mites, and mold and miscellaneous bacteria are also restricted.
It is for these reasons that pharmaceutical manufacturing cleanrooms must control both particulates and microorganisms in the manufacturing environment. Hardware such as workshops and equipment which are necessary conditions for drug production, must also be considered and satisfied from this aspect.
Suzhou Pharma Machinery Co.,Ltd.