Selection of GMP production equipment

Equipment selection is an important part of process design. Domestic pharmaceutical companies are actively promoting GMP certification, but there is no authoritative department to certify whether domestic production of pharmaceutical machine equipment conforms to GMP. On the issue, we should adhere to the requirements of GMP, and strive to be advanced, reliable in quality, stable in operation, in line with national conditions and the actual situation of the enterprise. An important part of GMP certification compliance is equipment verification, which includes four stages of equipment installation confirmation (IQ), operation confirmation (OQ), performance confirmation (PQ) and post-production product verification (PV). The key is that the design, selection, manufacture and installation of preparation equipment must comply with GMP standards. To meet the GMP standard, the specific design of the preparation equipment should reflect the overall requirements of product production and process requirements, safety, stability, reliability, ease of cleaning, disinfection or sterilization, ease of production operation and maintenance, and prevention of errors and cross-contamination. Thought. Zhongshan Kenwei summed up the problems encountered in the actual operation of the GMP whole plant planning for many years, and shared it with you. Grooves and exposed bolted connections. The internal and external performance of the equipment should be smooth, clean, without edges and corners, no dead corners, and easy to clean and disinfect. At the same time, in order not to cause pollution outside the device, the equipment should be dust-proof, leak-proof, heat-insulating, noise-proof and explosion-proof. The selection of materials for the equipment should be strictly controlled. Corrosion-resistant material that does not react chemically with drugs, release particles or adsorb drugs. The cleaning of aseptic equipment, especially the bacteria that must be in direct contact with parts, should be equipped with cleaning-in-place (GIP), bacteria-in-place (SIP) cleaning, and bacteria-in-place series in addition to general methods. At the same time, the equipment design should also meet a series of requirements of GMP for preparation equipment in terms of installation, repair, maintenance, management and verification. The design of preparation equipment should be mechanized, automated, program-controlled and intelligent. Since the preparation industry GMP compliance is a complex series of projects, the design and manufacture of preparation equipment in my country should develop in the direction of standardization, generalization, systematization and mechatronics. , in order to achieve continuous sealing and automatic detection of the production process. GMP certification in food, pharmaceutical and other industries is very strict. Before planning and design, it is recommended to find a company with practical planning and operation experience. Zhongshan Kenwei has rich experience in GMP whole plant planning. In the world, only Kenwei can provide desiccant, deoxidizer The ability of GMP whole plant planning.