Measures to implement GMP in production equipment

Pharmaceutical production equipment is very important for the implementation of GMP certification, and the country is also paying more attention to it, increasing the research and design capabilities of pharmaceutical production equipment, and strengthening the quality control of pharmaceutical production equipment. The implementation of GMP starts from the source of the equipment, which is the production equipment. Important measures to implement GMP: The design, manufacture and material selection of pharmaceutical production equipment should meet the requirements of no pollution to raw materials, semi-finished products, finished products and packaging materials; equipment in direct contact with medicines should be clean and smooth; easy to clean or disinfect, corrosion-resistant ;Easy to clean, sterilize and sterilize, facilitate production operation and repair and maintenance, and prevent errors or reduce errors or reduce pollution. Strengthen the verification system of pharmaceutical production equipment; perfect verification is one of the key factors to ensure the quality of drugs. Under the requirements of GMP, the design of equipment is developing towards automation and integration. The newly opened pharmaceutical machinery is designed as a multi-process combination or linkage line to reduce the pollution in the product circulation link. In the process of automatic circulation of some products, a closed device or a local 100-level purification flow and positive protection are used to prevent the contamination of the product by the outside air. For example, BOSCH Company of the Office of the People's Republic of China demonstrated a new type of in-wall laminar flow injection filling equipment. The machine is connected and mixed with the wall of the sterile room. The operating facade is only 500mm away from the wall. When the packaging specifications change, it only takes 30 minutes to replace the mold and guide rails Maintenance can be carried out in the non-sterile next door, and the sterile environment will not be affected during maintenance. It not only saves investment but also ensures the implementation requirements of GMP. The non-PVC multi-layer co-extruded film plastic bag infusion production line developed abroad integrates bag making, filling, and sealing at one time, and only needs to add qualified particles. All processes are carried out in a closed aseptic state. the possibility of contamination. The domestic large-weigherinfusion-filling intermodal transportation line is mainly made of stainless steel and consists of two parts: a bottle washer and a filling and sealing machine, which can be used separately and online. Another example is the water needle washing, drying, filling and sealing machine, and the plastic blow molding and filling machine for eye drops, etc., which are designed to avoid the pollution of famous offices. For the cleaning of equipment, the equipment of pharmaceutical enterprises is required to be easy to clean, especially when changing varieties, all equipment, pipes and containers should be disassembled and cleaned according to regulations. Pharmaceutical production enterprises must be equipped with full-time or part-time equipment management personnel, who are responsible for the basic management of equipment and establish and improve the corresponding equipment management system.
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