GMP requirements for preparation equipment

In the era of rapid development of the domestic pharmaceutical industry, there are many types of pharmaceutical equipment, and the development of preparation equipment is characterized by the development of airtight, high-efficiency, multi-functional, continuous and automated levels. Because of closed production and multi-functionalization, in addition to improving production efficiency, saving energy, and saving investment, it is more important to meet GMP requirements, such as attaching various pollution that may be caused by the production process to drugs and their possible impact on human health. Therefore, the equipment selection and management of pharmaceutical companies are closely related to product quality and the implementation of GMP. GMP requires the following requirements for preparation production equipment: 1. The design, selection and installation of the equipment should meet the production requirements; it is easy to clean, disinfect and bacteria, and it is convenient for production operation and maintenance; maintenance, and can prevent errors or reduce pollution. 2. Equipment in direct contact with medicines should be clean, smooth, easy to clean or sterilize, resistant to corrosion, and not subject to chemical changes or adsorption of medicines. The transmission parts of the equipment should be well sealed to prevent the contamination of raw materials, semi-finished products, finished products and packaging materials caused by leakage of lubricating oil and coolant. 3. The preparation, storage and distribution of purified water and water for injection should be able to prevent the growth and contamination of microorganisms. The materials used for storage tanks and conveying pipelines should be non-toxic and corrosion-resistant. Design and installation of pipelines should avoid dead ends and blind pipes. Tanks and piping requirements specify cleaning and sterilization cycles. 4. The operation of equipment installation, repair and maintenance shall not affect the quality of the product. 5. For equipment with a large amount of dust in production, such as crushing, sieving, mixing, granulating, drying, coating and other equipment, it is advisable to locally design dust catchers, powder suction devices and dustproof curtains. 6. In the production of sterile drugs, the equipment, containers, pipelines, valves, delivery pumps, etc. that come into contact with the medicinal liquid should be made of high-quality corrosion-resistant materials. Absorbs liquid components and releases foreign matter. The use of filters containing asbestos is prohibited. 7. Drying air, compressed air, inert gas, etc. that are in direct contact with drugs should be equipped with purification devices. After purification, the particles and microorganisms contained in the gas should meet the specified air cleanliness requirements. The air outlet of the drying equipment should be equipped with a device to prevent the backflow of air. 8. In addition to meeting the above requirements, the equipment in the sterile clean room should also meet the needs of sterilization.