Purification workshop GMP requirements for equipment?
Purification workshop GMP requirements for equipment?
The design, selection and installation of equipment in the purification workshop should meet production requirements, be easy to clean, disinfect and sterilize, facilitate production operation and repair and maintenance, and prevent errors or reduce pollution; the equipment in direct contact should be clean and smooth , easy to clean or sterilize, corrosion-resistant, design...
Text label: Purification workshop engineering, GMP workshop engineering, equipment requirements, Zhongjing Global Purification
What are the requirements of GMP for purification workshop?
The design, selection and installation of equipment in the purification workshop should meet production requirements, be easy to clean, disinfect and sterilize, facilitate production operation and repair and maintenance, and prevent errors or reduce pollution; the equipment in direct contact should be clean and smooth , easy to clean or sterilize, corrosion-resistant, and 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 when the oil, coolant, etc. leaks; the preparation, storage and distribution of purified water and water for injection should be To prevent the growth and contamination of microorganisms, the materials used for storage tanks and conveying pipelines should be resistant to corrosion. The design and installation of pipelines should avoid dead corners and blind pipes. Cleaning and sterilization cycles should be specified for storage tanks and pipelines. Equipment for crushing, sieving, mixing, granulating, drying, coating, etc. should be equipped with dust-catching, powder-absorbing devices and dust-proof curtains locally; drying air, compressed air, inert gas, etc. that are in direct contact with drugs should be equipped with purification equipment After purification treatment of the device, the particles and microorganisms contained in the gas must meet the specified air cleanliness requirements, and the air outlet of the drying equipment must have measures to prevent air backflow.
When the installation of equipment such as linkage lines and double-door sterilizers need to pass through two areas with different cleanliness levels, appropriate sealing methods should be adopted while installing and fixing to ensure that areas with high cleanliness levels are not affected; Between rooms with different cleanliness levels, if a conveyor belt is used to drive materials, in order to prevent cross-contamination, the conveyor belt should not pass through the partition wall, but it should be conveyed in sections on both sides of the partition wall, and the conveyor device sent to the sterile area must be conveyed in sections; The installation of transmission machinery should add anti-vibration and noise reduction devices to improve the operating environment. During dynamic testing, the noise in the purification workshop should not exceed 70dB; design or select light and flexible transmission tools, such as conveyor belts, trolleys, launders, flexible pipes, closed hoppers etc., to assist the connection between the equipment; the equipment should be installed in the appropriate position of the pharmaceutical cleanroom, between the equipment and other equipment, walls, ceilings and floors; there should be an appropriate distance to facilitate production operations and maintenance. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for purification workshops and purification projects.
The cleaning procedures of the equipment should follow: there are clear washing methods and washing cycles; clear cleaning verification methods for key equipment; the cleaning process and post-cleaning inspection data must be recorded and saved; some movable equipment can be moved to The cleaning area is cleaned and sterilized; the cleaning of sterile equipment, especially the parts that directly contact the medicine, must be sterilized, and the sterilization date should be marked. If necessary, microbiological verification should be carried out. The sterilized equipment should be used within three days; When the same equipment continuously processes the same sterile product, it should be cleaned and sterilized between batches. When the same equipment is processing the same non-sterile product, it should be thoroughly cleaned at least once a week or every three batches produced according to the cleaning procedures. For the use of equipment and instruments, the enterprise should formulate special personnel to formulate standard operating procedures and safety precautions. The operators need to be trained and assessed, and can only be operated when they are confirmed to be mastered; equipment maintenance and repair procedures should be formulated to check the lubrication of the equipment. Ensure that the equipment is always in good condition without running, running, dripping or leaking; unqualified equipment should be moved out of the production area, and there should be obvious signs before it is moved out.
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