Cleanroom workshop production process validation
Cleanroom workshop production process validation
Clean clean room modular production process verification is the verification of the local or overall functions, quality control methods and process conditions of the production environment and equipment where the production line is located after completing the identification and quality control of workshops, equipment and facilities, and verification by the measurement department; Eye drops are available in glass and plastic bottles...
Text label: Validation of clean room production process, design and installation of clean clean room modular
Production process validation in clean room workshop
Clean room production process verification is the verification of the local or overall functions, quality control methods and process conditions of the production environment and equipment where the production line is located after completing the identification and quality control of workshops, equipment and facilities, and verification by the measurement department; Eye drops are packaged in glass bottles and plastic bottles. Plastic bottles are the most common. The container is best produced in the same production environment, which is not easy to be polluted, and can also reduce the cleaning, drying and sterilization of the container. Process; in production, ethylene oxide gas with strong sterilization and penetrating power is often used for sterilization of plastic containers; filter tools for filtration and sterilization, storage tanks for filtrate and key components of filling machines For sterilization, high-pressure steam sterilization is commonly used, and aseptic assembly and operation are performed; for the sterilization of the production environment, the method of formaldehyde gas fumigation is commonly used, and some use the powerful oxidation of ozone to sterilize the production environment, containers, etc. .
Sterilization process verification, select biological indicators that can resist the sterilization process; investigate the effects of various variables on the tolerance of biological indicators; establish quantitative indicators of biological indicators destroyed during the sterilization process; determine the sterilized The possibility of a substance being sterile under specified process conditions. Each sterilization process must be verified by biological indicators. Except for the filtration method, the commonly used biological indicators are spores, because in unfavorable environments, spores have stronger survivability than ordinary bacteria. Both oxyethane and radiation sterilization use the spores of Gram-positive bacteria as biological indicators. Composition of ethylene oxide gas sterilization device: sterilizer, door and connecting device, pipeline; thermometer, pressure gauge, hygrometer, recorder safety valve, etc.; manual or automatic control device such as valve or sterilization timer, etc. ; Gas introduction device, exhaust device. Performance confirmation of the sterilization device: measure the temperature distribution of the empty kettle and full load, set the monitoring point of the sterilization cycle, and confirm the reproducibility of the temperature distribution; confirm the sterilization effect with biological indicators; set the humidification method and relative humidity range , The general humidity range should be set at 40%-60%. Before sterilizing with ethylene oxide gas, the kettle is usually evacuated first, and then humidified by steaming. After reaching the set range, leave it for a certain time Introduce ethylene oxide gas; determine the cleaning method in the sterilizer. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for clean rooms and purification workshops.
During the production process of eye drops, filters, filtrate receiving tanks, key parts of the filling machine, etc. are required to be sterilized by high pressure steam in advance, and assembled according to aseptic operation. In addition, operators in the aseptic area wear The work clothes should also be sterilized by high pressure steam; the leakage test in the sterilization chamber of the autoclave under vacuum state, the confirmation of the steam properties, and the heat distribution and heat penetration of the sterilizer should be carried out with biological indicators. verify. Filtration sterilization is a method of removing microorganisms by adsorption or sieving through filter media. It is generally used for sterilization of heat-sensitive medicinal liquids, monitoring the microbial status of all APIs, checking bacteria before filtration sterilization, and determining contamination levels in order to formulate bioburden allowances. Scope, and then periodically verify; monitor the microbial status of production water; monitor the microbial status of containers, and investigate the microbial contamination status of newly purchased or produced containers in order to select washing and sterilization methods. Regularly test different operating points in the clean area, and the cleanliness can be confirmed by measuring the number of floating dust, planktonic bacteria, settled bacteria and adhesion; in order to maintain the sterile state of the operating clean room modular, the cleaning and disinfection methods should be formulated according to It is planned to implement cleaning and disinfection, and the verification method of cleaning effect can be the same as that of cleanliness verification; the fewer personnel entering the sterile area to perform aseptic operations, the better. Appropriate materials that do not fall off foreign objects and are easy to clean. Operators should wash their hands and disinfect their hands and wear gloves when entering the clean room, and conduct regular inspections.
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