GMP workshop preparation production control
GMP workshop preparation production control
GMP workshop water is the most widely used and most important excipient in production. In the production of injections, 70% of the quality problems are related to the quality of water. Process water must be verified, and its evaluation indicators mainly include resistivity, colony Count, bacterial endotoxin; the item of bottle washing monitoring is glass...
Text label: GMP preparation pharmaceutical cleanroom, GMP workshop design and decoration, GMP clean workshop
GMP workshop preparation production control
GMP workshop water is the most widely used and most important excipient in production. In the production of injections, 70% of the quality problems are related to the quality of water. Process water must be verified, and its evaluation indicators mainly include resistivity, colony Quantity, bacterial endotoxin; the item of bottle washing monitoring is the cleanliness of the glass infusion bottle after cleaning. It is advisable to take the cleaned infusion bottle, fill it with water for injection and shake it to obtain a water sample, and then test the insoluble particles, Indicators such as resistivity, microorganisms and endotoxins.
The preparation process includes weighing, concentrated preparation, dilution, inspection and filtration; after passing the content and PH value inspection, the fine filtration can be carried out, and the adjusted content needs to be re-measured. Enter the filling process; the inert gas in direct contact needs to be purified before use, and the amount of particles contained must meet the specified cleanliness requirements; when using the microporous filter membrane, it must be rinsed with water for injection until no foreign matter falls off, and before use Do the foaming test before and after. The filling and sealing process includes washing the bottle stopper, filling and sealing; the rubber stopper is finally rinsed with water for injection, and the rinsing water should be consistent with the water for injection; the filling volume should be checked frequently for the clarity of the semi-finished product, from dilution to the end of filling. It should not exceed 4H; adjust the pressure of the capping machine to ensure the tightness of the bottle mouth, and verify the tightness of the bottle mouth with a microbial challenge test; the sterilization conditions of the product should be based on different varieties and specifications, such as temperature, time, and placement in the sterilizer. Sterilize by quantity and arrangement level, etc.; Microbial control of semi-finished products before sterilization, and the sterility assurance value of injection after sterilization is related to the degree of microbial contamination of the product before sterilization. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP workshops and purification plants.
The semi-solid preparation matrix in the GMP pharmaceutical cleanroom should be purified and sterilized according to different types of requirements. The oily mechanism should be heated and melted, and filtered while hot to remove impurities. Visual inspection should be clear and free of foreign matter. Sterilization should be heated to 150℃ and kept for 1H Above; the water used in creams and gels should be pure water, the detection resistivity should be greater than 1m.Ω/cm, the microorganisms should be less than 100CFU/mL, and the matrix of sterile ointment must be thoroughly sterilized. Semi-finished paste should be tested for appearance, properties, PH value and content, and can be filled only after compliance with the regulations; packaging containers that are in direct contact should be cleaned and sterilized; during the filling process, the difference in monitoring filling volume should meet the regulations.
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