Validation of sterile preparation process in dust-free workshop
Validation of sterile preparation process in dust-free pharmaceutical cleanroom
The production process of sterile preparations in dust-free workshops is usually divided into terminal sterilization process and non-terminal sterilization process. Terminal sterilization process products include large-volume injections and small-volume injections, and aseptic process products include aseptic filling liquids Formulations, sterile subpackaged powders and lyophilized powders...
Text label: clean room construction, clean room design, sterile preparation process verification
Aseptic preparation process validation in dust-free workshop
The production process of sterile preparations in dust-free workshops is usually divided into terminal sterilization process and non-terminal sterilization process. Terminal sterilization process products include large-volume injections and small-volume injections, and aseptic process products include aseptic filling liquids Preparations, sterile subpackaged powder injections and freeze-dried powder injections, etc.; packaging materials that directly contact drugs, such as rubber stopper containers, usually have four types of contamination: microorganisms, endotoxins, external particles and external chemical pollution. The contamination is controlled within the specified range, and it should be used after sterilization if necessary. The cleaning and sterilization processes of the materials must be verified; for the aseptic process, the utensils and equipment parts that directly contact the inner packaging materials and products must be cleaned and sterilized. bacteria.
The corresponding cleanliness level of the preparation should be determined according to the characteristics of the sterile preparation product, and the prepared liquid should be tested, such as content, pH, etc.; sterilization filtration can reduce the microbial load of the liquid before filling , The compatibility of the filter for filtering the liquid with the liquid should be confirmed under the worst conditions, the integrity of the filter after filtration should be checked, and if necessary, the integrity of the filter before filtration should also be checked. Liquid filling is generally carried out by means of metering piston pump or time-pressure control system; the filling of aseptic products is a key process step in the production of aseptic drugs, and the filling area is the core of the entire clean environment; filling or The time that the sub-box is sealed should be shortened to minimize the possibility of contamination, and measures must be taken to reduce the interference of workers in critical areas, such as door-to-door shutdown alarm functions in critical areas, and even isolation technology to isolate operator intervention, some The product is protected by nitrogen filling after filling. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for dust-free workshops and sterile workshops.
The full sealing operation of aseptic freeze-dried products in the dust-free pharmaceutical cleanroom is that after the products that are fully plugged in the freeze dryer are taken out of the box, they are sent to the capping machine to complete the capping operation; the products that are not capped are not fully sealed The transfer of the products must be carried out under the protection of Class A cleanliness. In the capping area, an appropriate cleanliness level should be designed in combination with the sealing performance of the product, equipment conditions, and characteristics of the aluminum cap; the capping process is prone to metal particles or rubber plugs falling off. Therefore, consideration should be given to setting up the necessary decontamination facilities and inspection devices to eliminate contamination and ensure the sealing integrity of the product.
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