GMP workshop requirements for sterilization?
GMP workshop requirements for sterilization?
Before any sterilization process in the GMP pharmaceutical cleanroom is put into use, physical testing methods and biological indicators must be used to verify its applicability to the product or article and the sterilization effect of all parts; the effectiveness of the sterilization process should be regularly checked Re-verification of the performance of the equipment, after major changes in the equipment, must be...
Text label: GMP pharmaceutical cleanroom design, GMP workshop installation and purification, sterilization requirements
GMP pharmaceutical cleanroom requirements for sterilization?
Before any sterilization process in the GMP workshop is put into use, physical testing methods and biological indicators must be used to verify its applicability to the product or article and the sterilization effect of all parts; the effectiveness of the sterilization process should be regularly checked Re-validation should be carried out after major equipment changes, and re-validation records should be kept; the loading method of products and items to be sterilized in the sterilization equipment chamber should be confirmed through validation; during validation and production process, it is used for monitoring Or the temperature probe for recording and the temperature probe used for control should be set separately, and the setting position should be determined through verification, and the time-temperature curve of the sterilization process should be recorded for each sterilization; if the automatic control and monitoring system is used, it should be verified , to ensure that the requirements of key processes are met, the automatic control and monitoring system should be able to record the system and the failures during the operation of the process, and be monitored by the operator; there should be measures to prevent the sterilized products or items from being contaminated during the cooling process.
The parameters of moist heat sterilization process monitoring should include sterilization time, temperature or pressure. In a sterilization cabinet equipped with a drain at the bottom of the chamber, the temperature data at this point during the whole sterilization process should be measured and recorded if necessary. If the sterilization process includes vacuuming, the chamber should be regularly tested for leaks; except for the sealed products, the sterilized items should be properly wrapped with suitable materials, and the materials and wrapping methods should be conducive to air discharge, Steam penetrates and prevents contamination after sterilization. All parts of the sterilized item should be fully contacted with the sterilization medium within the specified temperature and time. During dry heat sterilization, the sterilizer chamber should circulate and maintain positive pressure during the start-up period to prevent non-sterile air from entering. The air entering the chamber should be filtered by a high-efficiency filter, and the high-efficiency filter should be tested for integrity. The lower limit of the sterilization temperature range is the sterilization temperature, the upper limit should not exceed the sterilization temperature + 3°C, and the difference between the points at the same time in the sterilization stage should not exceed 2°C; and 134 ℃ sterilizer, the maintenance time should not be less than 15min, 10min and 3min respectively. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP workshops and sterile workshops.
For the exposure balance stage of the moist heat sterilizer, the temperature in the chamber should not exceed 1.5℃ of the average temperature; the temperature difference between the temperature control probe, recorder and the nearby temperature probe of the steam sterilizer should not exceed 1.0℃; all For thermocouples, the difference at the same time is not more than 2°C; the controller sterilization time shown in the sterilization cabinet printout has an error of no more than 1% in the predetermined exposure stage; the pressure shown in the sterilization cabinet printout is the same temperature The error of the pressure displayed by the standard saturated steam table is not more than 1.6%. For liquid loading sterilization, a small amount of gas is often left at the top of the liquid container. When the liquid is heated, the gas at the top expands, and the pressure in the container increases. The temperature inside the container is higher than that outside the container during the cooling phase, and the pressure inside the container increases. It will also be higher than the pressure in the chamber; in order to maintain the shape and sealing integrity of the container, air pressurization is required to increase the pressure of the chamber and reduce the pressure difference between the chamber and the container; the air entering the chamber must be removed first. The bacteria filter is used for filtration. In order to prevent the temperature fluctuation in the chamber caused by adding cold air, the air should be preheated before entering the chamber. Common air pressurization procedures include steam-air mixing sterilization procedures and superheated water sterilization procedures. .
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