Design and installation of aseptic workshop for freeze-dried powder injection
Design and installation of aseptic workshop for freeze-dried powder injection
The aseptic pharmaceutical cleanroom process of freeze-dried powder injection first cleans the freeze-drying box, and then performs leak rate detection after sterilization, that is, the integrity detection of the bellows of the corrugated plug and the mushroom valve, and then the leakage rate of the system is detected. , which proves that the system has a good vacuum, and the product can be put into the box; if...
Text label: Freeze-dried powder injection sterile workshop, sterile pharmaceutical cleanroom design and installation
Design and installation of aseptic pharmaceutical cleanroom for freeze-dried powder injection
The aseptic workshop process of freeze-dried powder injection first cleans the freeze-drying box, and then performs leak rate detection after sterilization, that is, the integrity detection of the bellows of the corrugated plug and the mushroom valve, and then the leakage rate of the system is detected. , to prove that the system has a good vacuum before the product can be put into the box; if the freeze dryer does not have a cleaning-in-place and sterilization-in-place system, it needs to be cleaned manually and sterilized by other suitable methods. The entire freeze-drying cycle is divided into charging, Pre-freezing, evacuation, drying, pre-deflation, pressure rise, pressure plug, deflation, storage, discharge, etc. In the automatic operation mode, the freeze-drying cycle is automatically performed according to the above steps; after the product is dried, vacuum is performed as required Pressing plug or nitrogen-filled pressurizing plug, if vacuum pressurizing, immediately after drying; Press the plug. After the plug is completed, the air is released to atmospheric pressure and the box is released, and the follow-up operation is continued after the box is released.
The vial washing machine and the tunnel sterilization dryer are inline production. The bottle feeding area of u200bu200bthe washing machine can be installed in the D-class clean area. The outlet of the tunnel sterilization dryer is connected to the front turntable of the filling machine. It is a Class A clean area; the filling area is the core area for the production of freeze-dried products, and is generally designed as a local Class A environment under the background of Class B. The whole process of the filling machine transfer is under the protection of Class A laminar flow; The preparation process of bacteria-packed products is relatively simple. The sterile raw materials or the mixture of sterile raw materials and auxiliary materials are sub-packed into vials, corked, capped, labelled, boxed, boxed, etc., sterile powder The sub-packaging exposes the product, filling is usually carried out in the A-level one-way flow area, and the time interval between sub-packaging and corking should be minimized; because the corked vial is considered incomplete before the cap is rolled. Therefore, the capping area is generally a local A-level environment under the C-level background. The vials should always be in A-level laminar flow protection before capping. A large amount of aluminum scraps will be generated during the aluminum capping process, and appropriate traps need to be installed. dust device to avoid the influence of aluminum chips. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for sterile workshops and sterile workshops.
Since the freeze dryer needs to be in a vacuum state for a long time during production, the higher the vacuum leakage level of the freeze dryer, the better the sterility assurance level of the product, and the general vacuum leakage rate will be better than 0.02Pa. m3/s, the time from normal pressure to 10Pa should be less than 30min, and the ultimate vacuum can reach below 1Pa; for freeze dryers with automatic feeding and discharging devices, the flatness of the board should reach the level of 0.5mm/m, and the positioning accuracy of the board It should be within ±0.5mm to ensure the smooth connection between the board layer and the automatic feeding and discharging system; the temperature control accuracy of the board layer of the freeze dryer should reach ±1°C, and the temperature distribution within the board layer and the temperature difference between the board layers should also reach ±1 At the level of ℃, the temperature of the freeze dryer plate layer should be cooled from 20℃ to -40℃, the cooling time should be less than 30min, and the limit temperature of the back box should be lower than -70℃.
The filling area of u200bu200bthe sterile workshop needs to monitor the dynamic monitoring items such as the pressure difference, wind speed, dust particle count, planktonic bacteria, settled bacteria and so on in the A-level environment from time to time. The filling pump of the filling machine can be a plunger pump or a peristaltic pump. , the filling accuracy is generally better than 1%; the leakage rate and wind speed of the high-efficiency filtration in the preheating section, sterilization section and cooling section of the sterilization tunnel need to be monitored regularly. The sterilization tunnel can control the internal pressure of the tunnel by adjusting the operating frequency of the exhaust fan. The difference is to maintain a relative positive pressure externally. The pressure difference before and after the high-efficiency filter of each section of the sterilization tunnel is an important indicator for evaluating filter clogging.
, need to be observed and recorded at any time.
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