Freeze-dried preparation filling in purification workshop
Freeze-dried preparation filling in purification workshop
The purification pharmaceutical cleanroom calculates the central filling volume according to the active ingredient prescription of the solution. The filling volume should meet the semi-finished product filling volume standard. After filling, the semi-finished product should be semi-topped and lined up. The whole process should be in 100-level one-way laminar flow under protection; trays filled with bottles are placed on trolleys or automatically fed...
Text label: purification workshop design and installation, purification workshop filling, purification workshop engineering
Purification workshop freeze-dried preparation filling
The purification workshop calculates the central filling volume according to the active ingredient prescription of the solution. The filling volume should meet the semi-finished product filling volume standard. After filling, the semi-finished product should be semi-topped and lined up. The whole process should be in 100-level one-way laminar flow Carry out under protection; place the tray filled with bottles on a trolley or an automatic feeding device, place the semi-finished vials on the shelf rack in the freeze-drying warehouse under the protection of a one-way flow hood, install the temperature-measuring vials in the warehouse, and close them for drying. The freeze-drying control room is opened, and the freeze-drying control room is notified. The operator of the freeze-drying control room confirms that the eutectic point and temperature control vial temperature measuring probe in the drying box is under control, and the freeze-drying operation can be started; Freeze-drying program curve, freeze and dry in a drying box, automatically record shelf temperature, product temperature, heating medium temperature, vacuum condenser temperature and vacuum degree, and finally do a vacuum differential pressure test in the drying box to judge the freeze-drying of the product Whether the process is over; when the freeze-drying process is all over, the sterile room operator cooperates with the freeze-drying control room operator to fill the drying box with sterile N2 or sterile compressed air, and wait until the vacuum in the drying box returns to normal pressure After the state is finished, use the hydraulic cylinder or mechanical lifting device to squeeze the shelf in the drying box, and plug the bottle with a rubber stopper; after the whole stopper is completed, take out the vial from the warehouse and send it to the capping room for capping. Check the clarity, and use a capping machine for capping after passing the test. During the capping process, 10 bottles should be taken out every 30 minutes to check the strength of the capping, and the capped vials should be sent out through the conveyor belt.
In the transfer process of aseptically filled semi-pressed products in the freeze-drying process, in order to prevent contamination, the semi-pressed products can only be transported in the key area, and it should be ensured that there is sufficient space between the filling line and the freeze dryer. Class 100 unidirectional clean air flow, the same protective measures are required for shipping operations; semi-finished products after filling in a sterile environment, i.e. semi-pressed glass containers with rubber stoppers on metal trays, or solutions in open trays, usually It is transferred to the drying chamber of the freeze dryer; in the process of transferring the vial to the freeze dryer, there is still a risk of contamination because it has not been sealed. Completed under protection, usually the filling line is installed near the door of the lyophilizer drying box, and an isolation facility is installed from the filling line to the lyophilizer. A mobile laminar flow vehicle can also be used as a remedy. This process is best Automatic loading devices can be used to increase the degree of sterility assurance of the product. Proper isolation in the operation area is a necessary measure to prevent contamination. After filling, the transfer of semi-finished products and the lyophilization loading are under the protection of 100-level unidirectional clean air flow, and the surrounding area is 10000-level. Cleanliness, there should be proper airflow from the high-level area to the adjacent lower-level area; in order to ensure sterile conditions, the high-efficiency air filter should be kept intact, generally speaking, the high-efficiency filter in the sterile operating room, every year At least two integrity checks should be performed. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for purification workshops and sterile workshops.
The design of the sterile process should aim to minimize the exposure of sterile items at the risk of contamination in production operations. In order to achieve a high level of sterility assurance, reduce the exposure time of sterile items, and control the environment as strictly as possible , optimizing the process flow, and preventing low-quality air from entering the 100-level area in the design is critical. In areas where semi-finished products are moved, the flow of people and logistics should be optimized to prevent the risk of contamination of product exposure, containers and closures or the surrounding environment from unnecessary activities. The goal is to reduce the number of people entering and exiting the sterile field and the most important critical areas. The filling process should be carried out under the condition of 100-level dynamic cleanliness, and the surrounding environment of filling should be at least 10,000-level cleanliness. If conditions permit, it is safer to increase the cleanliness of the environment to 100-level static conditions. ; After filling, the inner container of the inner package should be closed, the ampoules can be heated and sealed, and the vials and pre-filled syringes should be sealed with rubber stoppers; freeze-dried products should use special freeze-dried rubber stoppers to facilitate the freeze-drying process. In the sublimation drying and desorption drying stages, the harmful fillers in the rubber stopper will not escape under low pressure, contaminating the product, resulting in unqualified clarity of the product; The cleaned and sterilized rubber stopper is fed into the rubber stopper feeding track through a vibrator, and the vibrator can accurately adjust the position of the rubber stopper on the bottle mouth to maintain the gap between the half stopper and the bottle mouth, so as to maintain the sublimation during the freeze-drying process. When drying, the water vapor channel and the process of adding the rubber stopper are under the protection of 100-level unidirectional clean air flow to prevent the rubber stopper from being polluted by the environment.
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