Liquid preparation in purification workshop
Liquid preparation in purification workshop
All raw and auxiliary materials, inner packaging materials and other materials should enter the pharmaceutical cleanroom according to: article → unpacking (outer cleaning, disinfection) → enter the pharmaceutical cleanroom according to the process of entering the clean area; The material name, batch number, quantity, character, specification of the intermediate product or packaging material...
Text label: purification workshop engineering, purification workshop design, Zhongjing global purification
Liquid preparation in purification pharmaceutical cleanroom
All raw and auxiliary materials, inner packaging materials and other materials should enter the workshop according to: article → unpacking (outer cleaning, disinfection) → enter the workshop according to the process of entering the clean area; The material name, batch number, quantity, character, specification, type, etc. of intermediate products or packaging materials shall be reviewed; the weighing range and verification validity period of measuring instruments shall be reviewed before each process is produced. Before batching, check the name, batch number, manufacturer, specification and quantity of the raw and auxiliary materials, all of which should be consistent with the inspection report. The operator in the batching position will bring the raw and auxiliary materials into the batching room according to the requirements of the production task, and the batching room must be checked and cleared by the QA personnel. , the preparation conditions should meet the requirements of production conditions; before weighing, all personnel should check and weigh the materials according to the amount of the master formula; the remaining raw and auxiliary materials should be sealed and stored, and the product name, batch number, date, remaining amount, etc. should be marked outside the container; After the operation is completed, the equipment and utensils shall be cleaned, disinfected and dried according to the corresponding operating procedures, the workplace shall be cleaned, and the site clearance record shall be kept.
According to the requirements of the production task, the raw and auxiliary materials are sent to the dosing room through the transfer window, and stored in the raw and auxiliary materials storage room; check the shift record to understand the operation of the equipment and the variety and output produced on the day, open the oven, and control the drying temperature When the temperature is above 150°C, clean the bottle washer and the indoor environment according to the 'Cleaning Operation Regulations for Bottle Washing MachinesIf the situation occurs, press the stop button and take it out with tweezers; when the bottle is washed, close the water valve and the compressed air valve in turn, press the stop button, clean the equipment and fill in the batch production records carefully and in time; after the oral liquid bottle is cleaned and dried From the exit of the conveyor belt, the bottle receiving personnel pick out the broken bottles and the water bottles, and then put the qualified oral liquid bottles into the aluminum frame with a scraper, put the transfer order, and place them in the designated position of the bottle receiving room; Or the dried bottle should be used up within 24H. If it is not used up after 24H, it should be returned to the washing bottle for re-washing. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for purification workshops and purification projects.
The sterilization personnel strictly abide by the sterilization temperature and time according to the operating procedures, carefully check whether the received quantity is consistent with the encapsulation transfer quantity, place the products neatly after sterilization, fill in the transfer form for semi-finished products, and place them in the designated storage area; After each batch of production, the site shall be cleared according to the 'Clearance Operation Regulations'. Understand the production varieties, specifications, batch numbers and quantities of the day. There are clearance certificates and production licenses in the operation room, and the status of pending inspection is marked. Close the door with the light-proof paper to ensure that the room is dark and quiet. The empty baskets and tools used, and the status signs are hung up; the lamp inspection personnel operate according to the workshop 'Operation Regulations for Lamp Inspection PostsAfter inspection, the products are neatly placed, fill in the delivery form, and put them in the designated storage area.
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