Divon Pharma manufactures in full accordance with GMP regulations. In order to ensure that the environment inside the workshop is not polluted, the staff must replace the special work shoes and overalls before entering the GMP workshop, and then go to the production area after washing, disinfecting and drying. According to the GMP requirements of veterinary drug, when entering the clean production area of water needle, oral liquid and tablet, the staff will carry out two or three more, and replace the special clean clothes. The clean clothes are divided according to different cleanliness levels and production areas. Different colors prevent cross-contamination.
The production of water needles and oral liquids requires different levels of process water, and the water production room is the place where process water is prepared. The drinking water is coarsely filtered by a mechanical filter and an activated carbon filter, and purified water is prepared through a first-stage reverse osmosis device and a second-stage reverse osmosis device, and the purified water is then sterilized by ultraviolet light, and a multi-effect distilled water machine is used to prepare water for the workshop. The purified water and the workshop water prepared meet the needs of different production processes in the workshop.
Injectable Solution Production Line
After injection bottles being removed the outer packaging in outer unpacking room; those bottles were cleaned with ultrasonic bottle washing machine in a 100,000-class clean area, rinsed twice and blown the clean compressed air once, then rinsed with fresh injection water once and blown clean compressed air three times. Then delivered to the tunnel-type sterilization dryer, dry and sterilize at 300 °C; the rubber plugs are transferred to the rubber plug cleaning room according to the regulations, and then put into the rubber plug cleaning machine, purified water for rough washing, injection water for fine washing. When inspection is qualified, initiate prescribed sterilization procedure, and the sterilized bottles and plugs are transported to the filling workshop of the 10,000-class clean area for filling, nitrogen filling and plugging. Then delivered to the 100,000-level clean area and carry out the rolling. Then perform leak detection and sterilization. The products are delivered to the light inspection room for light inspection. After the light inspection is passed, the products are delivered to the packaging room for labeling and packaging.
All injection products should conduct sterility test in the microbiological laboratory before storage. The sterile room has strict cleaning and disinfection procedures. The cleanliness level is 10,000 classes. The clean level of the clean bench is 100 classes. Each door has a pressure gauge to display the pressure difference. The indoor air pressure is higher than the external air pressure to prevent bacteria from passing through the air to enter the sterile room.
Oral Solution Production Line
The oral solution production area has a clean level of 100,000 grades. It uses an eight-pump linear liquid filling and capping machine, which can produce up to 3,000 bottles per hour. The oral solution is outsourced by an automatic cartooning machine, 6000 bottles per hour.
Tablet/Bolus Production Line
the raw materials of the tablets are sieved through the storage chamber into the screening room, and then into the mixing chamber to mix the dry powder evenly. The starch slurry is prepared in the mixing chamber, the dry powder of the tablet is added to the trough mixer, the prepared starch slurry is added to the trough mixer to be stirred into a soft material, and the particles are granulated by the rocking granular machine, and then placed in a hot air circulation oven after granulation. Dry in the middle. After the whole grain, add the three-dimensional mixer to the total mixing. After passing the test, it is pressed into a tablet by a tableting machine.
Powder/Granule Production Line
Powder and granules already crushed and weighed out are sent to the mixing workshop with different turnover drums. After mixing, the test is passed, being sent to the transit workshop. Then transferred to the inside bag workshop through different pipes in transit workshop. After the turnover drum is done, those will be sent to the area to be cleaned according to GMP requirements, and then sent to the cleaned area after cleaning. The pipeline feeding method from the third floor to the second floor reduces the turnover links from batching to dispensing, improves work efficiency, and reduces dust pollution. The mixed medicines are conducted sub package inside bag workshop and packed in the outer compartment. The sub-assembly workshops all use fully automatic filling machines. Reduced manual operations, avoided human pollution, and improved product quality.
According to GMP production requirements, all tools used in the clean room are autoclaved, sterilized by a pressure steam sterilizer, and placed in the appliance storage room for reuse.
After the finished products are completed, the finished product will be delivered to the finished product warehouse to be inspected through the logistics channel. The quality assurance department will inspect the product and make detailed records to ensure the quality of the product and provide the best quality products to the customer. After the quality assurance department passes the inspection, the finished products will be delivered to the qualified area from the area to be inspected. Each batch of finished products shall be sampled according to the regulations, and the finished products shall be inspected regularly to trace the product quality. The information fed back by the customer may be judged by re-examination of the sample.
24-hour monitoring is carried out on the factory area and various production workshops. The general manager of the company via local area network can check the situation of the factory area and various production links at any time. The production director supervises and directs the production of each workshop through monitoring.