Vitamin C injection potting should pay attention to: gas purity and pressure
Potting is an important part of the production process of small volume injections. Because vitamin C is extremely unstable, in the potting process of the injection, it is necessary to strictly control the factors such as the purity and pressure of the potting gas to achieve the purpose of improving product quality and finished product yield. Multi-Pass Cock Valve,Cock Valve,Pressure Cock Valve Zhejiang Hisern Medical Technology Co., Ltd , https://www.hisernmedical.com
Vitamin C is an acidic polyhydroxy compound containing 6 carbon atoms. Its chemical name is L(+)-threose-2.
3,4,5,6-pentahydroxy-2-hexenoic acid-4-lactone, also known as ascorbic acid. a specific enol structure in its molecule,
It is easily oxidized and the oxidation process is complicated. Under aerobic conditions, it is first oxidized to form dehydroascorbic acid, and then hydrolyzed to form 2,3 diketo-L-gulonic acid without therapeutic activity, and 2,3 diketone-L-gulonic acid can be Further, oxalic acid and L-butyric acid are produced.
In the production process of vitamin C injection, the oxygen content of the gas in the void above the surface of the ampoule has a greater influence on the stability of the injection. The inert gas should be filled during the potting process. In order to ensure the quality of the aeration, the current two-needle aeration method is used in the production, namely ventilation-potting-ventilation-melting. (Recommended to use our factory's glass perfusion device resistant to strong acid and alkali corrosion. Please visit our booth or:)
â– Strictly control the inflation pressure In order to control the pressure of the potting gas, it is first necessary to install three pressure gauges on the nitrogen flow path: install a pressure display on the gas outlet of the cylinder to visually see the pressure of the cylinder; The pressure display is placed in front of the linkage to indicate the pressure before entering the linkage; the third is mounted on the flow meter on the linkage so that the Zui finally controls the air pressure entering the needle.
The pressure of the six needle couplings is preferably 0.4 to 0.6 MPa on the flow meter. During the potting process, it is better to see the liquid in the bottle being blown up by nitrogen gas, and the liquid does not overflow or produce a coke head. The residual oxygen in the liquid bottle is also qualified, so that the qualified rate of the finished product can reach 95%. ~100%. If the pressure is too large (greater than 0.6
MPa), the liquid is easily blown out, polluting the machine, causing unnecessary waste, and the dosage is not accurate;
The liquid is blown to the mouth of the bottle and is easy to produce a coke head. The liquid splashes on the wall of the ampoule and is likely to form a carbonization point when the bottle is sealed and sealed. The burning liquid falls into the bottle, which may cause the unsatisfactory degree of clarity and affect the product. Quality and filling yield lead to high reject rates. If the air pressure is too small (less than 0.4 MPa), the air inside the bottle will be exhausted (available CY-2)
The type of oxygen meter is used for the determination of residual oxygen. The liquid medicine in the liquid medicine bottle is difficult to be blown up in the small pit, but it is only slightly wrinkled. The amount of residual oxygen will affect the quality of the vitamin C injection. The product in the finished disc will be discolored. Some products will not be discolored even after sterilization, and the shelf life will be greatly shortened.
â– Maintaining gas purity In order to ensure the purity of nitrogen gas, four 10,000 liters of stoppered glass bottles containing 5,000-6,000 ml of absorbing liquid (gallic acid, potassium permanganate, water) and air can be used. Purify and stabilize the pressure to prevent the pressure from being large and small, which makes the potting process difficult to master and affects the filling quality. Also, remove the absorbent from the bottle and clean the glass bottle before leaving work every day. The absorption liquid must be changed once a day to ensure the purification of nitrogen by the absorption liquid.