Glucose injection is a large-dose injection injected into the body by intravenous drip. It mainly supplement the necessary nutrients, calories and water, maintain the balance of water and salt in the body, improve blood circulation, prevent and treat shock, adjust acid-base balance, dilute and excrete toxins, etc.
Glucose Injection Process: Container Treatment - Liquid Preparation - Filtration - Filling and Sealing - Sterilization - Quality Inspection and Packaging.
1. Container Treatment
Treatment of infusion bottle: Generally use 3% concentration of sodium carbonate solution at 70℃ to rinse through the bottle washing machine for 10 seconds, then rinse the alkaline solution with pure water, and finally rinse with injection water. Treatment of rubber stopper: first wash with deionized water, boil for 30 minutes with 0.5% strength sodium hydroxide solution, rinse lye with deionized water, rinse with injection water, then boil for 30-60 minutes with 1% strength hydrochloric acid, rinse acid with deionized water, finally rinse with injection water. Isolation film generally uses polyester and polypropylene film. Treatment of polyester film: after soaking in 95% ethanol, boil with injection water or autoclave at 115℃ for 30 minutes, then rinse with injection water. Treatment of polypropylene film: soak in 10% hydrochloric acid for 12 hours, rinse with injection water after taking out. Treatment of plastic infusion bags: first wash the surface with clean water, then pour in injection water and close the mouth of bag; autoclaving for 30 minutes for standby use. When it’s ready for use, discharge the injection water in the bag and then rinse with injection water for 3 times.
2. Liquid Preparation
First of all, ensure that the quality of the raw materials for the glucose injection meet health standard, then weigh the required raw materials and injection water to prepare a concentrated solution. After boiling, adsorbing by activated carbon, filtering, use injection water to dilute to the required concentration.
In the case of mass production, sand filter rods are generally used for primary filtration of the glucose injection stock solution, then use vertical fusion filter to do more precisely filtration for the solution. Finally after filtering through HONGTEK microporous membrane pleated filter cartridges, it could move on next step for filling and sealing. Following are some HONGTEK microporous membrane pleated cartridges for your reference:
By the way, HONGTEK could provide the filter element needed in the injection water filtration process. Primary filtration: NPP Series Melt Blown Cartridge, APP Series Melt Blown Cartridge. Precise filtration: PCF Series Pleated Filter, APC Series Pleated Filter, GFM Series Pleated Filter.
4. Filling and Sealing
The filling and sealing part is a key area for the production of glucose injection, and its environment must meet clean requirement. The filtered glucose injection should be poured into the treated infusion bottle immediately to avoid contamination of the injection. Then covered by isolation film and plugged by rubber stopper, both of them are rinsed with injection water before using. Finally seal the bottle mouth with an aluminum cap.
The encapsulated glucose injection should be sterilized immediately, generally using autoclave sterilization at 100℃ for 30 minutes. If the volume of the infusion solution is large, the sterilization time could be extended to 45 minutes. Noted: different batches of glucose injection could not be sterilized together
6. Quality Inspection and Packaging
After sterilization, the glucose injection is tested for temperature, bacteria, heat source, clarity, etc. Clarify testing generally uses artificial light inspection: put the product under a fluorescent lamp and observe the clarify in the bottle with eyes, label the injection which is passing the test according to the requirement, and then package it.