Aseptic penicillin bottles are the most common form of drug packaging material in clinical medicine. If a leak occurs in a sterile penicillin bottle, the drug will definitely be affected.
What are the reasons for the sealing leakage of sterile penicillin bottles? Firstly, it is possible that there are issues with the body of the penicillin bottle itself, such as cracks, bubbles, and micropores in the glass bottle during processing and transportation. Secondly, it is possible that the leakage is caused by a problem with the rubber stopper itself, which is rare but also exists in actual production.
The integrity tester for penicillin bottles adopts the vacuum decay method to create an internal and external pressure difference in the sample immersed in vacuum chamber water, observe the gas leakage inside the sample, and determine the sealing performance of the sample; It is also possible to determine the sealing performance of the sample by evacuating the vacuum chamber to create an internal and external pressure difference, observing the shape recovery of the sample after expansion and release of vacuum, and the liquid infiltration.
The detection process of penicillin bottle integrity tester:
1. Place the penicillin bottle sample to be tested in water in the vacuum chamber of the penicillin bottle sealing integrity tester;
2. Apply a layer of water to the sealing ring around the sealing tester, close the sealing cover to prevent air leakage during the testing process;
3. Set test parameters such as vacuum degree and vacuum holding time, lightly press the test button to start the test;
4. During the vacuuming or pressure holding process of the equipment, carefully observe whether there are continuous bubbles around the cap of the penicillin bottle. If there are continuous bubbles, immediately press the stop button lightly to stop the vacuuming of the equipment and display the pressure value at which the sample leaked. If there are no continuous bubbles in the sample and no water has infiltrated, it indicates that the sample has good sealing performance;
5. In order to comply with the requirements of the new version of GMP for the integrity of testing record data of drug packaging materials testing instruments, the instruments have specially set up data audit tracking and hierarchical permission management functions.
With the continuous development of the pharmaceutical industry, pharmaceutical companies hope to quickly launch their products while saving production and operating costs. How to produce penicillin bottle products with multiple dosage forms and specifications more economically and quickly has become a new issue.