Product Introduction
The JM-MIT01 Microbial Intrusion Sealing Tester is suitable for microbial intrusion sealing tests and is widely used for sealing tests of various materials such as vials, ampoules, infusion bags, pre-filled needles, and aseptic packaging bags for eye drops.
Test Principle:
The microbial intrusion test, also known as the microbial challenge test, is a common method for testing the integrity of a seal, usually conducted simultaneously with a simulated filling process. The process involves simulating the filling of the culture medium according to a simulated filling validation protocol, followed by capping and visual inspection. After sterilization in a validated sterilizer, the sealed surface of the container is immersed in a high-concentration bacterial suspension, ensuring that the culture medium inside the sample container fully contacts the inner surface of the seal. The neck and outer surface of the seal should be completely submerged in the bacterial suspension. After a certain period of immersion, the container is removed, and periodic incubation is performed to check for microbial intrusion, thus determining the integrity of the container's sealing system. A positive control test is also required to confirm the growth-promoting ability of the culture medium. The test typically utilizes vacuum or overpressure challenge conditions.
Product Features:
1. 7-inch touchscreen control, integrated positive and negative pressure testing machine;
2. Automatic testing, automatic zero-point calibration upon startup, supports manual sensor calibration, and automatic shutdown upon completion of the test;
3. Different types of sample racks (10ml vials/10ml ampoules/500ml infusion bags, etc.) can be configured for various test items (customization available);
4. Equipped with a 30-liter stainless steel tank with casters at the bottom to meet the testing needs of more test materials; the tank also has a drainage trough.
5. The measurement system has high accuracy, good linearity, and fast response. The sensor over-range protection ensures smooth operation and high accuracy of the motion drive system.
6. The product adopts a three-level access control system; test data is automatically saved, historical records can be queried, data cannot be changed, and can be audited and traced;
7. Mini printer for printing test statistics at any time;
8. It is equipped with a standard serial communication interface; dedicated computer communication software is provided, which can perform real-time display of experiments, data analysis and processing, and data storage; it can perform single and group statistical analysis of experimental results;
