MIT-L20 Microbial Challenge Leak Tester

Product Introduction:

The instrument adopts positive pressure (pressurization) and negative pressure (vacuum) testing principles, suitable for microbial challenge (immersion) packaging system sealing tests of pharmaceutical packaging composite bags, blister packaging, oral solid medicine bottles, glass infusion bottles, glass injection bottles, glass ampoule bottles, oral liquid bottles, tubes, and other products.

Product Features：

Ø Integrated positive and negative pressure design principle to meet the sealing test conditions of color water method and microbial challenge method (immersion type);

Ø Industrial-grade color high-definition touch screen, clear view, menu-style interface, sensitive touch, easy to operate;

Ø "One-click" operation of the test process, high test efficiency;

Ø Automatic constant pressure air supply to ensure the test is carried out under the preset pressure conditions;

Ø Automatic anti-blow unloading function, making the test end process simple and smooth;

Ø Data such as positive pressure, negative pressure, and pressure holding time can be preset, input values, and then enter the test mode;

Ø The instrument has functions of test data storage and inquiry;

Ø Large range test range, meeting more test requirements of users;

Ø Using internationally renowned brand pneumatic components, superior sealing performance, and more reliable quality;

Ø Equipped with a mini printer, test results can be directly output and printed;

Ø Multi-level user permission management, password login, convenient for user management.

Testing Principle:

The microbial challenge sealing test, also known as the microbial immersion sealing integrity test, is usually carried out simultaneously with simulated filling. According to the simulated filling verification plan, the culture medium is simulated to fill, and then after pressing and capping, it is visually inspected to be qualified. After being sterilized in a verified sterilization cabinet, the sealing surface of the container is immersed in a high concentration of bacterial liquid, allowing the culture medium inside the sample container to fully contact the inner surface of the sealing, and the neck and outer surface of the sealing of the sample should be completely immersed in the bacterial suspension. After soaking for a certain period, it is taken out, regularly cultured, and checked for microbial intrusion to determine the integrity of the container sealing system. At the same time, a positive control test is needed to confirm the growth-promoting ability of the culture medium. The test usually uses vacuum or overpressure challenge conditions, and the MIT-L20 microbial challenge sealing test instrument can meet the related negative pressure vacuum and positive pressure overpressure test conditions.

Testing Applications:

Suitable for microbial challenge (immersion type) packaging system sealing tests of pharmaceutical packaging composite bags, blister packaging, oral solid medicine bottles, glass infusion bottles, glass injection bottles, glass ampoule bottles, oral liquid bottles, tubes, and other products.

Technical Specifications:

Product Configuration:

Standard configuration: Main unit, test tank, mini printer

Optional accessories: Non-standard test tank, non-standard test accessories, air compressor, vacuum pump

Note: The air source interface of this machine is Φ4mm polyurethane tube, and the air source is provided by the user.

Note: Jinan Zhongke Electronic Technology Co., Ltd. is always committed to the innovation and improvement of product performance and functions. Due to this reason, the product technical specifications and appearance will also change accordingly, and the above situation will not be notified separately. The company reserves the right to modify and the final interpretation.