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Zhejiang Tailin Biotechnology Co., Ltd
TECHLEAD® BIT-L01 Bacterial Invasion Tester
NegotiableUpdate on 05/06
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Overview
TECHLEAD #174; BIT-L01 Bacterial Invasion Tester is a specialized instrument used for testing the integrity of sterile drug packaging. By setting different pressure change scenarios, it verifies the barrier performance of specific packaging containers and sealing processes against microorganisms. Conducting sealing tests on sterile drug packaging such as penicillin bottles, ampoules, pre filled needles, and eye drops bottles through microbial invasion, to assist pharmaceutical companies in evaluating injection consistency.
Product Details
application field
l Injection consistency evaluation, packaging integrity testing
l Verification of capping and sealing process
l Validity verification of physical inspection methods
l Research on the correspondence between physical aperture and microbial penetration
l Drug stability research and validation
l Challenge testing of sterile packaging transportation and storage conditions
Product Features
1. Customized infiltration stent design to ensure sufficient contact between the sample and bacterial solution;
2. Equipped with automatic and manual testing programs, reducing operation time and providing a smoother operating experience;
3. It can store multiple formula programs to meet the testing needs of different packaging products;
4. Vacuum positive pressure switching program, more challenging and consistent testing conditions;
5. The experimental data is automatically saved, historical records can be queried, data cannot be changed, and can be audited and tracked;
6. High temperature resistant transparent sealed tank, no need to remove for cultivation, meeting biosafety requirements;
7. Vacuum pumping, bacterial liquid injection, pressurization, bacterial liquid discharge, cleaning, and transfer cultivation are all completed under fully enclosed conditions;
8. The host and test tank are designed in a separate manner, with quick connection of pipes for safe and leak free operation;
9. The product complies with GMP user level three permissions;
10. Micro needle printer, capable of printing the test results of each batch;
11. Equipped with a standard USB data export interface;
12. Data report generation, storage, and query functions.
Product features
l Automatic testing function:After setting the formula parameters, the system automatically completes the testing;
l Reminder function:Display reminders for the steps of the detection process flow;
l Real time printing function:Real time printing function for basic testing information and testing process data;
l Parameters can be set:The detection parameters such as pressure and holding time can be set;
l Recipe editing call:Support Chinese input, with recipe editing and calling function, avoiding repeated input and easily completing detection;
l Equipment self-test function:Ensure the airtightness of the pipelines inside the testing tank and the main engine;
l Self cleaning function:Capable of self-cleaning the tank body;
l Permission management:Third level permission management.
Meets professional standards
l Compliant with USP43 1207.2 Packaging Integrity Testing Technical Requirements;
l Complies with the NMPA CDE Technical Guidelines for Sealing Research of Chemical Injection Packaging Systems;
l Meets GAMP5 validation requirements;
l Compliant with biosafety protection requirements.
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