TAILIN can manufacture all the critical components in the isolator, i.e. VHPS generator, Sterility test pump,sterility test canisters;
Aseptic Isolator for sterility test, or sterile manufacturing
1. In-built VHPS generator, SAL can reach 10-6.
2. Laminar flow to create Grade A condition(in operation)
3. All air exchange pass through H14 HEPA filters
4. Pre-reserved PAO/DOP test port
5. Leakage is less than 0.5%/hour
6. VHP residue is less than 1ppm after ventilation
7. Online air sampler and particle counter for option
8. Match with TAILIN sterility test pump, to creat a perfect operation environment
9. Follow the requirement of 21CFR part 11, and GMP computerized system.
10. Complete validation documents.
11. FAT/SAT provided.