Category:
Lidding Materials
CAS NO:
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Standard:
In-house Standards,
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.