Sterile Assurance: HTY series isolators ensure the highest air quality within the isolation environment:

• Engineering filtrationsystem comprising H14 HEPA filters.
• The integration of the latest generation of vaporized hydrogen peroxide sterilizers developed by Tailin, coupled with precise hydrogen peroxide gas concentration/saturation control technology, which rapidly sterilizesthe internal environment of the chamber, guaranteeing a sterile environment during sampling processes.
• Inflatable seals made of GMP-approved silicone ensure the tightness of the chamber.
• A fully enclosed physical barrier avoids direct contact between operators and products, addressing the issue of microbial contamination.
• Real-time monitoring of settling microorganisms, temperature, humidity, pressure, and airspeed within the chamber ensures the production environment remains continuously controlled.

Automatic Leak Testing: Equipped with an automatic leak testing system that individually tests each chamber for leaks using the pressure decay method as described in international standard ISO 10648-2. Leakage rate is less than 0.5% /vol/hour under 2 times working pressure test.

Glove Integrity Testing: Equipped with an integrated automated glove leak testing system (GIT Series) which performs an independent leak test on each glove installed on the isolator system according to the positive pressure decay method described in the international standard ISO 14644-7. It detects holes as small as 100μm in diameter.

Data Management: Comply with 21 CFR Part 11 electronic records and signature requirements.