MODEL: HTY Series
FEATURES:
Sterile Assurance
HTY series isolators ensure the highest air quality within the isolation environment:
– Engineering filtration system comprising H14 High-Efficiency Particulate Air (HEPA) filters
– The integration of the latest generation of vaporized hydrogen peroxide sterilizers developed by Talin, coupled with precise hydrogen
peroxide gas concentration/saturation control technology, which rapidly steriizes the 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
HTY series isolator is 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
HTY series isolators are 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.
SPECIFICATION
| Model | Description | Overall Dimensions | Operating Space | Operating Space |
| HTY-1250G2 | Operating chamber with
Pass box-2 Gloves |
2300 × 870 × 2420 mm | 1240 × 680 × 700 mm | 600 × 550 × 700 mm |
| HTY-1650G3 | Operating chamber with
Pass box-3 Gloves |
2700 × 870 × 2420 mm | 1640 × 680 × 700 mm | 600 × 550 × 700 mm |
| HTY-1800G4 | Operating chamber with
Pass box-4 Gloves |
2850 × 870 × 2420 mm | 1790 × 680 × 700 mm | 600 × 550 × 700 mm |
| HTY-1800G8 | Operating chamber with Pass box-8 Gloves (Double Side) | 2650 × 1240 × 2420 mm | 1750 × 1200 × 650 mm | 600 × 650 × 600 mm |
| HTY-1250AG2 | Operating chamber- 2 Gloves | 1675 × 870 × 2420 mm | 1250 × 680 × 700 mm | – |
| HTY-1650AG3 | Operating chamber- 3 Gloves | 2075 × 870 × 2420 mm | 1640 × 680 × 700 mm | – |
| HTY-1800AG4 | Operating chamber- 4 Gloves | 2225 × 870 × 2420 mm | 1790 × 680 × 700 mm | – |
| HTY-1800AG8 | Operating chamber-8 Gloves (Double Side) | 2370 × 1240 × 2420 mm | 1750 × 1200 × 650 mm | – |
| Power Supply: AC380V/50Hz | Max.Power: 3000W-4000W |
| Cleanliness: GMP Class A | Airflow Direction: Laminar flow |
| Chamber Pressure Range: From -80Pa to +80Pa | Velocity: 0.36~0.54 m/s |
| Built-in Sterility Test Pump: 1 or multiple | Bio-decontamination Capacity: ≥106-log |
| Compressed Air Supply: 0.4MPa-0.6MPa clean and dry | Noise: ＜75dB(A) when in pressure hold stage |
| Touch Screen: 12″ Tablet PC | Leakage Rate: ＜ 0.5% /vol/hour under 2 times working pressure test |
| Vaporized Hydrogen Peroxide Residual Concentration: ＜1ppm | Cabin Illumination: 500 lux, LED light source |
