Class III isolator HTY series

for the pharmaceutical industryasepticfor sterility testing

Introduction


The HTY Series Sterility Test Isolator is a custom-designed cGMP Class A/ISO 5 isolator system, specifically engineered to provide the safest and most ergonomic working conditions for quality control operations.


Tailin hard-wall laminar flow sterility test isolator HTY series features a rigid structure made of stainless steel and tempered glass, creating a dynamic Class A internal environment.


Operations within the isolator are conducted using gloves, available in two versions: a thick, tear-resistant model and a thin, highly tactile option. The system incorporates a Siemens Programmable Logic Controller (PLC) for fully automated control of pressure and airflow volume and includes a pressure loss alarm function. Comply with GMP, USP, EP.


Features


Clean environment ensured by H14 HEPA filtration delivering Class A/ISO 5 conditions.
Integrated vaporized hydrogen peroxide sterilizers (VH2O2/VHPS) with precise H2O2 concentration and saturation control for rapid chamber decontamination.
GMP‑approved silicone inflatable seals for chamber tightness and validated containment.
Fully enclosed hard-wall barrier preventing direct operator–product contact.
Real-time monitoring of microbial settling, temperature, humidity, pressure and air velocity inside the chamber.
Automatic chamber leak testing using pressure decay method (ISO 10648-2); leakage rate <0.5% vol/hour under 2× working pressure test.
Integrated automated glove integrity testing (GIT Series) performing positive pressure decay tests (ISO 14644-7), capable of detecting holes down to 100 μm.
Data logging and management compliant with 21 CFR Part 11 for electronic records and signatures.


Optional Accessories


Half‑Suit Integrity Tester
RTP Integrity Tester
Glove Integrity Tester
Built‑in Sterility Test Pump
Air Sampler
Particle Counter
H2O2 Concentration Sensor
Barcode Printer
Barcode Scanner
Video Monitor


Applications


Designed for GMP inspections and aseptic quality control of sterile pharmaceuticals, sterile preparations and sterile APIs. Suitable for sterility testing, sampling, weighing, dispensing and related aseptic QC operations.
Note: sterility testing and aseptic processing in an isolator may be performed within a surrounding Class C/D environment in accordance with EU GMP Annex 1 and PIC/S guidance.


Technical specifications


Power supply: AC 380V / 50Hz
Max. power: 3000–4000 W
Cleanliness: GMP Class A / ISO 5
Chamber pressure range: −80 Pa to 80 Pa
Airflow direction: Laminar flow
Velocity: 0.36–0.54 m/s
Built‑in sterility test pump: 1 or multiple
Compressed air supply: 0.4–0.6 MPa (clean and dry)
Killing rate: ≥ log6
Noise: <75 dB(A) in pressure hold stage
Touch screen: 12‑inch tablet PC
Leakage rate: <0.5% vol/hour under 2× working pressure test
Vaporized H2O2 residual concentration: <1 ppm
Cabin illumination: 500 lux, LED