Sterility Test Isolator

A fully enclosed ISO 5 / Grade A isolator system designed to ensure sterility assurance and reduce contamination risk

Introduction

Model

Features

The HTY Series Sterility Test Isolator is designed to deliver reliable aseptic conditions for pharmaceutical sterility testing operations while minimizing contamination risk and operator intervention.

The system provides a fully enclosed ISO 5 / Grade A environment with integrated VH₂O₂ biodecontamination, intelligent environmental control, and 21 CFR Part 11 compliant software to support modern contamination control strategies (CCS) and regulatory compliance requirements.

The HTY Series aseptic isolator is designed to ensure compliance with EU GMP Annex 1, FDA cGMP, USP and EP requirements while delivering high sterility assurance, consistent aseptic process performance, and improved testing reliability for critical pharmaceutical applications.

Engineered for QC laboratories, biologics, and advanced therapy environments, it enhances process reproducibility and audit readiness across regulated sterility testing workflows.

Hard-wall laminar flow aseptic isolator features a rigid structure made of stainless steel and tempered glass

Fully automated control of pressure and airflow volume, includes a pressure loss alarm function

High-performance, customizable modular isolators, available in custom sizes

Model

HTY-1650AG3

HTY-1800G4

HTY-1800G8

Features

Sterile Assurance：

HTY series isolators provide a controlled ISO 5 / Grade A sterile environment for sterility testing applications.
H14 HEPA filtration ensures consistent high air quality within the isolator chamber.
Integrated vaporized hydrogen peroxide (VHP) sterilization with precise concentration control enables rapid and reliable internal decontamination, ensuring a validated sterile environment for testing operations.
Inflatable GMP-grade silicone seals ensure chamber tightness and system integrity.
A fully enclosed physical barrier eliminates direct operator-to-product contact, significantly reducing contamination risk.
Real-time monitoring of particles, temperature, humidity, pressure, and airflow ensures continuous environmental control.

Integrity Testing & Containment Assurance:

Automatic leak testing based on ISO 10648-2 verifies chamber integrity using the pressure decay method, ensuring leakage rates below 0.5% volume per hour under twice working pressure.
Integrated glove integrity testing system (GIT Series) performs automated testing for each glove according to ISO 14644-7 standards, detecting defects as small as 100 μm.

Data Integrity & Compliance:

The system supports 21 CFR Part 11 compliance requirements, including electronic records and electronic signature functionality for regulated pharmaceutical environments.
Audit trail and data management functions ensure traceability of critical process parameters and support regulatory inspection readiness.

Specifications

Power Supply: AC380V/50Hz	Max.Power: 3000W-4000W
Cleanliness: GMP Class A	Chamber Pressure Range: From -80Pa to +80Pa
Airflow Direction: Laminar flow	Velocity: 0.36~0.54m/s
Built-in Sterility Test Pump: 1 or multiple	Compressed Air Supply: 0.4MPa-0.6MPa clean and dry
Killing Rate: ≥log6	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 Illuminating: 500 lux, LED light source

Compliance

Regulatory Standards：

The HTY Series Sterility Test Isolator is designed in accordance with EU GMP Annex 1 requirements for aseptic processing and contamination control strategy (CCS).

The system design is aligned with ISO 14644 cleanroom classification principles and ISO 10648-2 isolator containment standards.

It is suitable for use in USP <71> sterility testing workflows when operated within a validated laboratory process.

Data Integrity：

Optional software functionality can support 21 CFR Part 11 requirements, including electronic records and audit trails.

Validation Support：

Validation support include IQ, OQ, PQ, FAT, SAT, and VH₂O₂ cycle qualification activities.

Applications

For GMP inspections of sterile pharmaceuticals, including sterile preparations and sterile active pharmaceutical ingredients.

For sterility tests, sampling, weighing, dispensing, etc.

Note: The sterility test, aseptic preparation and ﬁlling could be conducted in an isolator located whithin Class C/D, according to EU GMP Annex 1 and PIC/S<Recommendation on Sterility Testing> 8.1.1