In the pharmaceutical industry, maintaining a sterile environment during testing, sampling, weighing, and dispensing operations is critical for ensuring product quality and patient safety. As regulatory requirements continue to evolve, manufacturers are increasingly adopting advanced Sterility Test Isolator and Aseptic Isolator technologies to minimize contamination risks while improving operational efficiency.
The HTY Series Sterility Test Isolator, developed by Tailin, is a custom-designed cGMP Class A / ISO 5 isolator system engineered specifically for pharmaceutical quality control applications. Designed with operator safety, process reliability, and regulatory compliance in mind, it provides a fully enclosed aseptic environment that supports sterility testing and other critical operations while reducing the risk of microbial contamination.
Tailin: An Integrated Life Science Solution Provider
Founded in 2002, Zhejiang Tailin Bioengineering has grown into a comprehensive solutions provider serving biotechnology, pharmaceutical engineering, precision medicine, radiopharmaceuticals, food safety, and advanced materials industries. The company employs nearly 1,000 professionals, including approximately 200 R&D engineers, and has obtained more than 300 national patents. Its products are used by pharmaceutical manufacturers, laboratories, hospitals, cleanrooms, and research institutions in over 50 countries.
Among its portfolio of life science solutions, the HTY Series Aseptic Isolator stands out as a highly specialized platform for sterility assurance and contamination control.
What Is a Sterility Test Isolator?
A Sterility Test Isolator is a fully enclosed barrier system designed to create and maintain a controlled aseptic environment for sterility testing and related pharmaceutical processes. Unlike traditional cleanroom-based operations, isolators physically separate operators from products through glove ports and sealed chambers, significantly reducing the possibility of contamination.
The HTY Series features a rigid hard-wall construction made from stainless steel and tempered glass. The internal workspace maintains a dynamic GMP Class A / ISO 5 environment, while operators perform tasks using either highly durable tear-resistant gloves or thinner gloves designed for enhanced tactile sensitivity. The system is controlled by a Siemens PLC that automatically manages pressure and airflow while providing pressure-loss alarms for additional operational security.
Advanced Sterility Assurance Technology
H14 HEPA Filtration for ISO 5 Protection
The foundation of any effective Aseptic Isolator is its air filtration system. The HTY Series utilizes H14 High-Efficiency Particulate Air (HEPA) filtration to maintain ISO 5/Class A cleanliness conditions throughout the chamber. This ensures exceptionally high air quality and helps prevent airborne contamination during critical testing procedures.
Integrated Vaporized Hydrogen Peroxide Bio-Decontamination
The system incorporates Tailin’s latest-generation Vaporized Hydrogen Peroxide (VHP) sterilization technology. Precise control of hydrogen peroxide concentration and saturation enables rapid and effective bio-decontamination of the chamber interior before operations begin.
The VHP system achieves a sterilization efficacy of at least 6-log microbial reduction, providing a highly reliable sterile environment for sterility testing applications. Residual hydrogen peroxide concentration remains below 1 ppm after aeration, supporting both safety and operational readiness.
Fully Enclosed Physical Barrier
A critical advantage of the HTY Series Sterility Test Isolator is its completely enclosed design. Operators never come into direct contact with products or test samples, dramatically reducing the likelihood of contamination caused by human intervention. GMP-approved inflatable silicone seals further ensure chamber integrity and containment.
Automatic Leak Testing for Chamber Integrity
Maintaining containment integrity is essential for any isolator system. The HTY Series includes an automated chamber leak testing function based on the pressure decay method specified in ISO 10648-2.
Each chamber undergoes independent testing to verify system tightness. The measured leakage rate is maintained at less than 0.5% volume per hour under a test pressure equal to twice the working pressure, demonstrating excellent containment performance and regulatory compliance.
This automated verification process helps laboratories ensure consistent performance while simplifying validation and qualification activities.
Automated Glove Integrity Testing
Gloves are among the most critical components of an isolator barrier system. Even minor damage can compromise sterility and product protection.
To address this risk, the HTY Series incorporates an integrated automated Glove Integrity Testing (GIT) system. Following the positive pressure decay methodology described in ISO 14644-7, each glove can be independently tested for leaks.
The system is capable of detecting defects as small as 100 μm in diameter, allowing operators to identify potential failures before they impact product quality.
Real-Time Environmental Monitoring
Modern pharmaceutical manufacturing requires continuous monitoring of critical environmental parameters. The HTY Series provides real-time supervision of:
- Settling microorganisms
- Temperature
- Relative humidity
- Chamber pressure
- Airflow velocity
This continuous monitoring strategy helps ensure that environmental conditions remain within validated operating limits throughout testing and production activities.
Data Integrity and Regulatory Compliance
Regulatory agencies increasingly emphasize electronic records, traceability, and data integrity. The HTY Series Aseptic Isolator supports these requirements through compliance with 21 CFR Part 11, including electronic records and electronic signature functionality. Audit trails and data management tools provide comprehensive documentation for inspections and validation activities.
The system is designed to comply with major international pharmaceutical standards, including:
- GMP
- USP
- EP
- EU GMP Annex 1
- ISO 10648-2
- ISO 14644-7
- 21 CFR Part 11
These capabilities help pharmaceutical manufacturers maintain regulatory readiness while simplifying compliance management.
Applications of the HTY Series Sterility Test Isolator
The HTY Series is suitable for a broad range of pharmaceutical quality control and aseptic processing activities, including:
- Sterility testing
- Sampling operations
- Weighing procedures
- Dispensing activities
- Aseptic preparation
- Aseptic filling
- Quality control testing of sterile products
- Inspection of sterile active pharmaceutical ingredients (APIs)
According to EU GMP Annex 1 and PIC/S recommendations, sterility testing and aseptic processing can be conducted within an isolator installed in a surrounding Class C or Class D environment, reducing cleanroom requirements while maintaining high sterility assurance levels.
Technical Specifications
The HTY Series Sterility Test Isolator offers robust technical performance:
| Parameter | Specification |
| Cleanliness Level | GMP Class A / ISO 5 |
| Chamber Pressure Range | -80 Pa to +80 Pa |
| Airflow Type | Laminar Flow |
| Air Velocity | 0.36–0.54 m/s |
| Power Supply | AC 380V / 50Hz |
| Maximum Power | 3000–4000 W |
| Compressed Air Supply | 0.4–0.6 MPa (clean and dry) |
| Leakage Rate | <0.5% vol/hour under 2× working pressure |
| VHP Residual Concentration | <1 ppm |
All system dimensions can be customized to accommodate specific laboratory layouts and operational requirements.
As pharmaceutical manufacturing moves toward increasingly stringent contamination control strategies, the adoption of advanced Sterility Test Isolator and Aseptic Isolator technologies has become essential. The HTY Series combines ISO 5/Class A environmental control, automated VHP bio-decontamination, chamber leak testing, glove integrity testing, real-time environmental monitoring, and 21 CFR Part 11-compliant data management within a single integrated platform. By delivering exceptional sterility assurance, reliable containment performance, and comprehensive regulatory compliance, the HTY Series helps pharmaceutical laboratories improve testing reliability, protect product quality, and meet the demanding requirements of modern aseptic operations.
For more information, please visit Tailin’s website or contact Tailin directly at +86-571-8658-9087 or marketing@tailingood.com. You may also follow Tailin on Facebook, YouTube, LinkedIn and Instagram to stay updated on the latest products, technologies, and industry insights.
Read Our One More Blog: Tailin Containment Isolator Solutions for High-Potency Material Handling
