HTY-SZ1806B Soft Chamber Sterility Test Isolator

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HTY-SZ1806B Soft Chamber Sterility Test Isolator

Product ID：SHGCglq021

Price: Please inquire PDF Format

Supply Ability:50SETS/MON

Port:SHENZHEN

Product Introduction
Other information

Model NumberHTY-SZ1806B

Brand NameZJTAILIN

Payment TermsTT，PAYPAL，Alibaba.com Pay

HTY-SZ1806B Soft Chamber Sterility Test Isolator
Product Introduction
HTY-SZ1806B Soft Chamber Sterility Test Isolator is an advanced aseptic isolation system designed for sterility testing of sterile pharmaceutical products and active pharmaceutical ingredients (API). It provides a controlled Grade A clean environment for pharmaceutical QC laboratories and research laboratories, supporting both membrane filtration and direct inoculation sterility testing methods required by pharmacopoeia standards.
Developed by Hangzhou Tailin Bioengineering Equipment Co., Ltd., the system integrates soft chamber isolation technology, HEPA filtration, positive pressure control, automated PLC operation, and hydrogen peroxide vapor sterilization interfaces to ensure reliable contamination control and operator protection during sterile testing procedures.
The HTY-SZ1806B isolator is widely used in pharmaceutical microbiological testing, sterile drug quality control, vaccine testing, biotechnology research, and API sterility analysis.

Product Features
• Soft Chamber Isolation Structure
The isolator adopts a transparent PVC soft chamber design with a fully enclosed top structure. The integrated control unit, air supply/exhaust system, and filtration components provide an elegant appearance, easy cleaning, and convenient maintenance.
• Supports Two Pharmacopoeia Sterility Testing Methods
The system is compatible with both membrane filtration and direct inoculation methods. The collection pump unit can be integrated directly into the operation platform to simplify testing procedures.
• Flexible Modular Configuration
The operation chamber and transfer chamber can be combined for complete aseptic transfer operations or used independently according to laboratory requirements.
• High-Efficiency Air Filtration and Positive Pressure Protection
Both inlet and outlet air ports are equipped with H14 grade HEPA filters and high-performance centrifugal fans imported from Germany. The turbulent airflow mode continuously maintains positive pressure inside the chamber.
• Hydrogen Peroxide Vapor Sterilization Compatibility
The system provides reserved ports and valves for connection with VHPS® hydrogen peroxide sterilization equipment. Hydrogen peroxide vapor sterilization can achieve a log6 sporicidal effectiveness on exposed surfaces and internal air.
• Reliable Sterile Material Transfer System
The isolator can connect with sterilizable transfer bags, RTP (Rapid Transfer Port) systems, and other transfer devices to realize safe and aseptic material transfer.
• Automatic PLC Control System
Equipped with Siemens PLC control modules and a color touchscreen interface, the system enables automatic operation, real-time monitoring, and pressure loss alarms.
• Multi-Functional Interface Design
The system provides multiple connection interfaces, including 25 mm standard sanitary quick connectors, utility interfaces (electricity and gas), and validation/testing ports.
• FDA 21 CFR Part 11 Compliant Data Management
Multi-level user management, electronic data recording, and export functions are available. The software design meets FDA 21 CFR Part 11 requirements for electronic records.

Working Principle
The HTY-SZ1806B Soft Chamber Sterility Test Isolator creates a controlled aseptic environment by continuously supplying filtered air through H14 HEPA filtration units. The internal positive pressure prevents external contaminants from entering the chamber during sterility testing operations.
During operation, samples are transferred through the sterile transfer system into the isolator. Operators perform sterility tests using membrane filtration or direct inoculation methods inside the Grade A clean environment.
After testing, the chamber can be sterilized through hydrogen peroxide vapor technology to eliminate microorganisms and maintain a high-level aseptic condition for subsequent operations.

Technical Parameters

Parameter	Specification
Model	HTY-SZ1806B
Product Type	Soft Chamber Sterility Test Isolator
Power Supply	AC 220V / 50Hz
Power Consumption	1500W
Touch Screen	Siemens 7-inch color touchscreen
Internal Pressure Control Range	0-80Pa
Humidity Resolution	0.1%
Temperature Resolution	0.1℃
Pressure Resolution	0.1Pa
Internal Cleanliness Level	Static Grade A
Leakage Rate	≤0.5% per hour
Material Door Diameter	500mm
Transfer Door Diameter	280mm
Exhaust Pipe Diameter	50mm
Air Filtration	H14 HEPA filter
Control System	Siemens PLC automatic control

Application Areas
HTY-SZ1806B Soft Chamber Sterility Test Isolator is mainly applied in sterile pharmaceutical quality control and laboratory testing environments.
Typical applications include:
• Sterility testing of sterile injections and pharmaceutical preparations
• Sterility testing of sterile APIs (Active Pharmaceutical Ingredients)
• Pharmaceutical microbiological quality control laboratories
• Vaccine and biotechnology product testing
• GMP pharmaceutical research and development laboratories
• Aseptic sample preparation and contamination-controlled testing

Advantages Compared with Traditional Sterility Testing Environments

Comparison Item	Traditional Clean Bench / Open Testing Area	HTY-SZ1806B Sterility Test Isolator
Contamination Control	Depends on operator environment and operation skills	Fully enclosed isolation environment
Cleanliness Level	Limited protection capability	Static Grade A clean environment
Sterility Assurance	Higher contamination risk	Continuous positive pressure protection
Operator Safety	Limited isolation protection	Physical isolation between operator and sample
Sterilization Method	Manual cleaning required	Compatible with hydrogen peroxide vapor sterilization
Data Management	Limited recording capability	Electronic records and user management

Why Choose HTY-SZ1806B Soft Chamber Sterility Test Isolator?
• Provides a reliable Grade A aseptic testing environment for pharmaceutical QC laboratories
• Supports official pharmacopoeia sterility testing methods including membrane filtration and direct inoculation
• Reduces contamination risks during sterile product testing
• Combines automatic control, HEPA filtration, and sterilization capability in one integrated system
• Suitable for GMP-compliant pharmaceutical and biotechnology applications

Frequently Asked Questions (FAQ)
1. What is the HTY-SZ1806B Soft Chamber Sterility Test Isolator used for?
The HTY-SZ1806B is designed for sterility testing of sterile pharmaceutical products and APIs, providing an isolated Grade A clean environment for microbiological testing procedures.
2. Which sterility testing methods does this isolator support?
The system supports both membrane filtration and direct inoculation methods required by pharmacopoeia sterility testing standards.
3. Does the HTY-SZ1806B meet GMP requirements?
Yes. The system adopts pharmaceutical-grade isolation technology, electronic data management, and FDA 21 CFR Part 11 compliant software design, making it suitable for GMP laboratory applications.
4. How does the isolator maintain an aseptic environment?
The isolator uses H14 HEPA filtration, continuous positive pressure control, and optional hydrogen peroxide vapor sterilization to maintain a clean and controlled environment.
5. Can the transfer chamber be customized or connected with other systems?
Yes. The system supports connection with sterilizable transfer bags, RTP systems, and other aseptic transfer solutions.
6. What are the key purchasing considerations for a sterility test isolator?
Users should consider clean level requirements, supported testing methods, sterilization compatibility, pressure control accuracy, data compliance, and after-sales technical support. HTY-SZ1806B provides a complete solution for pharmaceutical sterility testing applications.

Conclusion
HTY-SZ1806B Soft Chamber Sterility Test Isolator is a professional pharmaceutical aseptic testing isolation system designed to improve sterility assurance, reduce contamination risks, and support regulatory-compliant microbiological testing. With Grade A clean protection, automatic control, HEPA filtration, and hydrogen peroxide sterilization compatibility, it is an ideal solution for pharmaceutical QC laboratories, API manufacturers, and biotechnology research facilities.

Frequently Asked Questions (FAQ)
1. What is the HTY-SZ1806B Soft Chamber Sterility Test Isolator used for?
The HTY-SZ1806B is designed for sterility testing of sterile pharmaceutical products and APIs, providing an isolated Grade A clean environment for microbiological testing procedures.
2. Which sterility testing methods does this isolator support?
The system supports both membrane filtration and direct inoculation methods required by pharmacopoeia sterility testing standards.
3. Does the HTY-SZ1806B meet GMP requirements?
Yes. The system adopts pharmaceutical-grade isolation technology, electronic data management, and FDA 21 CFR Part 11 compliant software design, making it suitable for GMP laboratory applications.
4. How does the isolator maintain an aseptic environment?
The isolator uses H14 HEPA filtration, continuous positive pressure control, and optional hydrogen peroxide vapor sterilization to maintain a clean and controlled environment.
5. Can the transfer chamber be customized or connected with other systems?
Yes. The system supports connection with sterilizable transfer bags, RTP systems, and other aseptic transfer solutions.
6. What are the key purchasing considerations for a sterility test isolator?
Users should consider clean level requirements, supported testing methods, sterilization compatibility, pressure control accuracy, data compliance, and after-sales technical support. HTY-SZ1806B provides a complete solution for pharmaceutical sterility testing applications.