The World'S Top 500 Partners
The World'S Top 500 Partners
From sterility testing to aseptic production, Toone Biotechnology safeguards the safety of every dose with hardcore technology.
In the field of aseptic pharmaceuticals, microbial contamination is the Sword of Damocles hanging overhead. With the increasingly stringent requirements of EU-GMP Annex 1 and the Chinese Pharmacopoeia for Contamination Control Strategies (CCS), traditional cleanrooms can no longer meet the demands of high-risk operations. What you need is not just a sealed enclosure, but an aseptic solution integrating physical isolation, dynamic environmental control, and intelligent data traceability.
WenZhou Toone Biotechnology Equipment Co., Ltd., rooted on the coast of the East China Sea, has focused on sterile isolation technology for over a decade. We provide customized aseptic assurance systems for the pharmaceutical, biotechnology, and laboratory sectors.
1. Dual-Chamber Design, Flexible Adaptation to Complex Processes
Soft/Hard Chamber Options: Choose between transparent PVC soft chambers for panoramic observation and quick installation, or stainless steel hard chambers for robustness, durability, and pressure stability.
Combined Application: The operating chamber and transfer chamber can be used together or operated independently. Supports seamless integration with RTP systems and steam sterilization bags for sterile transfer of items, completely cutting off cross-contamination pathways.
2. Ultimate Sterile Environmental Control
ISO Class 5 (Class 100 / Grade A) Cleanliness: The chamber utilizes H14 grade HEPA filters (double filtration for supply/exhaust) paired with high-performance centrifugal fans imported from Germany, ensuring a static Grade A or dynamic Class 10,000 clean environment.
Comprehensive VHP Sterilization: Integrated vaporized hydrogen peroxide (VHP) sterilization system achieves a 6-log sporicidal effect on chamber surfaces and air. Post-sterilization residue concentration is below 1ppm, ensuring the safety of operators and materials.
3. Precise Physical Barrier and Human-Machine Interaction
High Airtightness: The chamber body uses seamless welding technology, achieving an hourly leak rate of ≤0.5% (positive pressure test), stricter than industry standards.
Ergonomic Operation: Integrated long-arm glove ports, with options for puncture-resistant heavy-duty gloves or thin high-sensitivity gloves, enhancing operational dexterity while ensuring absolute isolation.
4. Intelligent Brain: Fully Automated Control System
Siemens PLC Core: Utilizes Siemens logic controllers and touch-screen color displays for fully automated operation, real-time monitoring of differential pressure (adjustable from -90Pa to +90Pa), temperature, humidity, and airflow velocity.
Data Traceability: Compliant with GMP computer system validation requirements, supporting multi-point login permission control and audit trails. All environmental parameters are automatically stored for hassle-free validation.
Pressure Control: Accuracy 0.1Pa, wide adjustment range -90Pa~90Pa, positive pressure protection, negative pressure containment.
Airflow Pattern: Vertical unidirectional laminar flow, airflow velocity 0.36~0.54m/s, eddy-free design.
Sterilization Method: VHP/UV/Combination sterilization (depending on model).
At Toone, the isolator is not just equipment; it is an extension of your drug quality system. Choose Toone, choose a compliant, safe, and efficient aseptic future.