Boben | Global Leader in Cleanroom Equipment& HEPA Filtration
Aseptic Isolators Manufacturer in China
Professional aseptic isolation systems manufacturer and supplier, safeguarding every step of the sterile process.
Leading Aseptic Isolators Manufacturer in China
As leading aseptic isolators manufacturer in china, we specialize in providing high-performance, validated aseptic isolation solutions for pharmaceutical, biopharmaceutical, medical device, and research laboratories worldwide. With over 15 years of experience in cleanroom equipment and GMP system integration, we deeply understand the critical importance of aseptic environments for drug quality and personnel safety.
Our aseptic isolators are designed to international standards, strictly complying with GMP Annex 1, ISO 14644, ISO 13408, FDA, PIC/S, and other requirements. They provide comprehensive isolation and protection for production processes, drug filling, and sampling operations, creating a truly controllable, verifiable, and traceable sterile production environment for our customers.
We not only manufacture isolation equipment but also provide comprehensive sterile control solutions. This ensures your production lines consistently meet global pharmaceutical quality and regulatory requirements.
Explore Our Aseptic Isolators
As China’s leading manufacturer of aseptic isolators, we offer a wide range of models and configurations of sterile isolation systems. Specifically designed to meet the stringent aseptic requirements of pharmaceutical, biopharmaceutical, medical device, and research laboratories.
Our Aseptic Isolators series is specifically designed to meet international standards including GMP, FDA, ISO 13408, and PIC/S, providing comprehensive isolation protection solutions for the entire process from pharmaceutical filling and sterile testing to cell therapy.
Each isolator incorporates HEPA/ULPA high-efficiency filtration systems, independent airflow and differential pressure control, and VHP automated sterilization technology. This ensures complete isolation between personnel and products while maintaining an ISO Class 5 clean environment.
Whether you perform sterility testing, cell culture, toxic drug handling, or aseptic filling and sampling, we provide validated solutions compliant with international regulations.
Our product portfolio includes:
- Aseptic Processing Isolators
- Sterility Test Isolators
- Positive & Negative Pressure Isolators
- Custom Aseptic Isolator Systems
What is an Aseptic Isolator?
Aseptic Isolator is a sealed isolation system that enables sterile operations within a completely independent isolation chamber through HEPA/ULPA high-efficiency air filtration and positive or negative pressure control. Operators perform sampling, filling, testing, or dispensing via sealed glove ports without direct contact with pharmaceuticals or the internal environment, thereby eliminating the risk of human contamination.
This system is widely applied in:
- Sterile filling and filling lines
- Aseptic compounding of raw materials
- Cell therapy and vaccine production
- Sterility testing and microbial limit testing
In short:
The Aseptic Isolator serves as the core defense in modern sterile manufacturing. It ensures product purity, personnel safety, and environmental compliance, making it the critical equipment for achieving “0 contamination” in pharmaceutical processes.
Typical Application Areas Cleanroom Aseptic Isolator
Every isolator is engineered to safeguard the safety of “product, personnel, and environment.”
Drug Filling, Raw Material Weighing, Formulation
Sterility Testing, Microbial Testing
Cell Therapy / ATMPs
Anticancer Drugs, Cytotoxic Agents
Laboratory Operations and Validation
Why Choose Us as Your Aseptic Isolators Manufacturer in China?
Choosing us as your Aseptic Isolators Manufacturer in China means you will receive a sterile isolation solution that combines safety, compliance, customization, and validation assurance.
- Extensive Experience: Over 15 years of clean equipment manufacturing expertise, with deep familiarity in international standards and applications for pharmaceutical and aseptic production.
- Rigorous Quality: Products comply with GMP, FDA, ISO 14644, EN1822, and other standards.
- Customization Support: Isolation systems tailored to client-specific process, spatial, and control requirements.
- Intelligent and Safe Design: Incorporates smart monitoring systems and user-friendly interfaces for efficient control and data traceability.
- Global Service Capability: Exported to over 30 countries, offering remote technical support, installation commissioning, and after-sales service.
Key Benefits of Using an Aseptic Isolator
✅ The Aseptic Isolator is the key equipment for achieving “zero contamination” sterile production, simultaneously balancing personnel safety, product quality, and regulatory compliance.
- Enhancing Sterile Safety: The Aseptic Isolator effectively prevents cross-contamination between personnel and products through a fully enclosed operating environment.
- Protecting Operator Safety: Operators perform tasks through glove ports, avoiding direct contact with toxic or high-risk substances to ensure personal safety.
- Ensuring Consistent Product Quality: Internal air undergoes HEPA/ULPA filtration to maintain ISO Class 5 cleanliness, guaranteeing contamination-free production of pharmaceuticals and samples.
- Compliance with GMP and International Standards: Designed to meet aseptic production regulations including GMP Annex 1, FDA, ISO 14644, and PIC/S, facilitating audit readiness and validation.
- Reduced Operational Costs and Risks: Compared to traditional cleanrooms, isolators minimize clean area footprint and personnel access frequency, lowering maintenance and energy consumption costs.
- Enhance production and testing efficiency: The equipment integrates a VHP automated sterilization system with intelligent monitoring, enabling rapid cycle sterilization and real-time data tracking.
Frequently Asked Questions about Aseptic Isolators
What is the difference between a sterile isolator and a traditional clean bench?
A: Standard HEPA filter models typically ship within 7–10 business days.
Custom products require approximately 2–3 weeks for delivery, depending on size and configuration.
With multiple automated production lines and a stable supply chain system, we can swiftly fulfill bulk orders and urgent projects.
What is the cleanliness level for the use of sterile isolators?
Answer: The air cleanliness within the internal operating area can achieve ISO Class 5 (Class 100), ensuring the entire production or testing process is conducted under controlled sterile conditions.
Does the isolator support sterilization functionality?
Answer: Yes.
The isolator can integrate an automated VHP (Vaporized Hydrogen Peroxide) sterilization system, enabling rapid sterilization, residual monitoring, and cycle validation to ensure sterile conditions are achieved before each operation.
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Why Us is Trusted by 1000+ Clients
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Professional Cleanroom System Integration Capabilities
As a specialized Cleanroom Equipment Manufacturer, we not only produce individual equipment but also possess system-level clean environment engineering capabilities.
Verifiable Product Quality and Manufacturing Reliability
Our products strictly adhere to international cleanroom standards and quality control systems throughout design and manufacturing. Each unit undergoes HEPA/ULPA efficiency testing, airflow and velocity testing, noise and energy consumption verification before shipment. We provide CNAS, SGS, or third-party certification reports for full traceability.
Global Customer Trust and Ongoing Technical Support
We serve a worldwide client base, with products exported to over 20 countries and regions including the United States, Germany, South Korea, Malaysia, the United Arab Emirates, and Singapore, earning long-term trust from international customers.