In the realm of biological research and pharmaceutical production, maintaining a sterile and safe environment is crucial. The OEB4 / OEB5 Isolator, developed and produced by Shanghai QUALIA, stands out as a cutting-edge solution that combines advanced technology with stringent safety standards.
Advanced Features of the OEB4 / OEB5 Isolator
Modular Design and Compliance
The OEB4 / OEB5 Isolator boasts a modular design that is fully compliant with Good Manufacturing Practice (GMP) standards. This design allows for easy customization to fit different volumes, shapes, and heights, making it adaptable for both fixed and mobile vessels.
Filtration and Sterilization Systems
The isolator features two types of filtration systems: the barrel-style PUSH-PUSH and the centralized BIBO (Bag-In Bag-Out) system, both paired with laminar flow. This ensures a sterile work environment throughout the manufacturing process. Additionally, the isolator includes Vaporized Hydrogen Peroxide (VHP) sterilization capabilities, providing a reliable and efficient method for maintaining sterility.
Integrated Preparation and Cleaning Systems
The OEB4 / OEB5 Isolator comes equipped with an integrated Preparation/CIP (Clean-in-Place) and SIP (Sterilization-in-Place) system. This setup is ideal for liquid compounding or the safe formulation of powders, ensuring all processes are carried out in a sterile and controlled environment.
Rapid Transfer and Customization
The isolator utilizes Rapid Transfer Port (RTP) connections, allowing for the accommodation of a variety of vessels. This feature enhances efficiency and reduces the risk of contamination during material transfer. Full customization options are available, enabling users to tailor the isolator to their specific needs.
Ensuring Biosafety
Unidirectional Airflow and HEPA Filters
The OEB4 / OEB5 Isolator features unidirectional airflow and a dual exhaust HEPA filter system, minimizing the risk of accidental exposure during filter replacement. This ensures a sterile work area throughout the manufacturing process, maintaining ISO Class 5 air cleanliness.
Automatic Protection Systems
In case of special risks or emergency faults, such as door seal or glove damage, the isolator's automatic protection system activates to maintain inward airflow and prevent contamination. This includes real-time monitoring of the inner chamber’s air tightness with alarm systems.
Applications and Benefits
The OEB4 / OEB5 Isolator is engineered for a wide range of applications, including:
- Sterile Production: Ensures a sterile environment for the production of pharmaceuticals and biological products.
- Aseptic Experimentation: Ideal for aseptic experiments and biological research.
- Biosafety in Biological Experiments: Provides a safe environment for handling biosafety level 3 and 4 materials.
- Handling Allergenic/Toxic Substances: Safely handles substances that are allergenic or toxic.
- Maintenance of SPF Laboratory Animals: Ensures the maintenance of Specific Pathogen Free (SPF) grade laboratory animals.
Compliance and Verification
The OEB4 / OEB5 Isolator meets international cGMP standards and conducts Class 3 pressure tests as per ISO 10648-2. It maintains ISO 14644-1 air cleanliness at an ISO 5 level and complies with USP <797> and <800> standards. Professional verification documentation and services are provided with all validation process control achievable at every node.
Key Features Summary
| Feature | Description |
|---|---|
| Modular Design | Compliant with GMP standards, customizable for different volumes, shapes, and heights |
| Filtration Systems | Barrel-style PUSH-PUSH and centralized BIBO (Bag-In Bag-Out) with laminar flow |
| Sterilization | Vaporized Hydrogen Peroxide (VHP) sterilization capabilities |
| Integrated Preparation/CIP & SIP | Ideal for liquid compounding or safe powder formulation |
| Rapid Transfer Ports | Utilizes RTP connections for accommodating various vessels |
| Unidirectional Airflow | Maintains ISO Class 5 air cleanliness |
| Automatic Protection Systems | Activates in case of special risks or emergency faults to maintain inward airflow |
| Compliance | Meets international cGMP standards, ISO 10648-2, ISO 14644-1, USP <797>, and <800> |
The OEB4 / OEB5 Isolator by QUALIA is more than just a piece of equipment; it's a comprehensive solution for ensuring sterility, safety, and compliance in various biological and pharmaceutical applications. With its advanced filtration systems, modular design, and integrated cleaning and sterilization capabilities, this isolator sets a new standard in the industry. Whether you're involved in sterile production, aseptic experimentation, or the handling of sensitive substances, the OEB4 / OEB5 Isolator is your trusted partner in maintaining a safe and sterile environment.
