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What is a Closed Restricted Access Barrier System (cRABS)?
The Closed Restricted Access Barrier System (cRABS) designed by Shanghai QUALIA is a state-of-the-art aseptic processing solution. It creates a highly controlled, enclosed environment to protect the production of sterile or minimally toxic products. This system maintains a positive pressure regime, using advanced air filtration systems to ensure high levels of air cleanliness, in accordance with ISO Class 5 air quality standards.
Key Features of QUALIA's cRABS
Air Filtration
- HEPA filters ensure the maintenance of ISO Class 5 air purity.
- Expertly engineered airflow prevents contamination and maintains a pristine environment within the system.
Physical Barrier
- A solid barrier prevents direct operator-product contact, safeguarding product sterility.
Controlled Environment
- Critical environmental parameters such as temperature, humidity, and pressure are meticulously managed to suit sensitive pharmaceutical handling.
Design Versatility
- Systems are inherently versatile, designed to adapt to various production needs and facility configurations.
- Features include integrated glove ports, state-of-the-art LED illumination, and comprehensive control systems for precise monitoring and automation.
Types of cRABS
Passive cRABS
- Utilize the facility’s existing HVAC airflow, leveraging centrally supplied HEPA-filtered air to maintain a clean atmosphere.
Active cRABS
- Feature an autonomous air handling unit, enabling complete environmental control.
- May include advanced options for automated decontamination and specialized material transfer systems.
Additional Benefits and Features
Enhanced Sterility
- cRABS provide superior sterility compared to open front clean air devices, such as laminar flow clean benches and Class II biological safety cabinets.
Cost Efficiency
- Reduce operating and renovation costs by taking up less space than traditional cleanroom facilities.
Advanced Control Systems
- Sentinel™ Gold Microprocessor controller supervises all functions and monitors airflow and pressures in real-time.
Robust Construction
- Dual-wall construction with negative pressure plenums at the sides and back ensures robust environmental control.
Comparison Table: Key Features of QUALIA's cRABS
| Feature | Description |
|---|---|
| Air Filtration | HEPA filters ensuring ISO Class 5 air purity |
| Physical Barrier | Solid barrier preventing direct operator-product contact |
| Controlled Environment | Meticulous management of temperature, humidity, and pressure |
| Design Versatility | Versatile design with integrated glove ports and LED illumination |
| Passive cRABS | Utilizes existing HVAC airflow with centrally supplied HEPA-filtered air |
| Active cRABS | Autonomous air handling unit with options for automated decontamination |
| Sterility | Superior sterility compared to open front clean air devices |
| Cost Efficiency | Reduces operating and renovation costs by taking up less space |
| Control Systems | Sentinel™ Gold Microprocessor controller for real-time monitoring |
| Construction | Robust dual-wall construction with negative pressure plenums |
Conclusion
QUALIA's Closed Restricted Access Barrier System (cRABS) is a cutting-edge solution for aseptic processing, offering a highly controlled environment that ensures the sterility and safety of pharmaceutical products. With its advanced air filtration, physical barriers, and versatile design, cRABS is an essential tool for any facility involved in the production of sterile or minimally toxic products. Whether you opt for passive or active cRABS, this system promises to deliver superior sterility and efficiency, making it a valuable investment for your pharmaceutical operations.
