In the realm of biological research and pharmaceutical manufacturing, maintaining a sterile and safe environment is crucial. The QUALIA Biosafety Isolator, developed and manufactured by Shanghai QUALIA, stands out as a cutting-edge solution designed to protect both the operator and the product from potential biological hazards.
What is the QUALIA Biosafety Isolator?
The QUALIA Biosafety Isolator is a proprietary enclosed isolation system engineered for Occupational Exposure Band (OEB) production protection, sterile production, aseptic experiments, biological experiments requiring stringent biosafety measures, and the breeding of Specific Pathogen Free (SPF) level laboratory animals.
Key Features of the QUALIA Biosafety Isolator
Sterility and Safety
- ISO Class 5 Airflow: The isolator maintains unidirectional total exhaust airflow, ensuring a sterile workspace throughout the manufacturing process.
- Dual Exhaust HEPA Filter: Equipped with a Bag-In Bag-Out (BIBO) system, this filter minimizes accidental exposure during replacement, achieving >99.999% efficiency at 0.1 to 0.3 micrometers.
- Real-Time Monitoring: The isolator includes alarm systems to monitor the inner chamber’s air tightness, safeguarding against unexpected exposure risks.
- Automatic Protection: In case of emergencies like door seal or glove damage, an automatic protection system activates to maintain inward airflow.
Customization and Compliance
- High Containment Level: The isolator passes pressure decay tests with no leakage below +750pa, ensuring a secure environment.
- Stainless Steel Structure: The full-welded stainless steel construction ensures durability and meets international cGMP standards.
- Adaptive Exhaust Systems: These systems can be configured to meet specific user needs, including options for in-situ decontamination and scanning devices.
Innovation and Integration
- Standalone Control Modules: These modules simplify electrical maintenance and offer the option to use Siemens industrial computers or touch screens.
- Plug-and-Play Capabilities: The SCI Class III isolated units are ideal for clients without access to 100% duct systems, achieving pressures up to -250Pa.
- Modular Design: Large isolators can be assembled on-site, avoiding transportation issues.
Design and Verification
- Built-in VHP Generators: Optional VHP generators ensure operational safety and sterilization reliability, sharing a control system with the isolators for single-point validation and maintenance.
- Professional Verification Documentation: Comprehensive verification services are provided, ensuring validation at every node.
Compliance with Standards
The QUALIA Biosafety Isolator adheres to stringent international standards:
- cGMP Compliance: Meets current Good Manufacturing Practice standards.
- ISO 10648-2: Passes Class 3 pressure tests.
- ISO 14644-1: Maintains ISO 5 air cleanliness.
- USP <797> and <800>: Complies with United States Pharmacopeia standards for pharmacy compounding and hazardous drugs handling.
Types of Isolators
| Isolators | Type |
|---|---|
| Aseptic Isolator / Sterility Test Isolator (Positive Pressure) | ORBS (Open Type), CRBS (Closed Type) |
| Biosafety Isolator (Negative Pressure) | P3/P4 Biosafety Protective Isolator (Closed Type) |
| OEB Protective Isolator | (Closed Type) |
Advanced Filtration and Sealing
- HEPA Filters: Comply with IEST-RP-CC001.3 and EN 1822 standards, ensuring high-efficiency particulate air filtration.
- FDA Grade EPDM Static Seals: Enhance the system’s durability and contamination control.
Operational Flexibility
- Interchangeable Pressure Configurations: The workspace and airlock transfer area can be configured for either positive or negative pressure operation, tailored for sterile non-hazardous materials or containing sterile hazardous substances.
In conclusion, the QUALIA Biosafety Isolator is a robust and innovative solution for any laboratory or manufacturing facility requiring high levels of biosafety and sterility. With its advanced features, customizable options, and strict adherence to international standards, this isolator ensures a safe and sterile environment, protecting both your work and your well-being.
