In the intricate and demanding world of biological research and pharmaceutical manufacturing, maintaining a sterile and safe environment is not just a necessity, but a lifeline. This is where the QUALIA Biosafety Isolator steps in, a cutting-edge solution that redefines the standards of biosafety and sterility. Let’s dive into what makes this innovative system a game-changer.

A Sterile Fortress: Key Features of the QUALIA Biosafety Isolator

Developed and manufactured by Shanghai QUALIA, the Biosafety Isolator is an enclosed isolation system designed to protect both the operator and the product from potential biological hazards. Here are the standout features that set it apart:

Unmatched Airflow and Filtration

The isolator boasts ISO Class 5 unidirectional total exhaust airflow, ensuring a sterile workspace throughout the manufacturing process. This is complemented by a dual exhaust HEPA filter using the Bag-In Bag-Out (BIBO) system, which minimizes accidental exposure during filter replacement.

Real-Time Monitoring and Automatic Protection

Real-time monitoring of the inner chamber’s air tightness is ensured through advanced alarm systems, safeguarding against unexpected exposure risks. In emergencies, such as door seal or glove damage, an automatic protection system activates to maintain inward airflow, keeping the environment safe and secure.

Robust Construction and Compliance

Built with a full-welded stainless steel structure, the isolator meets international cGMP standards and passes stringent pressure decay tests with no leakage below +750pa. It also complies with ISO 10648-2 and ISO 14644-1 standards, ensuring a high level of containment and air cleanliness.

Customization and Adaptability

The QUALIA Biosafety Isolator is designed with flexibility in mind:

Adaptive Exhaust Systems

These systems can be configured to meet specific user needs, including options for in-situ decontamination and scanning devices. This adaptability ensures that the isolator can be tailored to various applications, from sterile production to handling sensitizing or toxic substances.

Standalone Control Modules

The isolator features standalone control modules that simplify electrical maintenance and offer the option to use Siemens industrial computers or touch screens. This plug-and-play capability is particularly beneficial for clients without access to 100% duct systems, achieving pressures up to -250Pa.

Innovation and Integration

QUALIA’s commitment to innovation is evident in several aspects:

Modular Design

Large isolators can be assembled on-site, avoiding transportation issues and ensuring ease of installation. Built-in VHP generators are an optional feature, ensuring operational safety and sterilization reliability.

Professional Verification

Comprehensive verification services are provided, ensuring validation at every node. This meticulous approach guarantees that every aspect of the isolator is designed and verified to the highest standards.

Compliance with International Standards

The QUALIA Biosafety Isolator adheres to a range of international standards, including:

• 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.

Conclusion

The QUALIA Biosafety Isolator is more than just a piece of equipment; it is a safeguard for your work and your well-being. With its advanced features, customizable options, and strict adherence to international standards, this isolator is a must-have for any laboratory or manufacturing facility that demands the highest levels of biosafety and sterility. Whether you are working with sensitive biological materials or toxic substances, the QUALIA Biosafety Isolator ensures a safe, sterile, and compliant environment, making it an indispensable tool in the field of biological research and pharmaceutical production.