In the realm of biomedical research and pharmaceutical production, maintaining a sterile environment is not just a necessity, but a lifeline. Contamination can be catastrophic, leading to failed experiments, compromised products, and even health risks. This is where the QUALIA ISOSeries Aseptic Isolators step in, offering a cutting-edge solution that ensures the highest standards of sterility and safety.

What are Aseptic Isolators?

Developed and manufactured by Shanghai QUALIA, the ISOSeries Aseptic Isolators are sophisticated, enclosed isolation systems designed to protect against contamination. These isolators are tailored for various applications, including aseptic experiments, biological experiments, production involving sensitizing or toxic substances, and the breeding of Specific Pathogen Free (SPF) grade experimental animals.

Types of Isolators

QUALIA offers a range of isolator types to cater to different needs:

• Aseptic Isolator / Sterility Test Isolator (Positive Pressure): Available in Open Type (ORBS) and Closed Type (CRBS) configurations.
• Biosafety Isolator (Negative Pressure): Includes P3/P4 Biosafety Protective Isolators and OEB Protective Isolators, all in closed types.

Each type is meticulously designed to ensure optimal containment and isolation, whether for sterile non-hazardous materials or for containing hazardous substances.

Compliance and Standards

QUALIA's ISOSeries isolators adhere strictly to international cGMP standards, ensuring the highest level of manufacturing practices. They are aligned with USP <797> and <800> guidelines for pharmacy compounding and hazardous drug handling. These isolators undergo Class 3 pressure testing as per ISO 10648-2 and achieve air cleanliness of ISO 14644-1 Class 5 standards, reflecting exceptional environmental control.

Advanced Filtration System

The heart of these isolators is their advanced filtration system, which incorporates High-Efficiency Particulate Air (HEPA) filters. These filters comply with IEST-RP-CC001.3 and EN 1822 standards, achieving an efficiency of >99.999% at 0.1 to 0.3 micrometers. An optional Bag-In/Bag-Out (BIBO) HEPA filter configuration ensures safe filter replacement, sealing the filter within a bag before removal to protect both maintenance personnel and the external environment.

Robust Construction and Safety Features

The ISOSeries isolators boast a robust double-wall construction with an exclusive plenum chamber using negative pressure to seal around the filter, ensuring integrity and containment. They feature FDA-grade EPDM static seals for enhanced durability and contamination control. The airlock transfer hatch maintains sterility during material insertion and removal, equipped with an electromagnetic interlocking door mechanism for delayed entry and exit control.

Interchangeable Pressure Configurations

These isolators can be configured for either positive or negative pressure operation. Positive pressure is ideal for sterile non-hazardous materials, while negative pressure is designed for containing sterile hazardous substances. This flexibility makes them versatile tools in various laboratory and production settings.

Custom Services

QUALIA offers customized services to meet specific needs. The recirculating airflow system is suited for preparing non-hazardous sterile medications in accordance with USP <797> guidelines for Compounding Aseptic Isolators (CAI). For facilities handling volatile Hazardous Drugs (HD), a total exhaust/single-pass airflow is recommended, aligning with USP <797> and <800> guidelines for Compounding Aseptic Containment Isolators (CACI).

Conclusion

In a world where sterility is paramount, the QUALIA ISOSeries Aseptic Isolators stand as guardians against contamination. With their advanced filtration systems, robust construction, and adherence to stringent international standards, these isolators provide a safe and sterile environment for a wide range of critical applications. Whether you are involved in biomedical research, pharmaceutical production, or any field requiring utmost sterility, QUALIA’s ISOSeries is your trusted partner in maintaining the highest standards of safety and purity.