In the realm of pharmaceutical and biological research, maintaining a sterile and safe environment is paramount. QUALIA, a leading manufacturer in the field, offers a range of isolators that cater to various needs, including aseptic isolators, sterility test isolators, and biosafety isolators. Here, we delve into the key features and benefits of these advanced isolation systems.
Compliance and Standards
QUALIA's 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 the handling of hazardous drugs.
Sterility and Safety
Air Filtration
These isolators incorporate advanced HEPA filters that comply with IEST-RP-CC001.3 and EN 1822 standards, achieving an efficiency of >99,999% at 0.1-0.3 micrometers. This ensures ISO Class 5 air cleanliness, providing exceptional environmental control.
Pressure and Airflow
The isolators can be configured to operate in either positive or negative pressure modes. Positive pressure is suitable for sterile, non-hazardous materials, while negative pressure is designed for containing hazardous substances. The systems utilize either recirculating or total exhaust airflow schemes to maintain a sterile environment.
Advanced Features
Dual Exhaust HEPA Filter
The biosafety isolators are equipped with a dual exhaust HEPA filter through the Bag-In Bag-Out (BIBO) system, minimizing accidental exposure during filter replacement. This ensures safe maintenance and protects both the personnel and the external environment.
Real-Time Monitoring
The isolators feature real-time monitoring of the inner chamber’s air tightness with alarm systems that activate if the set values are exceeded. This safeguard prevents unexpected exposure risks and maintains inward airflow in case of special risks or emergency faults.
Modular Design
The modular design of these isolators allows for on-site assembly, avoiding transportation issues. This flexibility is particularly beneficial for large isolators.
Integrated Control Systems
QUALIA's isolators come with standalone control modules for easier electrical maintenance, reducing time and cost. Users can choose Siemens industrial computers or touch screens for operation and parameter monitoring.
Customization and Adaptability
Pressure Decay Test
The isolators perform a pressure decay test with a performance of +1000pa for 20 minutes with no leakage below +750pa, ensuring high containment levels.
Material and Construction
The isolators have a stainless steel structure with superior full-welding and fine detail treatment. The interior weld surface roughness is up to 0.3um, enhancing durability and contamination control.
Adaptive Exhaust Systems
The exhaust systems can be separately configured to user needs, including options for in-situ decontamination/scanning devices. This allows for achieving sterile A-grade environments tailored to specific requirements.
Table: Types of Isolators by QUALIA
| 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) |
Conclusion
QUALIA's aseptic isolators and biosafety isolators are designed to provide a sterile and safe working environment, crucial for various applications in pharmaceutical and biological research. With their advanced features, strict adherence to international standards, and customizable options, these isolators are indispensable tools for maintaining high levels of sterility and safety.
By integrating these isolators into your workflow, you can ensure that your processes are free from contamination, protecting both your personnel and the integrity of your research or production. Whether you are dealing with sterile compounds, hazardous substances, or specific pathogen-free environments, QUALIA's isolators offer the reliability and precision you need.
