Aseptic Isolator/ Sterility Test Isolators

Different Types of Aseptic Isolator/ Sterility Test 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)
Biosafety Isolator (Negative Pressure)	OEB Protective Isolator (Closed Type)

What is the Aseptic Isolator/ Sterility Test Isolators?

The Aseptic Isolator/Sterility Test Isolator is an enclosed isolation system developed and manufactured independently by Shanghai Qualia. It is specifically designed for Occupational Exposure Band (OEB) production protection and for sterile production, experiments, and biological safety protection. This innovative isolation system plays a crucial role in maintaining a sterile environment for various applications including aseptic experiments, biological experiments, production involving sensitizing/toxic substances, and the breeding of Specific Pathogen Free (SPF) grade experimental animals. Its primary function is to ensure that processes carried out within its confines are free from contamination, providing an aseptic environment that meets high standards of sterility and safety.

The Aseptic Isolator / Sterility Test Isolators provide a sterile environment for aseptic and aseptic compounding, designed in compliance with USP <797> and <800> standards. These isolators are preconfigured at the factory to operate in either positive or negative pressure modes, and are designed to utilize either recirculating or total exhaust airflow schemes.

Features of QUALIA's Aseptic Isolator/ Sterility Test Isolators

QUALIA’s Aseptic Isolator / Sterility Test Isolators represent the pinnacle of sterile processing technology, designed to meet the rigorous demands of various aseptic environments. Key features include:

Compliance and Standards:

Adherence to international cGMP standards ensuring the highest level of manufacturing practices.
Alignment with USP <797> and <800> guidelines for pharmacy compounding and hazardous drugs handling.
Subjected to Class 3 pressure testing as per ISO 10648-2, ensuring optimal containment and isolation capabilities.
Achieves air cleanliness of ISO 14644-1 Class 5 standards, reflecting exceptional environmental control.

Advanced Filtration System:

Incorporates High-Efficiency Particulate Air (HEPA) filters complying with IEST-RP-CC001.3 and EN 1822, achieving >99.999% efficiency at 0.1 to 0.3 micrometers, thereby providing ISO Class 3 air cleanliness as per ISO 14644-1.
Optional Bag-In/Bag-Out (BIBO) HEPA filter configuration ensures safe filter replacement, sealing the filter within a bag before removal from the isolator unit, offering added protection to maintenance personnel and the external environment.

FDA Grade EPDM Static Seals:

Utilizes FDA-grade EPDM for static seals, enhancing the system’s durability and contamination control.

Controller and Monitoring:

Oversees all functions, providing real-time airflow and pressure monitoring to maintain optimal operational conditions.

Robust Double-Wall Construction:

Features a double-wall design with an exclusive plenum chamber using negative pressure to seal around the filter, ensuring integrity and containment.

Safe Sleeve Replacement Rings:

Allows for the changeover of vinyl sleeves without risking contamination of the workspace or external environment, crucial for handling potent (volatile) liquids or powder materials and preventing cross-contamination risks while ensuring operator and environmental protection.

Airlock Transfer Hatch:

Maintains sterility in the main workspace during material insertion and removal, equipped with an electromagnetic interlocking door mechanism featuring delayed entry and exit control.

Interchangeable Pressure Configurations:

The workspace and airlock transfer area can be configured for either positive or negative pressure operation.
- Positive pressure is tailored for sterile non-hazardous materials.
- Negative pressure is intended for containing sterile hazardous substances.

These isolators are tailored to facilitate a wide range of applications, bolstering safety, efficiency, and sterility in critical environments.

Custom Services of Aseptic Isolator/ Sterility Test Isolators

The configuration of the Aseptic Isolator / Sterility Test Isolators can be customized to meet individual factory specifications with options for recirculating or total exhaust/single-pass airflow systems:

The recirculating airflow is suited for preparing non-hazardous sterile medications, in accordance with the USP <797> guidelines for Compounding Aseptic Isolators (CAI).
For facilities dealing with volatile Hazardous Drugs (HD)/substances, a total exhaust/single-pass airflow is recommended, as both USP <797> and <800> clearly stipulate the use of Compounding Aseptic Containment Isolators (CACI) for handling volatile HDs.

Recirculating Airflow System

Inlet pre-filters and HEPA filters maintain ISO Class 5 air purity in the main chamber and pass-through with a consistent laminar flow.
The system recycles approximately 90% of the air, with the exhaust fan purging contaminated air and redirecting it through the filters back into the workspace.
The remaining 10% of exhausted air, filtered to remove heat, is compensated by pre-filtered ambient air.

Total Exhaust Airflow System

Positive pressure is generated by fans through pre-filters and HEPA filters, maintaining a downflow velocity within the isolator.
The entire system ensures an ISO Class 5 environment, providing unidirectional airflow to protect internal materials.
All air is quickly purged and completely exhausted through HEPA filters, ensuring environmental safety.