Biosafety Isolator

Different Types of Isolator

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 Biosafety Isolator?

The “Biosafety Isolator” is a proprietary enclosed isolation system developed and manufactured by Shanghai QUALIA. It is designed for OEB production protection as well as for sterile production, aseptic experiments, biological experiments for biosafety, production involving sensitizing/toxic substances, and the breeding of Specific Pathogen Free (SPF) level laboratory animals.

Features of QUALIA's Biosafety Isolator

The Biosafety Isolator, developed with precision, upholds internationally recognized standards and caters to a variety of safety requirements with superior construction and integrated control systems.

Sterility and Safety:
- Provides ISO Class 5 unidirectional total exhaust airflow, ensuring a sterile work area throughout the manufacturing process.
- Equipped with a dual exhaust HEPA filter through the Bag-In Bag-Out (BIBO) system, minimizing accidental exposure during filter replacement.
- For added safety, protective handles are ensured on doors and the option to real-time monitor the inner chamber’s air tightness with alarm systems exceeding set values, safeguarding against unexpected exposure risks.
- In case of special risks or emergency faults like door seal or glove damage leading to isolator negative pressure imbalance, an automatic protection system activates to maintain inward airflow.
Customization and Compliance:
- High containment level with pressure decay test performance of +1000pa for 20 minutes with no leakage below +750pa.
- Stainless steel structure with superior full-welding, fine detail treatment, and interior weld surface roughness up to 0.3um.
- Adaptive exhaust systems that could be separately configured to user needs, including options for in-situ decontamination/scanning devices and achieving sterile A-grade environments.
Innovation and Integration:
- Standalone control modules for easier electrical maintenance, reducing time and cost, with the option to choose Siemens industrial computers or touch screens for operation and parameter monitoring.
- SCI Class III isolated units feature plug-and-play capabilities, ideal for clients without access to 100% duct systems, achieving pressures up to -250Pa with optional integrated fan exhaust module systems.
Design and Verification:
- Modular design for large isolators allows for on-site assembly, avoiding unnecessary transportation issues.
- Built-in VHP generators are an option for all isolators, ensuring operational safety and sterilization reliability, sharing a control system with the isolators for single-point validation and maintenance.
- Professional verification documentation and services are provided with all validation process control achievable at every node.

Compliance with Standards:

Meets international cGMP standards.
Conducts Class 3 pressure tests as per ISO 10648-2.
Maintains ISO 14644-1 air cleanliness at an ISO 5 level.
Offers quick purging times.
Complies with USP <797> and <800>.

Biosafety Isolator Gallery

QUALIA Biosafety Isolator Multi-Station Modular_1

QUALIA Biosafety Isolator's Gloves Details_1

QUALIA Biosafety Isolator Multi-Station Modular 2_1

QUALIA Biosafety Isolator Multi-Station Modular 1_1

QUALIA Biosafety Isolator Installation Site Processing 3_1

QUALIA Biosafety Isolator Installation Site Processing 2_1

QUALIA Biosafety Isolator Installation Site Processing _1

QUALIA Biosafety Isolator inside view with Bio-safety lsolation Damper Top installation in Integrity testing_1

QUALIA Biosafety Isolator FAT Integrity Test_1

Barry Liu

Hi, I'm Barry Liu. I've spent the past 15 years helping laboratories work safer through better biosafety equipment practices. As a certified biosafety cabinet specialist, I've conducted over 200 on-site certifications across pharmaceutical, research, and healthcare facilities throughout the Asia-Pacific region.

Related News

H2O2 Decontamination vs VHP: Choosing the Right Method for Your Facility

H2O2 decontamination and VHP are often used interchangeably, but they differ in application scale, cycle configuration, and regulatory recognition. This article compares aqueous hydrogen peroxide surface decontamination against vaporised hydrogen peroxide (VHP) sterilisation across parameters such as log reduction, material compatibility, cycle time, and regulatory acceptance for BSL-3/4 and GMP facilities.

Closed RABS in Biotech: Advancing Aseptic Processing

Discover how Closed RABS (Restricted Access Barrier Systems) enhance aseptic processing in biotech, providing a controlled environment with high protection against contamination and ensuring ISO Class 5 air cleanliness for sterile product manufacturing. Ideal for handling slightly toxic products and reducing operational costs.

FDA Regulations for Pharma Turnkey Projects 2025

Stay compliant with FDA regulations for pharmaceutical turnkey projects. Our 2025 guide covers key requirements and best practices.

Ensuring Precision and Safety: The Commissioning Services of QUALIA

In the intricate world of biosafety and biotechnology, the commissioning process is the linchpin that guarantees every system functions flawlessly and safely. At the forefront of this critical phase is QUALIA, a renowned name in the industry, known for its meticulous and comprehensive commissioning services. The Commissioning Process: A Cornerstone of Quality Commissioning is more than just a final check; it is a systematic process that verifies and documents every aspect of a biosafety system. QUALIA’s commissioning process begins at the design phase and extends through at least one year of operation, ensuring that each component meets the intended design criteria set by both QUALIA and its clients. Key Stages in Commissioning The commissioning journey at QUALIA is divided into several key stages, each designed

Maintaining Sterility: The Critical Role of Closed RABS in Pharmaceutical Production

Maintaining sterility in pharmaceutical production is crucial, and Closed RABS (Restricted Access Barrier Systems) play a vital role. These systems ensure high-level separation between operators and products, minimizing contamination risks and protecting both the operator and the environment. Learn how Closed RABS enhance aseptic processing and product safety.