What is a Hydrogen Peroxide Vapor Isolator System?

A hydrogen peroxide vapor isolator system utilizes a combination of air filters and vaporized hydrogen peroxide to create a controlled environment with a 6-log sporicidal kill on exposed, hard, non-porous surfaces in the workspace's interior chamber. This allows operators to do their work safely (via isolator gloves) by reducing the risk of inside/outside cross-contamination.

How Do Hydrogen Peroxide Vapor Isolator Systems Work?

The vapor generator inside the isolator system or connected to the system flash vaporizes the hydrogen peroxide solution into the environment, filling the internal chamber and covering exposed surfaces inside it. This allows the vapor to provide uniform coverage on irregular shapes that other decontamination methods would potentially miss.

Hydrogen peroxide vapor, such as the 35% solution of Bioquell Hydrogen Peroxide Sterilant (EPA Registration Number 72372-1-86703), provides a 6-log sporicidal kill. This means you can kill microorganisms that may contaminate your workstation through accidental exposure or from previous work inside the chamber (when used according to the label directions for use). Isolators with an EPA registered sterilant hydrogen peroxide vapor integrated in them provide validated cycles that may even be able to be preprogrammed to ensure repeatability.

Isolators such as the Bioquell Qube host such integrated technology and offer HEPA filtered unidirectional airflow to ensure acceptable non-viable and viable particle levels measured through environmental monitoring sensors hosted in the chamber.

In addition to creating and maintaining aseptic conditions, isolator systems have a number of features that improve your workflows. Elles peuvent comprendre :

• Rapid transfer ports
• Sterility test pumps (integrated or desktop)
• Remplissage du lave-vaisselle
• Environmental monitoring

How Long Does Implementation of an Isolator System Take?

Getting started with hydrogen peroxide vapor isolator systems involves these steps typically:

• A review of needs and processes
• Order and manufacture
• Delivery and installation
• Validation and implementation

But the amount of time depends on the material the isolator is built with.

The most common isolators are built with steel. Their large size, extreme weight and specialized parts translate into longer lead times. The average stainless steel isolator system can require customization and specificity that can 6-12 months to deliver, install and validate.

In contrast, there is a polypropylene option available for a more rapid installation method due to its unique build. The Bioquell Qube offers a lighter, easy assembly and eliminates the need for third-party involvement as the system is developed, tested, installed and validated by one provider. Many facilities can get started in 3-4 months from date of order as a result.

What Applications Are Isolator Systems Ideal for?

Because isolator systems can create and maintain aseptic environments, they’re ideal for a wide range of life sciences applications.

Sterility testing is one of the most widely adopted applications for hydrogen peroxide vapor isolators. That's because isolators create the perfect environment for identifying batch contamination. The contained environment helps to mitigates the risk of false  positives that delay batches and create waste. An isolator system such as the Bioquell  Qube also allows for this testing to be done in a lower grade environment, freeing up  highly coveted space and making the system quicker to access.

Cell therapy involves complex processes that requires work to be done quickly and with no risk of contamination. A single breach in sterility during a stage like incubation can ruin an entire project. An isolator system helps you perform numerous steps quickly and safely in an environment that won't impact the product or risk exposing immune compromised patients to an unexpected contaminant.

In addition to sterility testing and cell therapy, life sciences professionals use isolator systems for a number of applications requiring an aseptic environment:

• Production de petites quantités
• Biotechnology and drug development
• Product compounding
• Aseptic processing
• Préparation cytotoxique