Isolator and RABS (Restricted Access Barrier Systems) are used to control contamination in the production of pharmaceuticals and other medicines manufactured in an aseptic environment.
Both isolator and RABS provide physical barriers to protect the product as well as the worker from potentially hazardous chemicals. They are often used during critical processes to safeguard the product from viable organisms and particulate contamination.
Key Differences
There are key differentiators between isolators and RABS. Each system has unique validation systems and levels of leak tightness. Additionally, RABS should be contained within an aseptic zone, whereas an isolator does not need to be in an aseptic area.
According to this source, the main difference between closed RABS and isolators is that closed RABS have no automated bio-decontamination cycle using H2O2 vapor or another sanitizer. The interior of the closed RABS unit is bio-decontaminated manually using cleaning solutions.
According to the ISPE, RABS have several unique design characteristics
- Rigid wall enclosure
- ISO 5 unidirectional airflow in the critical area (ISO 7 in the room in operation)
- Sterilization-in-place (SIP) for parts in contact with a liquid product, if possible
- Sterilization in an autoclave and aseptic assembly (a piece of tubing product)
- Autoclave sterilization for parts in contact with the product
- Materials entry through transfer systems that prevent the exposure of sterile surfaces to less clean classification environments
- Use of glove ports
- Disinfection of all parts without direct contact before each batch
Unlike a RABS, an isolator doesn’t necessarily have to be located within an aseptic zone. These units are so-called containment isolators, and their mission is to contain the product, preventing the operator to be exposed to it.
Isolators are defined as sealed enclosures that may contain a qualified controlled environment and are at variance with the surrounding conditions designed and tested to a level of leak tightness to international standards, typically ISO 14644-7 and ISO 10648-2.
What are Isolator/RABS Gloves?
There are several types of isolators gloves:
- Type 1 – Isolator gloves are used for containment glovebox and isolation glovebox.
- Type 2 – Used for full-size isolators/RABS
Benefits of Nitrile Isolator Gloves
- Protect products from contamination
- Protect workers
- Nitrile provides excellent protection, reliability, and longevity
- FDA approved polymer
- Anti-static properties
- Performs well with IPA and VHP
- Suitable for autoclaving
- Excellent chemical resistance
- Over 4 hours of permeation protection against cytostatics
- Can be sterilized or sanitized by gamma irradiation, vaporized hydrogen peroxide (VHP), isopropyl alcohol (IPA)