RABS vs Isolators: Understanding the differences

By Esco Healthcare 07 December, 2016

During the last 2 decades, aseptic processing has advanced with the use of isolators and Restricted Access Barrier Systems (RABS) as a means of detaching the operator from “critical areas” thereby reducing potentials risks in products. These systems have been slowly replacing traditional cleanroom.

But what exactly are the differences between these two systems?

Restricted Access Barrier System (RABS)

Includes Compounding Aseptic Isolator (CAI) or Compounding Aseptic Containment Isolator (CACI)
Provide an ISO Class 5 environment for preparing Compounded Sterile Preparations (CSPs)
All transport ports must be closed during compounding
Located within at least ISO Class 7 area to prepare Category 2 CSPs, or within a segregated compounding area to prepare Category 1 CSPs

Isolator

Provides isolation from the surrounding area and maintains ISO Class 5 air quality
High-integrity transfer ports
Decontaminated using an automated system
Maintains constant overpressure of at least 0.05-inch water column
Can be located in an ISO Class 8 area when preparing Category 2 CSPs

Criteria	RABS	ISOLATOR
Decontamination	Manually disinfected	Quantifiable and high reproducible method by an automated system
Assurance of Separation	No complete physical separation	Quantifiable hourly leak rate (closed) and continuously controlled differential pressure
Surrounding Environment	Passive: ISO 5 Active: ISO 7	Quantifiable leakage tightness (ISO 10648-2)
Capital Costs	Higher than conventional cleanroom (CCR); reduced with renovation and retrofit application	HIgh equipment costs
Operating Costs	Higher than CCR	Cost saving in energy consumption (HVAC) and clothing
Toxic Containment	Low Capability	Good reliability