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News RABS vs Isolators: Understanding the differences

RABS vs Isolators: Understanding the differences

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RABS vs Isolators: Understanding the differences

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

Source: Innovation in Aseptic Manufacturing RABS versus Isolators by Francesco Longanesi (Feb 2008)

 

Esco offer ISOLATORS apt for your compounding needs!

 

ESCO RABS

Closed Restricted Access Barrier System (SLC-RABS)

Streamline® Closed Restricted Access Barrier System (SLC-RABS)

Compounding Isolator

Streamline® Compounding Isolator

Containment Isolator - Class III

Streamline® Containment Isolator - Class III

 

ESCO ISOLATORS

General Processing Platform Isolator (GPPI)

General Processing Platform Isolator (GPPI)

Healthcare Platform Isolator - With Filter Below Workzone

Isoclean® Healthcare Platform Isolator - With Filter Below Workzone

Containment Barrier Isolator (CBI) - Undirectional

Containment Barrier Isolator (CBI) - Undirectional