CCR RABS & Isolators

Ensure you receive the optimum barrier solution for your facility.

What are Barrier Systems?

A physical barrier which separates the operator from the process.

As important as the barrier itself are the linked features and processes such as:
Properly designed equipment (ergonomics) and HVAC system.

Material transfer procedures.

Working procedures and training of the operators.

Procedures in terms of intervention and accidents.

Conventional Clean Rooms (CCR)

• ISO 5 (class A) surrounded by ISO 7 (class B) room
• Pressure difference (15 Pa) between the clean room classes
• Critical operations with open sensitive products are carried out under Unidirectional Airflow (class A protection)
• Manipulations (i.e. trouble shooting, change of format parts) are done directly by opening of the machine cladding
• Operator gets directly in contact with critical surfaces (class A area)
• Gowning of the operator according to class B requirements
• Material transition to class B (autoclave, pass box, dry heat oven)
• Regular wipe sanitization
• Heavy routine viable monitoring
• Periodical room sanitization

Restricted Access Barrier System (RABS)

• Surrounding clean room class B for the filling operation
• Pressure difference (15 Pa) between the clean room classes
• All manipulations during production are done via gloves of the RABS
• Ergonomic designed system for the process inside (Mock-up studies)
• Transfer of format parts via Rapid Transfer Port (RTP)
• Material transfer via RTP or material locks
• Gowning of the operator according class B requirements
• Conventional cleaning and disinfection
• Same viable monitoring as CCR
• Locked doors (barrier) during operation
• The system isolates the operator from the critical areas to increase Sterility Assurance Level (SAL)

Isolator

•ISO 5 (class A) inside isolator
• Surrounding clean room ISO 8 (class D or C) for the filling operation
• Positive pressure difference towards the filling room
• Ergonomic designed system for the process inside (Mock-up studies)
• Complete closed system with Vaporized Hydrogen Peroxide (VHP) decontamination of all surfaces
• Complete independent HVAC-unit
• All manipulations during production are done via gloves
• Gowning of the operator according class C or D requirements
• Material transfer via RTP or material locks
• Area to be monitored is very limited
• Very high SAL

CCR RABS Isolator
Validation, start-up risk Low Low High
Necessity of experts Low Low High
Skill of personnel Medium Medium High
Investment, equipment Low Medium High
Investment, building High High Low
FMC high cost countries High High Low
FMC elsewhere No real difference
Suitability for campaigning Low Medium High
Sterility Assurance Level (SAL) Low Medium High
Regulatory scrutiny High Low Low
Risk – SAL – Media Fill High Medium Low
Microbial Sampling Normal Normal Less
Suitability for processing potent drugs Not given Limited Very good
Maintenance complexity Low Medium high
Access for service Easy Restricted Restricted
Realization time Low Medium high