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PHSS Technical Monograph No 15

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Description

Restricted Access Barrier Systems (RABS) Definition, Classification, Specification and Use for Aseptic and Related Processing

ISBN: 978-1-905271-22-1

The definitions, operating methodologies and best practice defined in this monograph have had review from international regulators (MHRA & FDA) and is set to become the harmonised guidance document for the Industry and regulators.
Following the release of the PHSS RABS White paper (in 2010) this detailed monograph provides information on definitions, design, decontamination, use and monitoring of RABS.

Monograph Sections
1. Restricted Access Barrier Systems (RABS) overview and definition.
2. PHSS RABS classifications, types and operating methodologies.
3. RABS: Types of systems and configurations.
4. Access and transfer devices; Type classifications including glove systems and component transfer systems across the RABS/ External environmental barrier.
5. The risk based approach to RABS selection, specification, operation and compliance.
6. The key criteria for RABS type selection. Check list for User Requirements Specification (URS).
7. RABS design principles – key attributes to ensure contamination control.
8. Materials of construction, including compatibilities of processes and disinfection agents.
9. RABS Control systems.
10. Environmental control and monitoring. Air pressure differentials and Flow control. Particle monitoring and viable air sampling. Monitoring of RABS associated processes.
11. RABS leak integrity to monitor effectiveness of process containment or sporicidal gas/ vapour containment (as required for safety reasons during disinfection).
12. Cleaning and Disinfection. High level manual disinfection and sporicidal gassing.
• Definitions of terms used.
• References and acknowledgements.
• Appendix 1.
Example: Sporicidal gassing cycle development and qualification.
• Appendix 2.
Example: Regulatory compliance verification and qualification checks and tests.
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