OUR COURSES

Isolators, RABS technologies and associated processes

Course Details

Module length  
1 DAY
Learning tools  
Presentations, Lectures, Case Studies, Discussion, Question & Answers session, Final evaluation test

 

Target audience  
Manufacturing, Quality Assurance, Validation, Engineering, Maintenance

Agenda

Separation and Isolation concept, contaminant generation and control strategies
Risk Assessment, Risk mitigation and Quality by Design
EU-Annex 1 revision contents
Process segregation Techniques
RABS and ISOLATORS
  • RABS features and requirements
  • Isolator features and requirements
  • Physical and Aerodynamics containment vs Segregation Level
Operational and Maintenance Aspects
Inspection points to consider from DOC experience
Case Studies from DOC experience

Regulatory & technical references

  • EU GMP Annex 1: “Manufacture of sterile medicinal products”
  • PIC/S Code of GMP PE009-11 Annex 1: “Manufacture of sterile medicinal products”
  • PIC/S PI 014-3 Recommendation - Isolators Used For Aseptic Processing And Sterility Testing
  • USP <1208> Sterility Testing - Validation of Isolator System
  • ISO 14644-4 “Cleanrooms and associated controlled environments: Design, construction and start-up"
  • ISO 14644-7 “Cleanrooms and associated controlled environments: Separative Devices (clean air hoods, gloveboxes, isolators and mini-environments)”
  • ISPE Baseline Guide: Sterile Product Manufacturing Facilities
  • PDA – TR 34 - Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products"
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