Compliance and Validation Training Courses
Restricted Access Barrier Systems (RABS) & Isolator Technology
This course covers the design, installation, qualification and operation of isolator systems and restricted access barrier systems (RABS), as used in aseptic manufacturing. It looks at the choices of systems available and the advantages and disadvantages of using Isolators and RABS over traditional Aseptic Manufacturing. The course also covers system design (types of systems, ergonomics, air classification and air-flow requirements) and the qualification / verification of the equipment systems involved, including facility and HVAC systems for isolators/RABS and surrounding/supporting areas.
Also included in the course, is the development, optimisation and qualification of sporicidal decontamination cycles, together with requirements for operation, maintenance, testing, inspection and monitoring of the systems and environments involved. The impact of the new EU Vol.4 Annex 1 (Aug 2022) on the design, qualification and operation of RABS/isolator systems will be discussed, together with the latest developments in gloveless automated isolators.
Delegates will be provided with a 3-slide per page printed binder upon arrival on Day 1 and PDF versions of the slides will be sent out by email to each delegate after the course. Day-time meals and refreshments, together with a course dinner, held on the evening of Day 1 (Tuesday 12 Mar 2024), are included in the overall package.
