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 and operation of RABS/isolator systems will be discussed, together with the latest developments in gloveless automated isolators. Attendees will receive PDF file versions of all the presentations by email. Presentations for each day will be sent out the day before the start of the respective day of the course.