RABS & Isolator Technology
This pharmaceutical training course covers the A-Z of Isolator Technology and Restricted Access Barrier Systems (RABS) used in Aseptic Manufacturing.
The course also covers barrier system design and selection, covering areas such as: the risk of product contamination and the subsequent risk to patient; the types of systems available; ergonomics; types of sanitisation systems, e.g. vapour phase hydrogen peroxide (VPHP); air-handing system requirements, pressure regimes, device/surrounding area classification; monitoring systems; and the overall advantages and disadvantages of using Isolators or RABS over traditional Aseptic Manufacturing (advanced aseptic processing versus standard Grade A to B interfaces). It also provides an overview of all key applicable guidelines, standards and regulations, and will cover the origins (myths, legends and science) behind the standards currently used. The course will cover all implications of updates to EU Volume 4,Annex 1.
A detailed approach to the optimisation and qualification of sanitisation cycles will be included, together with requirements for operation, maintenance, testing, inspection and monitoring of the systems and environments involved. The course is heavily orientated towards basing decisions for design, qualification/verification, operation and routine monitoring/testing/inspection on risk to product quality and ultimately risk to patient.