Transcription of Restricted Access Barrier Systems & Isolators
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Restricted Access Barrier Systems & Isolators
Restricted Access Barrier Systems & IsolatorsGordon FarquharsonJuly 2017 Slide 2 PharmOut 2017 Learning objectivesWe will Learn What Isolators are and why they were developed The difference between a RABS and an isolator The fundamental types of Isolators The basics of isolator design and how materials are aseptically transferred to the isolator interior How Isolators are decontaminatedSlide 3 PharmOut 2017 Cleanroom contamination People are the greatest source of bio-contamination in the manufacture of sterile products. Separation of the people from the aseptic zone is the best method for controlling contamination. Physical Barrier segregation is the method of choiceSlide 4 PharmOut 2017 Increasing system integrityIncreased sterility assuranceRABSI solatorsThe aseptic integrity spectrum Advanced aseptic processingSlide 5 PharmOut 2017 Characterising The Technologies PharmOut 20155 Slide 6 PharmOut 2017 Traditional cleanroom characteristics Grade B/ISO7 Room scale critical environment contains operators Critical Grade A/ISO5 Aseptic process Corelocated in the Grade B/ISO7 room Operators open equipment from surrounding Grade B/ISO7 room to load the process and intervene using defined SOPs.
Slide 2 © PharmOut 2017 Learning objectives We will Learn • What isolators are and why they were developed • The difference between a RABS and an isolator
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