The manufacture of sterile medicinal and therapeutic products increasingly calls for aseptic processing using barrier separation technology comprising isolators and restricted access barrier systems (RABS) that have glove-sleeve systems.
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James L. Drinkwater
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Completing risk assessments is an inherent part of good manufacturing practice (GMP) and risk-based environmental control and monitoring (EM) in sterile product filling within isolators and restricted access barrier systems (RABS). This article considers the challenges the pharmaceutical industry faces in characterising conventional risk assessments like failure modes and effects…