A RISK-BASED FRAMEWORK TO MANAGE SINGLE-USE SYSTEMS OVER LIFECYCLE: DESIGN, CLEANING, OPERATION, ONGOING PROCESS VERIFICATION

摘要

Using a formal risk management approach, SU systems (SUSs) and classical stainless steel-based systems (CSSs) are examined in detail. The risk assessment steps include: identification, analysis, mitigation and reevaluation/verification of risks over lifecycle. Adequate risk tools are used for each step. Failure modes specific of each type of system, are considered. The scientific background described in BPOG's Guidelines on extractables (2014) and leachables (Jan.2017) for SUSs is built in, together with other authoritative sources for both types of systems.