Particulate Control in Single-Use System Manufacturing
A comprehensive framework for particulate control and quality assurance in cleanroom manufacturing of bioprocessing systems.
Abstract: This paper addresses the systematic approach to particulate control in cleanroom manufacturing of single-use bioprocessing systems. The framework encompasses multiple controlled environments, including ISO Class 7 cleanrooms and ISO Class 8 cutting rooms, with stringent environmental monitoring protocols. Production controls include real-time particulate monitoring, validated gowning procedures, and specialized material transfer processes. Quality assurance measures incorporate multi-stage inspection protocols, from receiving through post-gamma irradiation verification.
The process includes routine endotoxin testing to USP <85> standards (acceptance criteria <0.25 EU/mL) and particulate analysis per USP <788> and EP 2.9.19 specifications (≤25 particles/mL at ≤10μm; ≤3 particles/mL at ≤25μm).
