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PDA PTC 1 Aseptic Processing-2023
Points to Consider No.1 Aseptic Processing
This document provides points to consider on topics related to the physical environment in which aseptic processing is conducted, monitoring of that environment, cleanroom personnel, material transfer, aseptic process simulation and validation, modern blow-fill-seal technology, cleaning, disinfection and sterilization, and critical utilities. It also includes points to consider on aspects of filter-integrity testing and water-for-injection (WFI) preparation. For additional information on specific topics, other PDA points to consider, technical reports, or similar documents are referenced.
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Parenteral Drug Association [pda]