Search results for "aseptic filling"

Article Aseptic Processing: Keeping it Safe
Protecting operators Protecting drug product from microbial contamination is a key concern when making biologics, which is why aseptic filling typically occurs in a positive pressure isolator. In …

Article Defining Risk Assessment of Aseptic Processes
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs. By Susan J. Schniepp Q: I work in …

Article Automation Trend in Fill/Finish Reduces Contamination Risk
By Feliza Mirasol  Aseptic filling is a crucial process in biopharmaceutical manufacturing because it has a potential safety impact on the end user and because aseptic filling is a highly tec…

Article Ensuring Sterility in Small-Scale Production
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses how to ensure sterility when manufacturing small-scale parenteral batches. By Susan J. Schniepp Q. I am a …

Article Modular Manufacturing Platforms for Biologics
They can also include configurable skids; process modules/skids based on single-use equipment; or unit operations within modules, such as suites made exclusively for aseptic filling of prefilled syrin…

Article Bioterminology: A Guide to the Biopharmaceutical Lexicon
Bioterminology: A Guide to the Biopharmaceutical Lexicon This lexicon was generated by the editors of BioPharm International magazine. Please feel free to email your suggestions for terms that s…

Article Best Practices in Qualification of Single-Use Systems
The author discusses the current best practices in technical qualification of single-use systems. By Weibing Ding, PhD Single-use technology has been around for approximately two decades if …

Article Upstream, Downstream Processing in Motion
GE Healthcare Life Sciences' ReadyToProcess platform aims to streamline bioprocessing applications. The need to streamline operating costs in biopharmaceutical processing applications has en…

Article Practical considerations for demonstrating drug substance uniformity
The authors describe considerations and best practices for meeting drug substance uniformity. By Sushil Abraham, Eric Rydholm, and Phil Wagner ABSTRACT Drug-substance uniformity is an impo…

Article The New World of Biopharmaceutical Manufacturing
Industry experts discuss the single-use revolution and changes to upstream and downstream processing equipment. By Jennifer Markarian …

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