Search results for " aseptic"
Article
Aseptic Processing: Keeping it Safe
Aseptic processing has garnered some increased scrutiny from FDA in recent years, primarily because it is considered a high-risk activity by the agency, says Rainer Newman, consultant at Aseptic Proce…
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Defining Risk Assessment of Aseptic Processes
Schniepp
Q: I work in the quality group for a manufacturer who makes intravenous (IV) injectable drugs using aseptic processing techniques. Recently, the facility has experienced an increase in the…
Article
Cytiva Acquires Vanrx, Innovator in Aseptic Filling
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Cytiva acquires Vanrx to extend its single-use manufacturing platform with aseptic-filling solutions.
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
In fact, some of the batches might be manufactured under a laminar flow hood by manual aseptic processing. It is important to remember that sterility assurance of the product must be maintained even w…
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Single-Use Technologies Prove Effective for Viral Vector Process Development
Rocking bioreactors, fixed-bed bioreactors, and stirred bioreactors do enable aseptic, closed operations and are amenable to automation. They are also designed to increase cell-culture density while m…
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Selecting a Comprehensive Bioburden Reduction Plan
Personnel Training
BioPharm: Does operating personnel need specific training on bioburden reduction?
Souza: The manufacture of biologics requires operators trained in aseptic techniques, with …
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…
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Implementing QbD in Sterile Manufacturing
Critical quality attributes
BioPharm: In implementing a QbD approach, what would you identify as the critical quality attributes (CQAs) in sterile manufacturing and aseptic processing?
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Article
Strategizing for Rapid Changeovers in Biologics Manufacturing
“Although barrier isolation technology provides the highest level of aseptic processing, long bio-decontamination cycle times remain one of the biggest challenges for achieving a rapid changeover,” he…