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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Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
For most biologics, therefore, sterility must be assured by using aseptic processing techniques, which involve use of sterile raw materials, equipment, and processes under conditions that prevent micr…
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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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