Search results for " aseptic" in Articles / App Notes

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…

Article 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 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…

Article Upstream, Downstream Processing in Motion
The support pieces that make everything work are also part of the platform, such as sterile filter assemblies, aseptic tube welders, and sealers as well as disposable, genderless, aseptic connectors. …

Article 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…

Article 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? …

Article Challenging the cleanroom paradigm for biopharmaceutical manufacturing of bulk drug substances
The process may also be kept closed by using presanitized hoses or tubing with single-use aseptic connectors. Open manipulation of the process stream Some operations, like inoculum expansion, …

Article Practical considerations for demonstrating drug substance uniformity
The buffer flush could alternatively be performed post autoclave/SIP of the filter, however, this adds complexity to the operation to ensure that the aseptic state of the equipment is not compromised …

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