Search results for " leachables"
Article
Quality by Design and Extractable and Leachable Testing
Therefore, potentially harmful leachables, including (but not limited to) metals, catalysts, antioxidants, curing agents, activators, accelerators, pigments, stabilizers, plasticizers, and lubricants …
Article
Assessing leachables risk over a complete single-use, mAb process
In an article, process equipment-related leachables are mapped over a complete single-use mAb process at pilot scale.
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Single-Use Extractables and Leachables: Cytiva's Alignment with the BPOG Protocol
Despite years of discussion and experience, E&L testing approaches for single-use equipment have not yet fully matured into a consensus industry practice. Copious amounts of data have been generated…
Article
Evaluating E&L Studies for Single-Use Systems
Extractables and leachables evaluation
An extractables and leachables evaluation should begin with a risk assessment of the materials to determine whether there is a significant risk that may requ…
Article
Advancing Single-Use Technology Through Collaboration
Concerns such as extractables and leachables, visible particulate contaminants, and system integrity may prevent some manufacturers from more widespread adoption of single-use technology. Industry gro…
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Eliminating Residual Impurities Starts with a Strategic Plan
At this time, one area that is not currently regulated in detail by the health authorities is extractables and leachables. “Biopharmaceutical manufacturers have to establish ‘in-house’ risk-based stra…
Article
Aseptic Processing: Keeping it Safe
…ical and physical) with the intended final product, providing adequate stability with low risk [for] leachables.” The new container or closures would also have to fit with the processing facility wit…
Article
CMOs Concerned With Cost of Single-Use Equipment
One area that CMOs indicate has not been worked out is leachables and extractables. For example, 13% of CMOs worry for the lack of regulatory guidance on L&E—noting this as their top obstacle. In comb…
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Best Practices in Qualification of Single-Use Systems
For example, a single-use bioreactor should be sterile and not adversely affect cell growth due to certain leachables. It should provide sufficient mixing and have acceptable gas exchange, and should …
Article
Securing the Single-Use Supply Chain
Dual sourcing is one of many possible solutions to securing the supply chain.
Single-use systems (SUS) have become established in biopharmaceutical drug development. As confidence in the technol…