Search results for " leachables" in Articles / App Notes
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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Article
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…
Article
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…
Article
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…