Updates to Med Device E & L What about Chemistry on Limited Contact Devices
Recent feedback from global regulatory bodies has increasingly emphasized the necessity of extractables and leachables (E&L) chemistry...
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Biocompatibility Fundamentals for Medical Devices
This comprehensive eBook serves as an essential guide for professionals involved in the design and manufacture of...
Analytical Approaches used in E&L Studies from Basic Instrumentation to High-End, State-of-the-Art Equipment to Support Structural Elucidation
In this presentation at the 2022 Nelson Labs Virtual Symposium, attendees will be taken on a virtual...
Do’s and Don’t in setting up Extractables and Leachable Studies, taking into account Existing Standards Guidelines and Recommendations
During the production, storage, distribution, and administration of small volume parenteral (SVP) drug products, chemicals can leach...
N-Nitrosamines in Primary Packaging for SVP’s
Recent product recalls due to the unexpected presence of N-Nitrosamines have highlighted the critical need to understand...
Primary Packaging Considerations from a Biologics Product Development Perspective
In this presentation at the 2022 Nelson Labs Virtual Symposium, Dr. Mahler will provide a comprehensive overview...
Reactive Leachables
The reactivity of leachables is an area of growing concern, particularly for therapeutic proteins and peptides. These...
Rubber Oligomers: The “Special Case” compounds: Formation, Structure Toxicity & Reactivity
Rubber oligomers, originating from rubber closures (vials) or plungers (e.g., syringes or cartridges), represent a class of...
Setting up Extractables & Leachables Studies for Small Volume Parenteral Applications
In this presentation at the 2022 Nelson Labs Virtual Symposium, we will cover the general principles of...
The Challenges in Toxicological Assessments for Small Volume Parenteral Packaging System Applications
This presentation at the 2022 Nelson Labs Virtual Symposium will focus on the typical toxicological challenges encountered...