Biocompatibility Fundamentals for Medical Devices
This comprehensive eBook serves as an essential guide for professionals involved in the design and manufacture of...
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The Road to Market Authorization for Sterile Medical Devices within the European Union
Sterile medical devices must adhere to the regulations and standards for CE marking that came into effect...
The Necessity of Extractables and Leachables Qualifications for Lyophilized Drug Products: Some Fallacies Addressed.
When selecting and qualifying the primary packaging for lyophilized drug products (LDPs), a fundamental question arises: How...
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...
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...
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...
Reactive Leachables
The reactivity of leachables is an area of growing concern, particularly for therapeutic proteins and peptides. These...
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...
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...
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...