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...
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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...
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...
Combination Products and Parenteral Packaging a US Perspective
This presentation at the 2022 Nelson Labs Virtual Symposium will provide a comprehensive overview of drug delivery...
Combination Products and Parenteral Packaging: A Notified Body (EU) Perspective
This presentation at the 2022 Nelson Labs Virtual Symposium will provide a comprehensive overview of the considerations...
Rubber Manufacturing and Composition of Pharma Rubbers
Rubber closures are a critical component in the primary packaging system of small volume parenterals (SVPs). At...
Radiation Sterilization of SVPP: RTU and fill/finished. Do not default to 25 kGy – 40 kGy.
At the 2022 Nelson Labs Virtual Symposium, we will present examples of radiation sterilization for Ready-to-Use (RTU)...