What is Changing in the Realm of Validations Regarding Reusable Devices?
Over the past decade, regulatory agencies have increasingly tightened requirements regarding reprocessing validations for reusable medical devices....
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Changes in the Packaging Environment Relating to Regulations and Test Methods
In today’s complex and ever-changing world, packaging faces its own set of evolving challenges, particularly in light...
Radiation Sterilization Strategies for Improved Processing Options and Timing
In the current landscape of supply and material constraints, the increased popularity of radiation sterilization has led...
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...
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...