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...
Medical Packaging and the Impact of NO2 Sterilization
Novel sterilization modalities are becoming increasingly prevalent in the healthcare industry, offering new solutions for ensuring the...
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...
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...
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...
