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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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...
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...
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...
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....
Biocompatibility Fundamentals for Medical Devices
This comprehensive eBook serves as an essential guide for professionals involved in the design and manufacture of...
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...