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....
Archives: Courses
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...
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...
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...
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...
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...
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...
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...
A Structured Approach to Selection of Container Closure Materials for Small Volume Parenterals – Pipe Dream or Necessity
In the upcoming 2022 Nelson Labs Virtual Symposium, this presentation will emphasize the importance of selecting materials...
E&L Testing of Single-Use Systems for Production
In the 2022 Nelson Labs Virtual Symposium, this presentation will focus on the critical issue of leachables...
Manufacturing an SVP Drug Containment Solution: Quality by Design
The 2022 Nelson Labs Virtual Symposium will offer an in-depth look at the considerations necessary when choosing,...
Polymer-based, Pre-filled Syringes designed to Minimize the Aggregation Risk of Sensitive Biodrugs
Biopharmaceutical drugs offer new therapeutic solutions to numerous human diseases and conditions. However, these advanced therapies come...