Documenting Device Changes in Biological Risk Assessments: Part Two
This whitepaper, the second in a four-part series covering different examples of device changes to be documented...
Browse Content
Transitioning From Cell-Based Assays to qPCR-Driven Analyses To Ensure Viral Safety in Biologics Manufacturing
The production of biological products in biopharmaceutical manufacturing involves significant risks of viral contamination from human and...
Testing of High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol
Contamination from ethylene glycol and diethylene glycol in liquid formulation poses a high risk to patient safety....
Disinfectant Efficacy Testing on Site-Specific Surfaces
This whitepaper focuses on the importance of disinfectant validations based on real-world conditions to maintain cGMP compliance...
Documenting Device Changes in Biological Risk Assessments: Part One
“Device changes can range in complexity, making it critical that each change be treated uniquely and assessed...
Reprocessing Rethought: An Open Forum Discussion On Novel Decontamination Methods for Reusable Medical Devices
As reusable medical devices have advanced, the importance of effective decontamination methods (cleaning, disinfection, and/or sterilization) has...
Updates to ISO-18562:2024 – A CRO Point of View
The 2024 updates to the ISO 18562 series of standards bring quite a few changes. In this...
Unmasking the Unknown: How Mass Spectrometry Delivers Accurate Identifications
In this webinar, presented by our Senior Expert LC/MS, Ruud Cuyvers, you’ll expand your knowledge on unexpected impurities in Drug...
Focus on Fundamentals: Day 3 – Toxicological Considerations of VH2O2 Sterilization Residuals
VH2O2 sterilization may leave hydrogen peroxide residuals on the device materials after the sterilization process whose toxicological...
Focus on Fundamentals: Day 2 – Considerations for Biocompatibility
Biocompatibility assessments involve extensive evaluation, and changing the sterilization modality, such as to VH2O2, can trigger considerable,...