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...
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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....
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...
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...
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,...
Handling Unexpected Biocompatibility Test Results in Medical Device Development
Getting unexpected or failing test results for any biocompatibility test can feel like the end of the...
Biocompatibility Testing: What You Need to Know
When it comes to biocompatibility testing on medical devices, there are many aspects that have to be...
Biocompatibility as a Critical Design Input
For any medical device contacting a patient, a biocompatibility evaluation is required before the device can be...
Container Closure Requirements: Preparing for USP
Container closure integrity, which is verified by container closure integrity testing (CCIT), is critical to ensure the...