Documenting Device Changes in Biological Risk Assessments: Part Three
This is the third whitepaper in a four-part series covering different examples of how to document device...
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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...
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...
Container Closure Requirements: Preparing for USP
Container closure integrity, which is verified by container closure integrity testing (CCIT), is critical to ensure the...
Guidance on Combining Biocompatibility and Cleaning Validation Testing
Testing all biocompatibility endpoints for reusable medical devices both at first-time use and after multiple reprocessing cycles...
Pros Cons and Considerations of Using a Developmental Chamber During Ethylene Oxide Validation
A developmental chamber, typically smaller than a production chamber, is often utilized to perform studies that support...
A Stepwise Approach to Deal with In Vitro Cytotoxicity Failures
Manufacturers are required to perform a biological evaluation of any medical device as outlined in ISO 10993-1....
