Why Accurate Nitrosamine Data Matters: Key Challenges and Considerations
In any N-Nitrosamine risk assessment it is critical that analytical data used in such assessments is accurate. ...
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Reprocessing Rethought: Single-Patient, Home-Use Devices
Cleaning, disinfection, and sterilization processes for reusable medical devices are intended to mitigate the transmission of infection...
Radiation Microbiology in Pharmaceutical Products
Microbiological testing on pharmaceutical products can sometimes be confusing, especially when dealing with sterilized components or a...
Radiation Microbiology, Past, Present, and Future
This webinar presented by the International Irradiation Association (iia) on 15th July, 2026, explores key aspects of radiation microbiology, including...
How to Avoid Chemical Characterization Pitfalls in Medical Devices
Medical device chemical characterization testing per ISO 10993-18 is often the leading source of delay, cost overrun,...
Beyond LAL: The Future of Endotoxin Testing Is Recombinant
Bacterial endotoxins can negatively impact the quality and effectiveness of pharmaceutical products, medical devices, and other materials....
What does risk-based biocompatibility under the new ISO 10993-1 really look like?
The era of the "checklist" approach to biocompatibility is officially over. With the publication of ISO 10993-1:2018...
Endotoxin Retention Testing for Filters
Bacterial endotoxins can negatively impact the quality and effectiveness of pharmaceutical products, medical devices, and other materials,...
Ensuring Drug–Device Compatibility: Foundations for Safe and Effective Combination Products
As combination products continue to advance healthcare, ensuring compatibility between drug formulations and device components is essential...
Reprocessing Rethought: Mastering the Worst-Case Soil Challenge
To perform cleaning validations according to ANSI/AAMI ST98:2022, the intended use and clinical conditions of medical devices...