Focus on Fundamentals: Day 1 – VH2O2, Sterilization Considerations
VH2O2 has been a common sterilization option for reusable devices for many years. Interest has increased for...
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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...
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....
Biocompatibility Testing: What You Need to Know
When it comes to biocompatibility testing on medical devices, there are many aspects that have to be...
Advancing Microbial-Contamination Detection Through Rapid Sterility Testing
Increasing industry and product demand for expedited product release reinforces the need to embrace rapid sterility technologies....
What’s New with Reprocessing Validations for Reusable Medical Devices?
There have been many great strides surrounding the guidance for reprocessing (cleaning, disinfection, and/or sterilization) validations for...
Disinfectant Efficacy Testing on Site Specific Surfaces
Disinfection efficacy studies play a significant role in the Pharmaceutical manufacturing environment in ensuring that the surfaces...
Biocompatibility as a Critical Design Input
For any medical device contacting a patient, a biocompatibility evaluation is required before the device can be...
What’s New with Reprocessing Validations for Reusable Medical Devices?
There have been many great strides surrounding the guidance for reprocessing (cleaning, disinfection, and/or sterilization) validations for...
Advancing Microbial-Contamination Detection Through Rapid Sterility Testing
Increasing industry and product demand for expedited product release reinforces the need to embrace rapid sterility technologies....