Validating, Optimizing and Monitoring EO Sterilization Processes – Part 1
Establishing an EO (ethylene oxide) sterilization process can be a complicated path as multiple factors play a...
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Future Trends To Control Risks From Extractables and Leachables
Prior to 2018, ophthalmic drug products (ODPs) and parenteral drug products (PDPs) underwent similar processes for Extractables...
The New FDA Draft Guidance for Biocompatibility of Certain Devices in Contact with Intact Skin: The Naughty and Nice list
When selecting and qualifying the primary packaging for lyophilized drug products, an essential question arises: How comprehensive...
A Delay in MDR? Where are we now?
With the onset of the COVID-19 crisis, the implementation of the Medical Device Regulations (MDR) has been...
Cleaning Validations for Reusable Devices A Road Trip to the EU and US Market
Reprocessing validations for reusable medical devices have often been neglected, but recent regulatory developments have brought their...
An Outline of Current Medical Face Mask Performance Requirements and Testing
The current pandemic has brought medical face masks and respirators into the spotlight, highlighting the critical need...
Recent FDA biocompatibility feedback from 510k submissions
Navigating the FDA approval process for a medical device can be a daunting and stressful experience for...
The Necessity of Extractable and Leachable Qualifications for Lyophilized Drug Products: Some Fallacies Addressed
Lyophilized drug products, also known as freeze-dried pharmaceuticals, require specialized containers and administration devices to ensure their...
Changing Regulatory Requirements for Extractables & Leachables Testing on Pharmaceutical Packaging Systems
Over the past few decades, the scrutiny applied by EMEA and FDA regulators to extractables and leachables...
Shifting Requirements Within the FDA: Expectations in Chemistry Study Design
The FDA’s expectations regarding the design of chemistry studies in support of medical device toxicology have been...