Container Closure Integrity and Stability Testing for Rigid Containers
Setting up a stability test plan for vial products can be a daunting task with many variables...
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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...
Effective Auditing for Manufacturing Quality
Gain confidence that your product meets the necessary quality standards and ensure compliance with the guidance of...
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The New FDA Draft Guidance for Biocompatibility of Certain Devices in Contact with Intact Skin: The Naughty and Nice list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...
Why is the Sterility of your Drug Product much more than just a Test of Sterility?
Ensuring sterility and sterility assurance is crucial in the pharmaceutical industry, as the lack of these can...