Establishing the Proper Alcohol/Water Proportion for Simulating Solvents Used in Controlled Extraction Studies
The purpose of this whitepaper is to provide comprehensive guidance on determining the appropriate alcohol/water proportion for...
Browse Content
How Chemical Characterization Can Supplement and Support Biocompatibility Testing
There’s a lot of urban legend when it comes to using gamma radiation to reduce pathogens in...
Rapid Sterility Testing: A New Solution For Short Shelf Life Products
All drug products must undergo sterility testing to comply with Good Manufacturing Practices (GMP). Parenteral drug products,...
Selecting & Justifying Sample Sizes: Where to Begin?
Within the medical device industry, determining the ideal sample size is crucial for ensuring accurate testing and...
Single Use & Newly Manufactured Device Cleaning Validations
Performing a cleaning validation during the initial phase of a device’s lifecycle is crucial for manufacturers to...
Successful Medical Device Cleaning Validations: What You Need to Know
Validating cleaning instructions for a tray of reusable orthopedic devices is an essential milestone on the path...
The Use and Utility of General Chemistry Data in Extractables Assessment
This whitepaper explores the critical role of general chemistry data obtained in controlled extraction studies, including pH,...
Understanding the EU Medical Device Regulation for Device Companies
The new European Union (EU) Medical Device Regulation (MDR), effective from May 2020, will significantly impact medical...
Use of Accelerated Conditions in Extractables and/or Leachables Studies
The purpose of this whitepaper is to delve into the scientific principles behind establishing accelerated contact conditions...
Use of Exaggerated Surface Area to Solution Volume Ratios in Extractables Studies; Equilibrium Case
The goal of this whitepaper is to provide comprehensive guidance and justify appropriate practices concerning the proper...