Coronavirus & Barrier Material Tests
According to the CDC and OSHA, the minimum recommended protection against possible contact with the coronavirus is...
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How to Evaluate a New Product Against an Existing Product in a Validated EO Process
Section 12 of ISO 11135:2014 provides a pathway for adding new or modified ("candidate") products to an...
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...
When Drug Meets Device
When a medicinal product (drug or biologic) meets a medical device, a combined product is created. Incompatibility...
Why Extractables and Leachables Matter
Medicines and other healthcare products rely on a delicate balance between quality, safety, and efficacy for their...
Considerations for Third-Party Reprocessing of Single-Use Medical Devices
Reusing single-use devices that have been safely reprocessed by a third-party reprocessor offers significant benefits for healthcare...
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...
EO Residue Levels in Medical Devices: Best Practices for Demonstrating Compliance with ISO 10993-7
Sterilizing medical devices via ethylene oxide (EO) gas is an effective and widely used practice within the...
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...
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,...