Introduction Developing safe and compliant medical devices, pharmaceuticals, and biologics requires a strong focus on risk management. One of the […]
Custom E&L Study Design and Method Development Read More »
Single-use bioprocessing technologies are changing the way modern biopharmaceuticals are made. They provide flexibility, reduce cleaning requirements, and improve production
E&L Testing for Single-Use Bioprocessing Materials Read More »
Introduction The Analytical Evaluation Threshold in E&L Testing is a key concept that determines whether a detected compound requires further
Analytical Evaluation Threshold (AET): Understanding Its Role Read More »
Introduction A Controlled Extractables Study (CES) is a carefully designed scientific test that checks whether materials release chemical compounds when
Controlled Extractables Study (CES): What, Why, How Read More »
Introduction When organizations ask how to conduct an Extractables and Leachables (E&L) study, the answer lies in following a carefully
How an E&L Study is Conducted: Sample Prep to Risk Assessment Read More »
Introduction The release of the ICH Guideline for E&L Testing (Q3E) marks a big step forward for pharmaceutical and medical
News: ICH Releases New Q3E Guideline on Extractables & Leachables—What You Need to Know Read More »
Introduction In the pharmaceutical and medical device industry, E&L Testing Mass Spectrometry Experts are essential for keeping patients safe, ensuring
Mass Spectrometry Experts on E&L Testing: Ensuring Device and Packaging Safety Read More »
🔍 Summary: Key Takeaways ✅ Introduction Understanding and meeting E&L Regulatory Requirements for Medical Devices is essential for companies aiming
🔍 Summary – Key Takeaways Introduction: Why E&L Testing Matters Extractables and leachables (E&L) testing is critical to confirm the
What Are the Analytical Techniques Used in E&L Testing for Medical Devices? Read More »
✅ Summary – Key Points at a Glance 🔍 Introduction to Extractables vs Leachables in Medical Devices Knowing the difference
Extractables vs. Leachables in Medical Devices: What’s the Real Difference? Read More »
