Written by our experts, our blog provides updates on regulatory issues, upcoming changes to compendial test standards, and information about our participation with standard writing committees and organizations (AAMI, ASTM, AATB, ISO).
September 30, 2025
By: Lisa Bonner
In January 2023 the ASTM F23 Biological Committee balloted to revise the Sub-Micron Filtration Efficiency Test Method used in ASTM...
September 29, 2025
By: Jan Baeten
Blog Post 3 – From fill line to fault line: tracing impurities in drug manufacturing 2 min reading time Among...
September 22, 2025
By: Peter Verleyen, PhD
Blog Post 2 – MIND THE LABEL: rapid impurity identification through in-house intelligence 2 min reading time Even subtle changes...
September 15, 2025
By: Ward d'Autry
Blogpost 1 – An unexpected impurity in my drug product, what now? 6-7 min reading time Welcome to the first...
September 3, 2025
By: Christopher Parker, M.S., M.B.A., Thor Rollins and Nicholas Christiano
ISO 10993-1 guides the biological evaluation of medical devices. With the Final Draft International Standard (FDIS) approved, this update is...
