Previous Blogs

Particle Testing

By Olga Laskina

三月 01, 2019

Injectable drug products have stringent requirements for the presence of visible particles. However, there is currently no regulatory guidance for visible particles related to packaging components. Instead, specifications are established between suppliers and customers.

Survey Responses

By Varun Gupta

一月 25, 2019

West presented a webinar: Navigating Particle Challenges in Sterile Drugs from Component to Patient by Fran DeGrazio, Vice-President, Scientific Affairs & Technical Services, and John Rech, Technology Manager – Particles, Analytical Lab Services, LLC.

By Fran DeGrazio

七月 18, 2017

United States Pharmacopeia (USP) held a two-day workshop, Control and Determination of Visible and Sub-Visible Particulate Matter in Biologics, June 26 & 27 at their Rockville (MD) site. This was the first USP particle workshop in several years; the robust attendance demonstrated that control of particles continues to be a major focus of the pharmaceutical industry.