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Previous Blogs

Particle Testing
Particle Testing Particulate zero defects
Achieving ″Zero″ Defects for Visible Particles in Injectables

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.

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Survey Responses
Particles Particulate Webinar
Industry Insight – Particles and Sterile Drug Products

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.

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USP Particle Workshop Particulate
USP Particle Workshop – Addressing Issues and Improving Clarity

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.

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