Understanding FDA Guidance of Particle Testing and Method Impact for NovaPure® 

Duration: 1 hour

The presence of visible particulate in a parenteral product has the potential to cause patient harm. It is for that reason that parenteral products must be essentially free of visible particles but achieving that goal can be challenging for drug manufacturers. Particles can be introduced to the product throughout the manufacturing process and can originate from extrinsic, intrinsic or inherent sources. The FDA is in the process of publishing a guidance “Inspection of Injectable Products for Visible Particulates” which focuses on a holistic risk-based approach for controlling the presence of visible particles beyond establishing a visual inspection program.

This webinar will review the details of the draft guidance including the importance of component selection as it relates to establishing a risk-based approach. We’ll examine the role of the NovaPure® product line in component selection and the importance of applying an appropriate test method for particle analysis of components. The newly published TR-85 “Enhanced Test Methods for Visible Particle Detection and Enumeration on Elastomeric Closures and Glass Containers” will also be discussed. Key takeaways will include:

  • Why are particles important to control
  • Understand new FDA guidance
  • NovaPure® product line and how particles are controlled Information Classification: General
  • What is the process for determining right method; not all methods are the same 


John Rech
Technology Manager for Particle Analysis
West Pharmaceutical Services

Ravi Patel
Director, Quality Engineering
West Pharmaceutical Services


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