White Paper: Sub-Visible Particles in Sterile Medicinal Products
Published: November 2022
Abstract:
Visible and sub-visible particles can form in prefilled drug delivery systems such as parenteral products during the manufacture, storage, or transportation processes. These particles can have an impact on the drug’s effectiveness and may result in unwanted immunogenic reactions.
This white paper explores the following key topics in visible and sub-visible particles:
- Do Liquid, Sterile Medicinal Products Have to Be Particle-Free?
- What Are Visible and Sub-Visible Particles?
- The Origin of Visible and Sub-Visible Particles
- Methods Of Analysis for Sub-Visible Particles
- USP Limits for Sub-Visible Particles
- Key Innovative Technology to Detect and Characterize Sub-Visible Particles
- Regulatory Overview on Sub-Visible Particles
Keywords: sterile, particles, biotech, manufacturing, contamination control, GMP, quality control, sub-visible particles, visible particles, drug delivery, sterile medicinal products, parenteral products, extrinsic particles, intrinsic particles, inherent particles, protein therapeutics, light obscuration particle count test and a microscopic particle count test, FDA, Health Canada, EMA
Click here to view White paper: Sub-Visible Particles in Sterile Medicinal Products