Subvisible particles are a specified class of contaminant that can represent a serious health hazard in injectable and parenteral products, with the potential to cause blockages and obstructions.

It is a regulatory requirement for pharmaceutical companies to determine the counts of sub-visible particles in their products from a safety, quality and efficacy point of view.

RSSL offers routine testing to support product release and bespoke analysis to help you during product development, re-formulation and problem solving.  Using complimentary techniques we can identify particles to determine the source of high particle counts.

We can support you with:

  • Sub-visible Particle Testing in Injections/Parenterals (USP <788>, Ph. Eur. (2.9.19), JP 6.07) 
    • Method 1 - Light Obscuration Particle Count Test
    • Method 2 - Microscopic Particle Count Test
  • Sub-visible Particle Testing in Ophthalmic Solutions (USP <789>)
    • Method 1 – Light Obscuration Particle Count Test
    • Method 2 – Microscopic Particle Count Test
  • Visible Particle Testing (USP <790>, Ph.Eur (2.9.20), JP 6.06))
  • Design bespoke methods for the analysis of your products and drug production/storage/delivery components and single use systems
  • Assist you with problem solving and identifying the root cause of high particle counts


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