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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