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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 stability studies, 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.
Method 1 - light obscuration particle count test
Method 2 - microscopic particle count test
This includes biotechnology-derived protein and peptide products (USP<787>)
Small volume method (≥1 mL per sample) USP<787> is an alternative to USP<788> and Ph. Eur. (2.9.19), but as the USP<787> analytical method significantly reduces the total volume of product needed for analysis, it therefore offers all of our clients the flexibility to choose the most appropriate method based on product cost and availability
(USP <790>, Ph.Eur (2.9.20), (JP 6.06))
We can design bespoke methods for the analysis of your products and drug production/storage/delivery components, elastomeric parts and single use systems.
We can assist you with problem solving and identifying the root cause of high particle counts
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