USP <788> / <787> and Ph.Eur. 2.9.19 particulate testing
Coriolis Pharma is a dedicated service provider specialized in characterization and quantification of subvisible particles in accordance with USP <788> and USP <787>, as well as Ph.Eur. 2.9.19. (PARTICULATE CONTAMINATION: SUB-VISIBLE PARTICLES, METHOD 1. LIGHT OBSCURATION PARTICLE COUNT TEST)
For testing of protein and other biopharmaceutical products where sample amount is limited low volume light obscuration methods with a sample requirement of less than 1.5 ml are the first choice, as outlined also in our publication ("Pharmaceutical feasibility of sub-visible particle analysis in parenterals with reduced volume light obscuration methods"). Low volume methods are also compatible with USP <787>.
For light obscuration testing in full accordance to USP <787> and to GMP level, Coriolis can offer a method optimization, compendial method verification and subsequent sample analysis package, tailored to our customers' requirements.
At Coriolis Pharma we use the light obscuration system PAMAS SVSS-C, which has a linear range up to 120,000 particles/ml > 1 µm, as opposed to the also widely used HIAC-Royco system, which has a linear range up to only 20,000 particles/ml > 1µm. Our light obscuration services are offered to R&D and GMP level.
As orthogonal method to light obscuration we offer flow imaging microscopy (Micro-Flow Imaging™), to GMP level, which allows further qualitative and quantitative sample analysis, e.g. differentiation of proteinaceous particles from silicone-oil droplets. Additionally, Coulter Counter measurements can be offered as orthogonal, non light-based technique.
In addition to subvisible particulate testing we also provide testing of visible particulates according to Ph.Eur. 2.9.20. PARTICULATE CONTAMINATION: VISIBLE PARTICLES, as well as semi-automated visual inspection. We are equipped to produce time-lapse videos and/or images of visible particles to document particle formation over a certain time span.