Ireland – Machines and apparatus for testing and measuring – High-Resolution Particle and Cell Sizing, Counting and Distribution Device

The system must be a benchtop instrument able to measure particles concentration and size profile in biological and other liquid samples as small as 200 nm without additional processing (i.e. operate using the coulter principle or equivalent and be able to measure large protein aggregates, blood platelets and characterise mammalian cells or spheroids without the need of using nucleus staining). It must deliver accurate, reproducible size and concentration measurements across 0.2–1,600 μm in samples of 10-2000 µL, support volumetric flow mode, data reprocessing and ISO 9276-1 reporting. The instrument must feature user-friendly software, mercury-free metering, robust quality control, and be EU Annex 11 of the Good Manufacturing Practice (GMP) Guideline compliant and or FDA 21 CFR Part 11 compliant.