Laboratory Testing Services

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Ph.Eur. 2.9.19, Ph.Eur. Mono. 0008, Ph.Eur. Mono. 0169, USP 788, ISO 21501-3, AAMI TIR42, 1001105, 1001106, 1001107, 1001110, 1001111, 1001124, 1001125, 100405, 100423, 1007023, 1007030, 100706
Cleaning - Sub-visible particles - USP 788, EP 2.9.19 - analysis

Extraction in particle-free water, light obscuration counting
Ph.Eur. 2.9.19, USP 788, ISO 21501-3, AAMI TIR42, 1001108, 1001109, 1001113, 1001116, 1001124, 1001125, 100405, 100421
Chemistry - Sub-visible particles - USP 788, EP 2.9.19 - method validation

Method validation with count standards at 10µm and 25µm
ISO 16232, 1001105, 1001106, 1001107, 1001110, 1001111, 1001125, 100405, 100421, 100423, 1006061, 10062341, 1007023, 1007030, 100706
Chemistry - Morpho-chemical analysis of particles - 1st sample

Particle extraction, SEM imaging + EDX elemental mapping
ISO 16232, 1001105, 1001106, 1001107, 1001110, 1001111, 1001124, 100405, 100421, 100423, 1006061, 10062341, 1007023, 1007030, 100706
Chemistry - Morpho-chemical analysis of particles - additional samples

Additional SEM-EDX analysis on subsequent samples

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