Laboratory Testing Services

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USP 1057, ISO 15883-1, AAMI ST98, Ph.Eur. 2.5.33, 1001107, 1001108, 1001110, 1001113, 1001116, 100423
Chemistry - Residual Proteins - Method validation

Recovery validation with BSA spike, 3 concentration levels
ISO 15883-1, AAMI ST98, 1001105, 1001106, 1001107, 1001109, 1001111, 1001116, 1001124, 1001125, 100421, 1007023, 1007030, 100706
Chemistry - Residual hemoglobin - analysis

Spectrophotometric detection at 405nm after alkaline extraction
ISO 10993-12, ISO 9377-2, 1001108, 1001109, 1001111, 1001116, 100423
Chemistry - Total Hydrocarbon (THC) - method validation

Recovery validation with hydrocarbon standard, GC-MS method
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
USP 1057, ISO 15883-1, AAMI ST98, Ph.Eur. 2.5.33, 1001105, 1001106, 1001109, 1001110, 1001111, 1001116, 1001124, 1001125, 100421, 1007023, 1007030, 100706
Chemistry - Residual proteins - analysis

BCA assay after extraction in 1% Triton x100 solution
ISO 10993-12, Ph.Eur. 2.2.44, USP 643, EN 1484, 1001105, 1001106, 1001109, 1001113, 1001116, 100423, 1006229
Chemistry - TOC (medical device) - method validation

Recovery study with sucrose spike in extraction water

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