Foothill Ranch, CA
ACTA runs USP <87> Biological Reactivity Tests, In Vitro and ISO 10993-5 in-vitro cytotoxicity under cGMP, on medical device materials and their extracts. Send us a specific material and a scientist scopes the work.
ACTA performs USP <87> Biological Reactivity Tests, In Vitro and ISO 10993-5 in-vitro cytotoxicity under cGMP. These tests screen medical device materials and their extracts for a cytotoxic response, run in our microbiology laboratory in-house. Each result comes back as a concise cGMP Certificate of Analysis (COA).
In-vitro cytotoxicity testing exposes cultured mammalian cells to the device material or an extract of it, then looks for a toxic response. The ISO 10993-5 standard uses the L929 mouse fibroblast cell line. USP <87> grades the biological reactivity of the cells on a scale from Grade 0, no reactivity, to Grade 4, severe reactivity.
Each method runs against positive and negative controls. A material passes when its reactivity is not greater than Grade 2 by USP <87> or ISO 10993-5. The USP and ISO criteria are harmonized. The result is reported on a cGMP Certificate of Analysis.
The material or its extract is prepared, L929 cells are seeded, the cells are exposed by agar diffusion or elution, the response is graded from Grade 0 to Grade 4, and the result is reported on a cGMP COA. Hover any stage to see what it does.
The large device houses bid on full ISO 10993 programs and can take weeks just to open a small account. If you need in-vitro cytotoxicity on one material or extract, ACTA scopes that specific test, quotes it, and a scientist follows up. Many of our accounts started as a single test and grew from there.
What ACTA genuinely runs for device makers, in-house and under cGMP.
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USP <85> endotoxin by LAL for devices and parenterals.
View →cGMP microbiological testing across USP chapters.
View →USP <61> / <62> enumeration and specified organisms.
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