Foothill Ranch, CA
ACTA runs in-vitro biocompatibility, bioburden, bacterial endotoxin, and chemical characterization testing for medical devices, in-house and under cGMP. Send us a specific device material and a scientist scopes the work. Device testing is a different world than drug testing, so this page covers what ACTA genuinely runs for device makers.
ACTA does not perform in-vivo biocompatibility, and we do not run device sterility. What our microbiology laboratory does run for device makers, in-house and under cGMP, is in-vitro biocompatibility, bioburden, and bacterial endotoxin. Each result comes back as a concise cGMP Certificate of Analysis.
USP <87> Biological Reactivity Tests, In Vitro by Agar Diffusion and Elution. ISO 10993-5 in-vitro cytotoxicity by Agar Diffusion and MTT. Run on device materials and their extracts.
View biocompatibility →USP <85> Bacterial Endotoxins Test by LAL for devices that contact blood, cerebrospinal fluid, and internal tissue, with device endotoxin context under USP <161>.
View endotoxin testing →Extractables and leachables and chemical characterization are sometimes required alongside biocompatibility. Contact us to confirm whether your specific device study falls within ACTA's current scope.
Ask about scope →The large device houses bid on full ISO 10993 programs and can take weeks just to open a small account. If you need cytotoxicity on one material, or endotoxin on one lot, 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.
