Foothill Ranch, CA
ACTA runs the USP <85> Bacterial Endotoxins Test under cGMP on water for injection, water systems, parenteral products, and medical devices. Send us a specific material and a microbiologist scopes the work.
ACTA performs the USP <85> Bacterial Endotoxins Test under cGMP. Endotoxin testing applies to water for injection, parenteral drugs, and medical devices that contact blood, cerebrospinal fluid, and other internal tissues. ACTA also tests water systems and supports device endotoxin testing under USP <161>.
Our microbiology laboratory runs this work in-house. You receive a cGMP Certificate of Analysis (COA) for release or submission.
Bacterial endotoxins are fragments of the outer membrane of gram-negative bacteria. They can cause a fever response even after the bacteria are gone, so any product that enters the bloodstream must be shown to be below its endotoxin limit.
The USP <85> test uses Limulus Amebocyte Lysate, a reagent that reacts in the presence of endotoxin. The result is reported in endotoxin units per milliliter and compared against the product’s limit.
Endotoxin testing applies to water for injection, parenteral drugs, and medical devices that contact blood or cerebrospinal fluid.
The sample is combined with LAL reagent. Endotoxin drives the reaction, the signal is read, and the result in EU per mL is compared against the product limit. Hover any stage to see what it does.
The large labs route a single endotoxin project into a queue that can take a month to start. ACTA takes the one material, scopes it with a microbiologist, and follows up. Many of our largest accounts started as one small test.
Compendial and custom methods across instruments.
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Separation of volatile compounds by GC (FID, TCD, MS).
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USP <232> / <233> elemental impurities by ICP-MS.
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TOC, conductivity, and endotoxin for water systems.
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cGMP storage with scheduled, monitored pull testing.
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Method development and validation to USP and ICH.
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