Nitto Avecia Pharma Services | Microbiological Testing

Compendial testing

We offer a broad range of cGMP microbiological testing services. Tests are performed according to official compendial methods such as USP, EP, BP, JP, AAMI, ISO standards, and client specific protocols. We test raw materials, in process materials, and finished products.

Product validation

We offer full validation services for compendial methods for your raw materials or finished products:

Microbial limits: Suitability testing by pour plate and membrane filtration
Endotoxin: Inhibition-enhancement testing by Gel-clot, Kinetic Chromogenic, Kinetic Turbidimetric or NextGen Recombinant methods
Sterility: Bacteriostasis/fungistasis testing by direct inoculation, open or closed membrane filtration methods
Compendial method verification and validation services along with full documentation for NDA and IND submissions

Testing in support of CMC

We offer a wide range of testing services:

Sterility, endotoxin, microbial limits test, bioburden, and growth promotion testing
Environmental monitoring
Container closure integrity testing (dye immersion and micro ingression)
Autoclave, depyrogenation oven, and manufacturing equipment qualification
Media fill studies, hold time studies, log reduction studies, BI studies, population and verification studies