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Irvine Medical Products Laboratory (IRVLMP)

Program Capabilities

The Irvine Medical Products Laboratory (IRVLMP) is an ISO/IEC 17025-accredited multi-disciplined drug based testing laboratory. The laboratory has a chemistry and microbiology section, each capable of testing for a wide range of chemical analytes and pathogenic/non-pathogenic microorganisms, respectively. In addition to the scientific analyses performed by the IRVLMP Laboratory, the laboratory staff also support domestic and foreign pre-approval, surveillance, and for-cause inspections. IRVLMP has both Chemistry and Microbiology capabilities.

Chemistry

Medical-product chemical analysis capabilities include active pharmaceutical ingredient identity, potency, content uniformity, impurity and dissolution testing; rapid and high-throughput testing for targeted adulteration such as diethylene glycol in toothpaste, active pharmaceutical ingredients in dietary supplements, and herbal products and toxic substances in botanical constituents.

Microbiology

IRVLMP’s microbiology analysis capabilities include performing specialized testing of medical products according to USP compendial methods. Routinely performed analyses include sterility testing using isolator technology, endotoxin assays, microbiological analyses of non-sterile products, subvisible particle analysis, and antimicrobial effectiveness testing. In addition, IRVLMP has advanced identification instruments for DNA sequencing of bacterial and fungal isolates.

Specialized Capabilities

Using novel applications and techniques and specialized instrumentation including ICP/MS Triple Quad, LC/MS Triple Quad, LC/MS QTOF, GC/MS Triple Quad, GC/MS QTOF, and supercritical fluid chromatography, IRVLMP performs investigative research, analytical method development and validation, and specialized testing. IRVLMP also performs surgical glove and condom integrity testing.

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