Pacific BioLabs
Hercules, CA, US
Scope
CHEMICAL Test(s): Test Method(s): Chemical Conductivity USP <645> Total Organic Carbon USP <643> Extractable Leachable Testing ISO 10993-18
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ISO/IEC 17025 directory
USP 643 Accredited Testing Labs in United States
8 laboratories in United States are accredited by A2LA under ISO/IEC 17025 to perform USP 643 testing. From the accredited scope text: “USP 643 Viscosity ASTM D445 Powder Characterization Laser Light Diffraction (Microtrac) - Particle Size ASTM B821, B822, C1070 Sieve Analysis - Particle Size ASTM B214, D1214 Hall Flow Rate / Apparent” “USP 643 Determination of Volatile Extractables in Medical Devices by HS-GC/MS ISO 10993-18 1 Assessment to the U.S. FDA GLP (21 CFR 58) Regulations does not imply acceptance by the FDA.” “USP 643 Wet Chemistry pH ASTM D1293 (Method B), E70 ICP – Inductively Coupled Plasma CLP-017; ASTM E3061, E2371, E2594, D1976 Ion Chromatography ASTM D4327 XRD ISO 13779-3; CLP-056 X-Ray Fluorescence”
- Labs
- 8
- Primary AB
- A2LA8 labs
Accredited Labs
STERIS Laboratories, Inc.
Brooklyn Park, MN, US
Scope
Test Method(s) Laboratory Procedure Sterility Testing: Bacteriostasis/ Fungistasis Testing AAMI/ANSI/ISO 11737-2/ USP <71> Q08-WI-001728 Sterility Test Procedure AAMI/ANSI/ISO 11737-2/ USP <71> Q08-WI-001720 Bioburden T
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TUV SUD America
Alpharetta, GA, US
Scope
USP 643 Determination of Volatile Extractables in Medical Devices by HS-GC/MS ISO 10993-18 1 Assessment to the U.S. FDA GLP (21 CFR 58) Regulations does not imply acceptance by the FDA.
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NORTH AMERICAN SCIENCE ASSOCIATES, LLC (NAMSA)
Mendota Heights, MN, US
Scope
SCOPE OF ACCREDITATION TO ISO/IEC 17025:20171 NORTH AMERICAN SCIENCE ASSOCIATES, LLC (NAMSA) 1265 Kennestone Circle Marietta, GA 30066 Heather Laird Phone: 888-847-6633 CHEMICAL Valid To: January 31, 2027
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IMR Test
Lansing, NY, US
Scope
USP 643 Viscosity ASTM D445 Powder Characterization Laser Light Diffraction (Microtrac) - Particle Size ASTM B821, B822, C1070 Sieve Analysis - Particle Size ASTM B214, D1214 Hall Flow Rate / Apparent Density ASTM B212, B213
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U.S. Micro-Solutions
Latrobe, PA, US
Scope
Test(s) Analyte(s) Method(s) Direct Microscope Examination (DME) Microscopic Examination of Fungal Spores, Fungal Structures, Hyphae, Pollen, Insect Fragments, and Fibrous Material from Surface Samples ASTM D7658-17 MIC 02 Mycobacter
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IMR Test Labs - Louisville
Louisville, KY, US
Scope
USP 643 Wet Chemistry pH ASTM D1293 (Method B), E70 ICP – Inductively Coupled Plasma CLP-017; ASTM E3061, E2371, E2594, D1976 Ion Chromatography ASTM D4327 XRD ISO 13779-3; CLP-056 X-Ray Fluorescence (XRF) Posi
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Eurofins SF Analytical - GMP Microbiology
Horsham, PA, US
Scope
SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 EUROFINS SF ANALYTICAL – GMP MICROBIOLOGY 215 Witmer Road Horsham, PA 19044 Maureen Dougherty Phone: (267) 282-2100 BIOLOGICAL Valid To: March 31, 2027
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This page is a fixed slice of the register: every USP 643 scope we hold for United States. Search narrows it further by city, accreditation body, or a term from the scope text itself.
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Top analytes for USP 643 in United States
- Bacteriostasis1
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About ISO/IEC 17025 in United States
American Association for Laboratory Accreditation (A2LA) is the primary accreditation body issuing ISO/IEC 17025 accreditation for testing laboratories in United States.
ISO/IEC 17025 is the international standard for the competence of testing and calibration laboratories. Accreditation to this standard provides independent confirmation that a laboratory operates a quality management system and is technically competent to produce valid results within its declared scope.
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