Microtest’s Medical Device, Analytical Capabilities Speed Time to Market for Manufacturers
AGAWAM, MASS. – March 26, 2008 – Microtest’s (www.microtestlabs.com) contract manufacturing and analytical testing capabilities integrate rapid regulatory approvals, testing precision and expertise to speed time to market for medical device manufacturers.
“With the continuing addition of new resources and skilled professionals, and the installation of a MicroSeq® Microbial Identification System, Microtest is expanding its services and position as a leader in the medical device manufacturing market,” said Shawn Sherry, Microtest Project Manager.
Microtest’s enhanced medical device sterility validation and release testing services (www.microtestlabs.com/medical-device-testing) include:
- Gamma/EO Sterilization Validation: Bioburden; Bioburden Recovery; Bacteriostasis/Fungistasis; Sterility; Dose Calculation; Spore Strip Population; Ethylene Oxide Residuals
- Reusables: High/Low Level Disinfection; Cleaning Studies; Steam / EO / Chemical Sterilization
- Endotoxin: FDA / USP Gel Clot; Chromogenic; Turbidimetric
- Sterility: USP; ANSI/AAMI/ISO; Product Immersion; Product Flush; Biological Indicator; Membrane Filtration; Steritest(TM) / Sterisolutest(TM)
Microtest’s upgraded analytical services (www.microtestlabs.com/analytical-chemistry-testing), performed as needed in accordance with USP/ISO/BP/AOAC/AAMI/JP requirements, include:
- Services: ETO, ECH, EGLY Residuals Analysis; ETO, Pilot Vessel Studies; Formaldehyde Residuals Analysis
- Water Testing: TOC (Total Organic Carbon); pH and Conductivity; Total Chlorine; Total Nitrates and Heavy Metals
- Wet Chemistry: Heavy Metals; Non-volatile Residues; Residues on Ignition; Direct Titration; Nitrates
For more information on Microtest capabilities and services, visit Microtest in booth #4844 at PharmaMedDevice 2008, March 26-28, 2008 in the Pennsylvania Convention Center in Philadelphia. Or, visit the Microtest website at www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption.
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