Sean Fenske, Editor-in-Chief03.11.24
SGS’ Fairfield, N.J., laboratory has earned its ISO/IEC 17025:2017 certification, which certifies technical competence in lab testing and calibration services. The location provides a wide range of chemical testing and in vitro cytotoxicity (IVT) testing for finished medical devices, medical device components, drugs, and packaging.
“This certification is a testament to the expertise, attention to detail, and dedicated support that our Fairfield laboratory offers SGS customers every day,” said Dr. Niveen Mulholland, vice president, Life Science North America at SGS. “We’re delighted to see their outstanding work recognized in this way. This third-party accreditation provides customers with a level of comfort that certified laboratories produce the highest level of accurate and reliable results.”
Among the facility’s test capabilities are:
All of these tests are assessed per ISO 10993-18 and ISO 10993-12, except for the IVT test which is performed per ISO 10993-5 and USP <87>.
“This certification is a testament to the expertise, attention to detail, and dedicated support that our Fairfield laboratory offers SGS customers every day,” said Dr. Niveen Mulholland, vice president, Life Science North America at SGS. “We’re delighted to see their outstanding work recognized in this way. This third-party accreditation provides customers with a level of comfort that certified laboratories produce the highest level of accurate and reliable results.”
Among the facility’s test capabilities are:
- Extractables and Leachables (E&L)
- Analysis of medical devices through Non-Volatile Residue (NVR) analysis
- Liquid chromatography (LC-MS/UV), headspace (HS) or direct-injection gas chromatography (GC-FID/MS) and inductively coupled plasma mass spectrometry (ICPMS)
All of these tests are assessed per ISO 10993-18 and ISO 10993-12, except for the IVT test which is performed per ISO 10993-5 and USP <87>.