The globally recognised accreditation, together with Fairfield’s extensive experience as a GMP FDA-approved laboratory, allows SGS to clearly demonstrate the reliability of its drug development testing results, as well as the integrity, competence and overall quality of the Fairfield laboratory’s practices.
A highly respected quality certification
ISO/IEC 17025:2017 is a globally recognised quality management standard for testing and calibration laboratories.
ISO 17025 certifies technical competence in lab testing and calibration services.
The accreditation covers a wide range of chemical testing and in vitro cytotoxicity (IVT) testing for finished medical devices, medical device components, drugs and packaging. The chemical testing includes a wide range of tests, including
- 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>.
“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 recognised 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.”
