Extractables and Leachables (E&L) studies are needed to identify and quantify any impurities which can contaminate drug products from packaging, equipment or single-use systems.
SGS has purchased and installed two new instruments that are specialised in detecting these kind of contaminants at its Fairfield lab in New Jersey.
These are a liquid chromatography-tandem mass spectrometer (LC-MS-MS) and a gas chromatography-mass spectrometer (GC-MS), which are used to identify traces of unknown extractable compounds.
In addition, the Swiss firm is hiring extra analysts specialising in E&L testing to operate the new equipment and contribute to the expansion of its quality assurance and control services.
“SGS has seen a rise in the demand for services in this area, and we have invested significantly across our global network to ensure that we can maintain our strong reputation for extractables and leachables testing expertise,” said Kelly Bertrand, General Manager of SGS’s Fairfield facility.
SGS claims both of the new instruments have enough space for the user head, high resolution and high throughput systems.
An LC-MS-MS offers superior specificity compared to that of traditional immunoassays and high performance/pressure liquid chromatography (HPLC).
Additionally, the tech has a higher throughput than the GC-MS, requiring a smaller amount of material needed for testing.
The Fairfield lab offers the instruments use for E&L testing of final pharmaceutical packaging, single-use systems and medical devices.
Bertrand added “The additional capabilities we have now at Fairfield allow us to overcome greater analytical challenges for our existing clients, and ensure we can remain competitive and have the capacity to attract new customers.”
SGS employs over 90,000 with 21 labs that provide contract analytical testing services across North America, the EU and Asia.
The firm also provides Phase I-IV clinical trial management, and services encompassing data management and statistics, PK/PD modelling and simulation, pharmacovigilance and regulatory consultancy.
This E&L investment at the Fairfield laboratory follows the opening of a new global Center of Excellence for Extractable Studies and Impurities Profiling in Wiesbaden, Germany.