SGS, a leading bio/pharmaceutical analytical and bioanalytical contract solutions provider, has significantly increased its capabilities to undertake extractables and leachables (E&L) testing at its Shanghai, China, laboratory
Its investment includes the installation of multiple analytical instruments, including an isothermal static headspace gas chromatograph with flame ionisation detector (HS-GC/MS-FID), two liquid chromatography–mass spectrometers (LC-MS) and one system.
A liquid chromatography with time of flight mass spectrometer (LC-TOF-MS) has also been acquired, along with two inductively coupled plasma mass spectrometers (ICP-MS) and one inductively coupled plasma optical emission spectrometer (ICP-OES).
All instruments have undergone installation and validation and are fully 21 CFR part 11 compliant to ensure integrity of information for regulatory submissions.
In June 2016, SGS announced that it had expanded the laboratory in Shanghai and invested in instruments to undertake comprehensive drug compatibility study testing at the facility and to evaluate E&L contamination.
This additional investment allows SGS to increase its capacity to handle E&L projects for applications including container testing, medical device evaluation and testing equipment used in pharmaceutical production.
“Extractables and leachables testing continues to be a much sought after service by the pharmaceutical industry, and SGS is renowned around the world for its expertise and experience in this area,” commented Andy Yi, General Manager, SGS Life Sciences, China.
“This continued investment in the facilities in Shanghai doubles our capacity in the E&L field, and is in response to the rapid increase in demand from our clients, for whom regulatory compliance is paramount and who trust SGS to overcome analytical challenges effectively and efficiently.”
The investment in Shanghai is the latest undertaken by SGS in E&L testing capabilities, which has also seen the opening of a new global Center of Excellence for Extractable Studies and Impurities Profiling in Wiesbaden, Germany, and the expansion of services offered at its Fairfield (NJ, USA) laboratory.
With 21 laboratories offering contract analytical and bioanalytical services, SGS leverages its wholly owned global network, present in North America, Europe, and Asia, to deliver harmonised solutions to large pharmaceutical and biotechnology firms.
In addition to testing services for the bio/pharmaceutical market, SGS also provides Phase I-IV clinical trial management, and services encompassing data management and statistics, PK/PD modelling and simulation, pharmacovigilance and regulatory consultancy.