Extractable and Leachables Team continues to expand in both capacity and capabilities

Thomas Lehman, PhD, Director, Method Development and Validation and Extractables and Leachables, Eurofins Lancaster Laboratories, ThomasLehman@eurofinsUS.com

Eurofins Lancaster Laboratories, Inc. continues to increase its Extractables and Leachables testing capacity and capabilities with the addition of accurate-mass quadrupole time-of-flight mass spectrometry (QTOF) capabilities, and the establishment of a testing regimen that meets the requirements of the BioPhorum Operations Group (BPOG), an industry-formed working group.

QTOF provides a third accurate mass liquid chromatography mass spectrometer dedicated to extractables and leachables testing. QTOF, coupled with an ultra-high pressure liquid chromatograph, provides high resolution accurate mass data for both parent and daughter ions. When this data is combined with our proprietary database of over 1,300 compounds commonly utilised in the manufacture of plastics and polymers, it provides improved ability to identify unknown compounds observed during an extractables study. The system is equipped with a multi-mode source, allowing for both chemical and electrospray ionisation in a single run.

BPOG has published a guidance document providing a standardised extractables testing protocol focused on single-use systems. The guidance document provides information on appropriate sample preparation, extraction conditions (including extraction time and temperature and extraction solvents) and analytical methods that should be utilised in analysing the resultant extracts. Eurofins Lancaster Laboratories has purchased additional equipment (including incubating platform shakers) to support performing the single-use system extraction as per the BPOG protocol. In addition, previously established Eurofins Lancaster Laboratories analytical methodologies are in line with the methodology recommended in the guidance document.

Eurofins has sites in the US and the EU that can assist with E&L needs. All sites combined performed over 300 controlled extraction studies last year and can design an extractables study to meet clients’ project needs. Whether the study will be performed on a container closure system, single-use system, or medical device, Eurofins has experience in designing and performing studies based on guidance from the Product Quality Research Institute (PQRI), the Bio-Process Systems Alliance (BPSA) or BPOG.