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Pharmaceutical Manufacturing and Packing Sourcer

Advancing the Detection of E&L by Pharma Manufacturers

Pharmaceutical products encounter a wide range of polymeric materials on their journey from the production line to the patient, with plastic and rubber surfaces present at almost every stage of a product’s lifecycle. While these materials are essential to ensure the sterility and quality of medicines during their manufacture and storage, the leaching of potentially hazardous substances into the products themselves can pose a risk to human health.

Rigorous testing workflows must be employed to make sure these extractable and leachable compounds (E&Ls) are fully understood and do not impact patient safety or pharmacological activity. The need to detect a wide variety of compounds necessitates the application of a range of different analytical techniques and testing protocols, making E&L studies often lengthy and complex.

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About the authors

Xiaoteng Gong received his Master’s degree from the Illinois Institute of Technology, US, and has worked on food contact materials at the National Center for Food Safety and Technology of the FDA. With extensive experience in analytical chemistry, he is currently an instrumentation chemist specialising in E&L study for pharma packaging at SGS. Gong has more than five years of experience using headspace GC. Additionally, he is the project manager directly carrying out the TriPlus 500 GC HS auto-sampler application project.

Dr Dujuan Lu serves as the Manager for the E&L team at the SGS Fairfield facility as well as the global leader among the three centres of excellence for E&L testing. Before joining SGS, she was working at Fresenius Kabi, leading E&L projects to support transfusion and infusion medical device and parenteral products. She has extensive pharma industry experience with more than 300 E&L projects on a broad range of packaging systems, including process materials, pharma finished packaging, and medical device. As a well-recognised E&L subject matter expert in the field, she frequently presents at various conferences as an invited speaker and technical session chair. Dujuan holds her PhD in analytical chemistry from the University of Pittsburgh, US, with more than 10 years of experience in pharma analysis by LC-MS and GC-MS.

Daniela Cavagnino received her Master’s degree in Chemistry at the University of Milan, Italy. She started her career in GC at Thermo Fisher Scientific, spending several years in the R&D laboratories working on GC technology innovation. Then, she conveyed her technical background into product management and marketing management roles with more than 15 years’ experience in promoting GC/GCMS technology and applications in several different market segments. Daniela is currently Product Marketing Manager for GC and sampling solutions, working to increase awareness about new technological advances in GC available to improve productivity and efficiency in modern laboratories.
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