Comprehensive PFAS screening in pharmaceutical packaging and medical devices

Per- and polyfluoroalkyl substances (PFAS) are persistent in the environment and human body, posing potential health risks. Regulatory agencies like the FDA and EPA have set strict guidelines for PFAS in environmental samples, however, there are no regulatory guidelines for PFAS levels in pharmaceutical products and medical devices, which could affect their safety and efficacy.

Companies should stay informed on regulations and develop risk mitigation strategies to avoid product recalls or approval delays. We present an LC-MS based analytical strategy to detect and quantify PFAS in pharmaceutical test materials, demonstrated on fluorine-containing polymer components with SGS Health Science.

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Presenter: Chongming Liu, PhD. (Supervisor - E&L, SGS Health Science)

Dr. Chongming Liu serves as a Supervisor in the Extractables and Leachables (E&L) team at SGS Health Science in Fairfield, NJ. At SGS, his daily responsibility is to oversee the team members in performing E&L testing on pharmaceutical containers and medical devices, serve as a technical expert in resolving analytical challenges, assist laboratory maintenance as well as instrument troubleshooting, and to elucidate structures for unknown organic compounds of interest based on high-resolution GC-FID/MS and LC-PDA/MS data. Prior to his current role, Chongming joined the E&L team at SGS as an Instrumentation Chemist, and obtained experience in hands-on analytical techniques, study design and technical writing. During his graduate study, Chongming got the opportunity to immerse into extensive training in modern mass spectrometric techniques and obtained a Ph.D. degree in Analytical Chemistry from Stevens Institute of Technology. Prior to that, he held a B.Sc. degree in Chemistry from University of Science and Technology of China (USTC).

Presenter: Maciej Bromirski (Sr. Product Marketing Manager, Thermo Fisher Scientific)

Maciej Bromirski has over 25 years of experience in mass spectrometry starting as an undergraduate student with late Prof. Ken Standing at the Physics Department at University of Manitoba in Winnipeg, Canada. Upon completion of his graduate studies on IR & UV vacuum MALDI Q-TOF prototype MS with first oral presentation at ASMS and publications starting in 1999, Maciej undertook various roles and responsibilities with different Mass Spectrometry vendors. Since 2010 to present-day, Maciej has been fully dedicated to new product introductions and marketing developments of Q Exactive series and Orbitrap Exploris series MS with Thermo Fisher Scientific. His dedication to Thermo Fisher Scientific continues with completion of Executive Master of Business Administration in 2021 during full time employment.

Presenter: Jon Bardsley (Market Development Manager Pharma & Biopharma, Thermo Fisher Scientific)