Identifying and Mitigating Errors in Organic Extractables & Leachables Screening
We are happy to announce Nelson Labs will be exhibiting in booth #1330 with our sister company Sterigenics at the 2020 CPhI North America trade show, in Philadelphia,Pennsylvania, May 5-7, 2020.
Nelson Labs will have consultants available to CPhI NA participants to answer even the most difficult testing and compliance questions. Stop by booth #1330 for a complimentary personalized 30 minute consultation, and mark your calendar for Nelson Labs’ educational lectures, and roundtable debate (additional details provided below).
Nelson Laboratories’ CphI NA Events:
Topic: Identifying and Mitigating Errors in Organic Extractables & Leachables Screening
Date: Wednesday, May 6th
Presenter: Piet Christiaens, Scientific Director – Nelson Labs Europe
Organic Chromatographic “Screening” to discover, identify and quantify organic compounds in an extract or drug product is a relatively new concept to both the Pharmaceutical and Medical Device Industries. While the Chromatographic Screening process is the best solution to cover the three functions is should serve, each function of the screening process is prone to errors that are inherent to the screening methodology.
- The risk of omission: omitting a compound in chromatographic screening as fatal error
- The risk of inexact identification: mis-identifying a compound as fatal error
- The risk of inaccurate and imprecise quantitation in chromatographic screening processes.
The presentation will explain these errors in detail and how to minimize the occurrence of these errors
Piet Christiaens received his Ph.D. from the Analytical Chemistry Department of the University of Leuven (Belgium) in 1991. From 1992 to 1997, he was Lab Manager in two Analytical Contract Laboratories. From 1997 to 2000, he worked as an independent consultant with Shell Chemical Company in Houston, TX (US) where he conducted research on a new hydrogenation catalyst system for Hydrogenated Triblock Co-polymers (Kraton Polymers). From 2001 onwards, Mr. Christiaens held the position of Scientific Director with Toxikon Europe where he developed analytical methods and protocols for both extractables and leachables studies for the Medical and Pharmaceutical Industries. In his current role at Nelson Labs Europe, Mr. Christiaens supports the Strategy and Global Business Development for Extractables and Leachables Service Offerings for Pharmaceutical and Medical Applications.