Join our training course: Extractables/Leachables for Parenteral Applications Training Course (PDA 577)
Date & Time: 14 – 15 May 2026
Location: 4350 East West Highway, Suite 110 Bethesda, MD 20814 USA
Presenter & Trainer: Piet Christiaens, PhD, Scientific Director, Nelson Labs
OVERVIEW
When making parenteral drug products, pharmaceutical companies are faced with the regulatory requirements to further investigate the materials that will be in contact with the drug product either during manufacturing, intermediate storage, storage in its final packaging, or during the delivery of the drug to the patient. While historically, the potential safety issues were the main driver in these kinds of investigations, recently, quality issues, i.e. for biopharmaceuticals, have become an additional concern.
This training course will look at Extractables and Leachables (E/L) from many different angles:
- Regulatory Requirements and Guidelines eg. USP <1663> (Extractables Testing), USP <1664> (Leachables Testing), USP <661> (Plastic Packaging Systems), USP<665> versus BPOG (for Single Uses Systems)
- Material & Polymer Science, the Composition of Polymers
- Mechanisms of Leaching and Material-Drug Product Interaction
- Analytical E/L Methodologies, Strengths and Limitations
- E/L Study Design for Different Packaging Systems
- (Bio)Manufacturing Equipment: Implementing USP<665> and USP<1665>
- Large Volume Parenterals and Simulation Studies
- The specific E/L concerns for Lyophilized Drug Products
- Combination Products and their Specific E/L-Considerations
Several interesting case studies on the above topics will also be presented.
Download the full agenda here: AGENDA
LEARNING OBJECTIVES
Upon completion of this event, the attendee will be able to:
- Identify which regulations are to be followed and what is applicable
- Recognize the impact of the physicochemical properties of a polymers and their impact on the leachable mechanism
- Identify which analytical techniques are necessary in a comprehensive E/L program and what they should accomplish
- Assess the results of an E/L program from a safety perspective
- Design an E/L study that is compliant with the regulatory requirements, by choosing the right set of testing conditions
WHO SHOULD ATTEND
This event is intended for professionals who are involved in sterile drug manufacturing.
Register for the training course HERE.
Piet Christiaens, PhD, Scientific Director, Nelson Labs
Biography
Piet Christiaens received his PhD. 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, Dr. Christiaens holds the position of Scientific Director at Nelson Labs (formerly Toxikon Europe) where he developed analytical methods and protocols for both extractables and leachables studies for the Medical and Pharmaceutical Industries. In addition, he is also leading the R&D department at Nelson Labs, with a focus on understanding the interactions and chemistry of extractables and leachables and developing state-of-the-art analytical methodologies. In the last decade, Dr. Christiaens has been a speaker on the subject of “extractables and leachables” at over 150 Conferences, and since 2014, he has been engaged in the two-day Extractables and Leachables training courses that are hosted by PDA across the Globe. In his current role at Nelson Labs Europe, Dr. Christiaens supports the Strategy and Global Business Development for Extractables and Leachables Service Offerings for Pharmaceutical and Medical Applications.
