CPHI Webinar Series

The Necessity of Extractables & Leachables Qualifications for Lyophilized Drug Products

15 December, 2021
4pm CET / 10am EST
What will this webinar address?

When selecting and qualifying the Primary Packaging for lyophilized drug products, one of the obvious questions is “how deep should one go into the E/L-qualification process of a lyo-container”. As the drug product is in a solid state, it is expected that the interaction between the lyophilized drug product and the components of a lyo-container will be low. This is also reflected in the USP<1664> Monograph on Leachables and the EMA Guideline on “Plastic Immediate Packaging Materials” (2005). However, the mechanism of interaction between the lyo-cake and e.g. the rubber stopper (when considering a lyo vial) are not always fully understood. The interaction mechanism is based upon “outgassing” of the rubber stopper, where the lyo cake acts as an adsorbent. Not only can this lead to substantial accumulation of the volatile and semi-volatile leachable compounds onto the lyophilized drug product, it may also induce chemical reactions between the leachables and the drug product, i.e. when the adsorbed leachables show electrophilic properties.

When you attend this webinar, you will have:
  • A thorough understanding of the interaction mechanisms between a lyophilized drug product and it's container.
  • An understanding of an Extractables and Leachables study design for a lyophilized drug product
Piet Christiaens PhD
Scientific Director
Nelson Labs NV

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 CROs. From 1997 to 2000, he worked as an independent consultant with Shell Chemical Company in Houston, Texas (US), working on hydrogenated triblock co-polymers.

Since 2001, Piet has held the position of Scientific Director at Nelson Labs Europe where he develops analytical methods and protocols for both extractables and leachables studies for the pharmaceutical and medical industries. Piet oversees all laboratory operations at Nelson Labs Europe and is also giving support to business development and R&D.

This webinar is brought to you by
The Necessity of Extractables & Leachables Qualifications for Lyophilized Drug Products
  • December 15th, 2021
  • 4pm CET / 10am EST
  • 60 minutes
  • Free
CPHI Newsletter

Get the latest from CPHI in your inbox every week.

You understand that your information will be used in accordance with our Privacy Policy, and that you may withdraw your permission to receive any of our communications at any time by clicking on the Unsubscribe link in the Newsletters or opting out on our unsubscribe page page.