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PDA 2022: Parenteral Packaging Conference


June 2, 2022 - June 3, 2022


Basel, Switzerland

Contact Information

Barbara Deckers
+32 16 40 04 84

We are proud to invite you for the 12th Parenteral Packaging Conference to take place in Basel/Switzerland, 02-03 June.

Our expert, Piet Christiaens PhD, Scientific Director at Nelson Labs, will deliver a presentation at this event:

The Necessity of Extractable & Leachable Qualifications for Lyophilized Drug Products: Some Misconceptions Addressed.

Presenter: Piet Christiaens PhD, Scientific Director at Nelson Labs

Friday, 03 June 2022, at 10:30 am CET

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.

Find more information about this event at: https://www.pda.org