We are happy to announce we will be exhibiting at E&L Conference 17 – 18 November in Brussels.
Our Scientific Director, Piet Christiaens, will be presenting there:
The Necessity of Extractable & Leachable Qualifications for Lyophilized Drug Products: Some Fallacies Addressed.
Presenter: Piet Christiaens Phd, Scientific Director
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: www.eandl-conference.com