Q. You will be discussing “pMDI leachable study using GC-MS and thermal desorption” for your presentation at E&L Europe next month, could you explain in further detail what this entails?
The traditional methods for pMDI leachable studies usually mean freezing an pMDI can below -20C, cutting it open and bubbling the contents through a solvent or directly pumping an asthma inhaler into an instrument or volumetric flask; these options do not allows for automation and each one has analytical trade offs. Thermal desorption with GC-MS offers robust methodology from environmental industries and automation is achievable (requiring some engineering) with current technology. This slide deck will illustrate how we developed the method for volatiles and semi-volatile leachables in Ventolin asthma inhalers and the results of the method validation. We might have a slide about possible automation, pending GSK legal approval.
Q. What changes have you seen in the E&L market in the last 5 years and how does that influence your current strategy?
E&L is becoming visible to regulators, the food industry and the wider pharma industry; it creates opportunities to expand knowledge and understanding, but it increases the regulatory burdens. At GSK, we are taking a broader view on packaging lifecycle and investing in internal and external resources to meet the changing regulations.
Q. Where do you foresee the industry headed in the next 5 years and why?
USP 661 will have a massive change to E&L and will likely require pharma and packaging manufacturers reconsider current practices. I think the fallout from USP 661 implementation will change the industry.
Q. What are you most looking forward to at E&L Europe 2018?
Technical discussions and innovations in the field.
Are you interested in hearing more about the pMDI study? Book your ticket to join us at Extractables and Leachables Europe this November and hear directly from Rick during his presentation as part of the Case Studies and Analytical Challenges session.