“Beyond 2015 I see an E&L world that is clearly structured in terms of the process of assessing the direct safety impact of packaging systems and which enjoys unprecedented collaboration between material vendors, drug product vendors and regulatory authorities. By 2015, industry-driven organizations such as the PODP, ELSIE, BPSA and others will have completed their missions and will have published not only best demonstrated practice recommendations but also the foundational science upon which recommendations will be based.”
At the same time extractable and leachable science is solidifying, the absolute requirement for E&L assessment will decrease. Dr. Jenke explains further:
“In the past, E&L horror stories have surfaced as “older” existing material formulations have been characterized. As such formulations may have been developed with little or no regard for E&L, it is logical that such horror stories would exist and thus that the regulatory environment would adopt a strategy of “we cannot let that happen again”. However, as the issues related to E&L have been recognized and discussed, it is now the case that (a) new, “low extractables”
“As the foundation of ensuring the safety of packaging is (a) to use safe material and (b) to use materials that are well-characterized, the industry is moving to a place where E&L testing is more a means of confirming the accepted fact that the packaging is intrinsically safe and less a means of minimizing the risk that the packaging might be unsafe. Thus I see that E&L testing will evolve away from the means of identifying, managing and, where necessary, eliminating “bad actor” materials and more towards the means of systematically confirming that materials are as safe as they were intentionally developed to be.”
While assessments into the direct impact leachables have on patient safety will be well-understood and well-managed in 2015, the assessment of secondary interactions will largely continue being a work in progress at this time according to Dr. Jenke.
“Whilst it is well-recognized and well-documented that such secondary interactions exist, the state of the science with respect to understanding, predicting and managing these processes is not at a point where the issue of secondary actions can be effectively managed. For example, while one can confidently predict the direct safety impact of leachable x found in drug product y, it is not possible to predict that leachable x will react with the ingredients in drug product y to either make them (a) subpotent or (b) unsafe. At the current time, such incompatibilities are addressed retroactively based on precedent. In the future, such incompatibilities will proactively be predicted based on sound scientific principles.”
Dr. Dennis Jenke of Baxter Healthcare will be featuring at Pira International’
For more information visit eandl-conference.com or to enquire about the availability of a press pass contact Daniel Trillo, Pira International, +44 (0)1372 802101, daniel.trillo@