Q. Your background in E&Ls stretches far, could you summarise how you came to be involved in E&L research and why you think interest in E&Ls is becoming more and more prevalent among the pharma industry?
"I sell both stainless steel and polymer equipment and noticed that working with polymeric equipment necessitates detailed knowledge of polymers and how they function (or don't function!) with regarding to their use in bioprocessing equipment- this is what initiated my tremendous research in the field of E&L. Over the years, interest in E&L has grown since the more something is being used, the more people are interested in it functioning properly."
Q. You chaired the E&L task group in the BPE Polymeric Subcommittee for 5 and half years, what were the main tasks that you made progress on during this time?
"We described why E&L testing is done, we created standard definitions for E&L, and we prepared some basic sample preparation and risk analysis recommendations. Most importantly, we made progress on communication and education regarding this extensive topic of E&L. In a room full of suppliers, chemical engineers, end-users, all or mostly all have knowledge in polymers but often vary in best practices, it was important that we learned from each other and I helped navigate this quest."
Q. What was your most recent achievement in terms of progressing E&L research and knowledge?
"One most recent achievement is the preparation of recommendations when attempting to formulate an extractable study. This was highly complicated as there are no standard recommendations for every application due to the presence of multiple variables within every process but we tried to give some basic recommendations that we feel could be useful in some applications."
Q. Is there anything in particular that you hope they make progress on in the next 5 years?
"I am the vice chair of the BPE Polymeric Subcommittee so my job is to oversee all of the taskgroups, including E&L and to help in any way I can. The new Chair is highly qualified and I am looking forward to their progress in areas needed most by the industry; time and discussion will define what those areas are."
Q. Do you think there is currently enough sharing of knowledge in the E&L field?
"I think fears exist with the sharing of knowledge. Some of those fears are created when single-use suppliers are being put on the defensive; I think more sharing would take place if the right questions and concerns were put forth properly. I also think the suppliers, on their part, should provide materials they have sufficient confidence in, regardless of any E&L tests that might be suggested (although they can still oppose tests due to costs). That being said, some knowledge is proprietary and might require a NDS to allay fears if companies are concerned."
Q. You were also a speaker at the E&L Europe conference, what did you gain from the European event?
"Besides seeing a beautiful area of London I hadn't seen previously, I gained in three other ways (if not more). I learned some commonalities amongst the practices of E&L testing throughout the life of the product, either early in the process, during manufacturing, or with the final product and packaging. I also learned, hearing it various times throughout the conference, that a lot depends on the application and coming up with standard requirements for E&L testing could be a challenge. Most importantly, I learned how much E&L has gained major interest among so many organizations and how we are all extensively working alone and together to help the industry in whatever way we can."
Q. What are you hoping to achieve from your presentation at E&L USA this year?
"I hope to go into specific obstacles that arise regarding progress in this topic and give clear cut recommendations that I feel would assist the people who intend on publishing content on E&L, as well as companies intending on using polymeric equipment."