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March / April 2021

ISPE Aseptic Conference Turns 30

ISPE
ISPE Aseptic Conference Turns 30

The ISPE Aseptic Conference will celebrate its 30th year with the virtual conference on 15–17 March. The conference has been setting the pace for the evolution of sterile manufacturing processes and technologies in the pharmaceutical industry. This year’s virtual conference platform is providing a unique opportunity for expanded global participation by speakers and attendees.

Jörg Zimmermann
Vice President, Vetter Development Service, External Affairs
Vetter Pharma-Fertigung GmbH & Co.

For perspective on this important anniversary for the Aseptic Conference, Pharmaceutical Engineering® spoke with Jörg Zimmermann, Vice President, Vetter Development Service, External Affairs, at Vetter Pharma Fertigung GmbH & Co. KG, and Vice Chair of the ISPE International Board of Directors. Zimmermann is also Chair of the Program Committee for the Aseptic Conference.

What have been the most significant developments presented on at the Aseptic Conference?

This conference has been instrumental in moving developments forward in aseptic processing. When the conference started 30 years ago, processes had not been optimized much from the early days of sterile products, which had their breakthrough with the first hormone extracts in the 1920s and antibiotics during World War II.

When the conference started, RABS [restricted access barrier systems] and isolator barrier systems were still in their infancy and a lot of open questions needed to be resolved: How to design, qualify, and operate such advanced systems? Which previously manual operations can be automated? How about environmental monitoring? By exchanging experiences within this group of industry experts, the technical advancements were accelerated and have shaped the industry. The standards that we have today would not have been possible without this conference.

What was also instrumental was the open and honest exchange with representatives of the regulatory authorities. In the end, we have all helped improve the processes to get to the ultimate goal: to provide safe, sterile medicines to patients, free of microbes, particles, and pyrogens.

What is your favorite conference memory?

This is a difficult question because there are so many wonderful moments. We have had great conferences in Tampa, with cocktails by the pool in February, we met in Baltimore in the snow and people struggled to get there because of the snow, we had conferences in Washington within walking distance of the White House…but the best was always to meet old friends, and to get to know new people from all over the world, not only on a professional level but also on a personal level. Many friendships have formed over the years.

What challenges have you faced in creating the conference each year?

My most challenging task at one time was when a keynote speaker canceled less than 24 hours before going on and we had to rearrange the program—we had 300+ people coming in, expecting to hear the talk! We managed, but it was a close call. In another year, we were threatened by the government furlough, and there was a chance that the FDA representatives would not be able to join.

The key to success is that we have a wonderful program committee that does work year-round on the conference. We have sketches for the conference agenda two to three years out.

Why do you think that this conference has become such a tradition in the industry?

With all the developments that the conference has helped to shape, it has been established as the go-to gathering for aseptic processing. People know that they will hear about the latest and greatest; they know that they will meet the right experts and will get their questions answered. This helps them in their everyday jobs, whether they are new to the field or veterans. The high quality of the content and the open sharing of lessons learned from real-life projects is what makes the conference unique.

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