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What's Next for Aseptic Processing in Pharma?

Klaus Ullherr
What's Next for Aseptic Processing in Pharma?

Aseptic filling of parenterals is one the most challenging tasks within pharmaceutical manufacturing. There is a wide range of topics that fall under this umbrella, from more engineer-driven topics like filling accuracy and machine performance to key production questions, like how to keep the process sterile and compliant with the law and the regulatory guidelines. All this is influenced by new methods and technology innovations, either process- or technology-based. Keeping the implementation and operations involving new technologies and updated processing approaches cost-effective is essential to production and must be carefully and intentionally planned out. The right decisions have to be made fast!

2020 ISPE Aseptic Conference banner

At the upcoming 2020 ISPE Aseptic Processing Conference, March 2-3, in Bethesda, MD, you can learn first-hand how people within our industry have been facing these challenges and what solutions they have employed to successfully manage them. The program is filled with in-depth presentations, interactive panel discussions with industry and regulatory experts, and small group discussions on critical topics to offer attendees multiple opportunities to gain insights to take back to their companies. The education sessions and the opportunities to meet with professionals from around the world during breaks and social events gives you a unique chance to discuss more deeply the current activities and problems you may be facing in your daily work life.

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

I feel honored to be the wingman for the chair Jörg Zimmermann for the Aseptic Track the 7th year in a row. My special interest for quite some time has been the use of robotics, especially in the area of/fill finish. I would love to have the opportunity to meet you at the conference and discuss in person our mutual interests and practical solutions to address challenges in fill finish. Some years ago, we have had a dedicated track at the Aseptic Conference that included interactive panel discussions with machine suppliers and engineering companies. The interest has been huge, I could sense that. In 2018, I moderated a workshop about robotics and the engagement of the attendees was amazing. We have generated a lot of ideas, such as trouble shooting by a robot, fully automatic size part change or settle plate handling by a robot, to name a few. In the meantime, I am convinced that for most of the tasks the following statement applies: “What can be automatized, will be automatized”. Because there is a need to keep the impact of human beings out of the process – either to protect the product or to protect the operator or a combination of both. The technology is there. And it is getting cheaper and simpler to apply day by day. At the 2020 ISPE Aseptic Processing Conference you will have the opportunity to hear case studies of well-known pharma companies and you will be able to connect to suppliers and users of the technology directly. In the end, the conversations held at the conference have the potential to revolutionize the whole manufacturing process, with the fully automatic plant on the horizon.

One persistent topic that is still of huge interest is the use of disposable equipment that is finding its way more and more into the whole production chain and now, conquering the last route – the fill/finish path. You will learn from a recent clinical trial project what benefit and also what challenges you will encounter when you change from stainless steel to disposables. In one of the sessions, we will also identify the needs and the solutions for different kind of clinical trial set-ups. The session will give the attendees the unique opportunity to discuss their individual challenges and also their experiences with like-minded people and then to work together on potential solutions. The education sessions are also great networking opportunities.

Our group discussion topics this year will give us all the opportunity to have extensive discussions around topics such as cell and gene therapy implications for aseptic processing, implementation strategies for new robotics applications, and small-scale/clinical batch production issues impacting sterile products processing.

Overall, I am very proud to be a part of the conference committee and of the program we will be offering. My Program Committee colleagues and I have worked very hard to bring you a comprehensive technical program to address your company’s challenges and aspirations for the development of your aseptic processes. We are all looking forward to seeing you in Bethesda!

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