Hear more from Sterling and Jason as they share their experiences and knowledge of aseptic technologies and facility design in ApiJect's Fill Finish Podcast.
"It was way back when in 1978 that we started with aseptic processing. That was really at the beginning of the technology throughout the industry, and it has evolved over the past two generations. In the very beginning, we were all learning and so typically, from an architectural standpoint, we were building facilities that look like any other facility in the world and we really did not understand the technology of clean rooms and the technology involved with that. Both from an architectural standpoint and buildings, mechanical, the whole building process, but then also from an equipment side, and all of that has evolved."
"In the early 2000s, we saw some things happening, which really created some chaos, but also gave us some direction. We had some new guidance coming out from the FDA, I believe in 2004, they had their newer guidance for industry for sterile facilities. Surely before that I think a year before that the European Commission also issued their version of sterile guidelines in their Annex One documentation. So now all of a sudden, you're getting some direction. You're getting some guidance. You're not being told exactly what to do, because it's guidance, but now all of a sudden there's something to follow. So the big challenge at that time was you had you know hundreds or probably thousands of manufacturing facilities around the world that now were in a state of assessing where are we with this guidance. Are we in compliance? Are we out of compliance? How long are they going to allow us to operate the way we are operating? And I think they were starting to get some feedback from the auditors and inspectors saying hey you really need to be moving in this new direction, we're smarter now, the science is better. We know where we have issues, and you should be starting to address those for better products and better patient safety."
Sterling Kline, RA has over 45 years of expertise in strategic planning, master planning, programming, design, construction management, and facilities management for the healthcare, pharmaceutical, and biotech industries. Sterling is a Subject Matter Expert in Sterile Facility Design and is considered the foremost expert in state-of-the-art sterile isolator technology. He is a well-known figure in the sterile industry and the sterile equipment vendor community and regularly participates in speaking engagements on sterile facility design throughout the world and is involved with the FDA’s training strategy development.
Jason Collins, AIA is the Director of Process Architecture with IPS-Integrated Project Services, LLC. He has over 20 years of experience leading the design of pharmaceutical facilities for various clients around the world and is well known for his knowledge on barrier technology and Advanced Aseptic Facility Design. With a focus on integration, his designs lead to world class facilities that not only produce product, but can be maintained and operated efficiently and safely. Jason is a registered architect and has a degree in Architecture from The Pennsylvania State University.
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Jason S. Collins, AIA
Director of Process Architecture
Sterling G. Kline, RA
Aseptic Subject Matter Expert