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Parenteral Drug Association Connecting People, Science and Regulation ®

PDA Metro Chapter Flexible Facilities Event

Oct 17 - Oct 17, 2017 |
Oct 17, 2017 |
FairBridge Hotel & Conference Center | Somerset, NJ
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This exciting program is a vendor showcase plus a seminar on Flexible Facilities presented by Maik W. Jornitz, G-CON Manufacturing Inc.

Date: Oct. 17, 2017, evening
5:00– 7:30 pm     Registration, Cash Bar, Food, Vendor Booths
7:30 - 8:30 pm     Welcome, Seminar, Closing Remarks & Announcements
Location: Holiday Inn, 195 Davidson Ave, Somerset, NJ 08873

Topic and Speaker

Flexible Facilities – The Capabilities of Modular and Prefabricated Cleanroom Infrastructures, presented by Maik W. Jornitz, President and CEO, G-CON Manufacturing Inc
Over the last few years, biopharmaceutical-processing platforms moved from rigid traditional stainless steel to flexible single-use technology. The platforms created the ability to run the process more efficient, intensified and with higher agility.

The need to evolve from fixed and rigid to flexible and agile systems did not stop with processes, but now shifted focus to facility designs. Traditionally the facilities build, were product dedicated, large if not convoluted and involved lengthy time-to-run periods. To build such facilities thorough planning is required, especially capacity planning since the inflexibility of the structure does not allow easy scaling of the cleanroom space required. Overall, these type of manufacturing systems do no accommodate the need for flexibility of scale, multi-product purposes, neither the benefits of single-use technology processes.

Consequently, new facility systems are being introduced into the industry, ones that can be scaled, easily deployed and moved, if necessary. Prefabricated cleanroom units now replace inflexible stick-built structures, which are rigid and prone to faster degradation if not mold issues. Prefabricated units are build off-site in a few weeks and moved into the shell building in hours. The shell building is erected parallel to the production of the mobile cleanroom units. Such structures create flexibility, scalability, but moreover repurposability. Prefabricated systems allow also platform designs and possible integration of equipment to be drop shipped to the location needed within a cleanroom infrastructure.


Maik W. Jornitz, CEO of G-CON Manufacturing Inc., is a technical expert with over 30 years of experience in bioprocesses, especially sterilizing grade filtration and single-use technologies, including regulatory requirements, integrity testing, systems design, and optimization. Jornitz has published 10 books, 15 book chapters and over 100 scientific papers. He is Chair of the PDA Science Advisory Board, task force member of Aging Facility and Post Approval Change Task Forces, as well as working member of BPOG, an advisory board member of the Biotechnology Industry Council, ICAV and multiple science journals. He recently has been recognized as one of the top ten global industry influencers. As a faculty member of multiple training activities, including PDA TRI, he trains members of the industry and regulatory authorities on a frequent basis. He received his M.Eng. in Bioengineering at the University of Applied Sciences in Hamburg, Germany and accomplished the PED program at IMD Business School in Lausanne, Switzerland

Registration

$49 pre-registered PDA Member
$64 pre-registered non-member
$75 at the door
Special discount for same company multiple registration; contact PDAMembership@pda.org to take advantage of this discount.

No cancellations after Oct. 9, but substitutions are welcome!

Vendor registration $300 - REGISTER HERE, or, for questions please contact Kimberly Sikes

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=3863

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