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2020 ISPE Annual Meeting & Expo

SES407 - A Historic Legacy Facility Strengthening Its Future of Aseptic Processing

Nov 6, 2020 11:30am ‐ Nov 6, 2020 1:00pm

Expiration Date: Nov 30, 2021


Session Description:
In the ever-evolving environment of parenteral product manufacturing, legacy facilities are struggling to meet current expectations for cost reduction, flexibility and regulatory compliance. These once state-of-the-art facilities are looking for a practical approach to modernization, to continue manufacturing high quality products while they plan for the future.
Par Pharmaceuticals has done just that through its investment in their Rochester Facility, a site that has an important role in the history of the pharmaceutical industry. The Suite C expansion project resulted from master plan efforts that considered multiple important facets of the upgrade, including technology, facility compliance and workforce development.
Bryan Kistner will discuss the owner side challenges of producing products in today’s parenteral environment. He will also discuss what it is like to navigate the internal complexities of bringing such a project from initial conception to successful completion.
Paul Valerio will discuss the latest technology being used in Suite C with the adoption of isolators, automated material handling, and the nuances of multi-product concurrent manufacturing.
Jason Collins will discuss the importance of master planning and establishing a future vision along with the details of facility design aimed at flexibility and regulatory excellence.

Session Leader(s):


  • Bryan Kistner, MS Mechanical Engineering, Senior Director - Eng Program Mgmt, Par Pharmaceuticals Inc
  • Paul F. Valerio, Director, Process Technology / Associate, IPS - Integrated Project Services, LLC

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