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Sterling Kline

RA

Integrated Project Services (IPS)



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Tuesday, March 29, 2011
Conference Program
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Aseptic Processing Facility Design and Machine Integration: A Unique Case Study
Room: 1E14 ~ 2:00 pm - 3:30 pm (Tuesday, March 29, 2011)
The manufacturing of aseptic liquid and lyophilized products presented unique challenges for United Therapeutics and the need for a flexible, multi-purpose facility capable of manufacturing aseptic products in multiple formats was critical. This case study focuses on the innovative design considerations, flexibility, equipment integration and implementation of Barrier Isolation and Blow-Fill-Seal (BFS) technologies for the production of sterile liquid drug products in either glass vials (injectables) or BFS ampoules (inhalation) for worldwide distribution.
Beginning with architectural considerations and followed by technology advances, the speakers will demonstrate substantial space limitations, cost savings and an in-depth look at the many unique, first-time equipment configurations within the 34,000sf facility. This includes the custom designed total single-use disposable technology on the barrier isolator vial line. They will present how strategic and project execution planning ensured the new facility was compliant, addressed the needs for aseptic production, introduced new, advanced aseptic technologies, mitigated risk of cross contamination and assured the microbiological integrity of the finished drug product. Additional innovative design approaches include critical utility accessibility and the latest optimization methodologies for process and operational efficiency.
Speaker:
Sterling Kline - RA, Integrated Project Services (IPS)
Pat Poisson, United Therapeutics
Reed Exhibitions
  • Pharmaceuticals
  • Biologics
  • Generics
  • Contract Services
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