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Sterling G. Kline, RA

Aseptic Subject Matter Expert

Sterling Kline

"It is exciting to be a part of the best aseptic design team in the world"

Sterling is a registered architect, licensed construction contractor, and degreed engineer. He has over 50 years of design experience, of which thirty-five years has been in the pharmaceutical industry where he served in senior management roles in engineering, quality and manufacturing departments at New England Nuclear, DuPont-Merck, DuPont Pharmaceuticals, and Bristol-Myers Squibb. Sterling also has over 20 years of experience managing major architectural and engineering firms. He has been at IPS for over a decade and is currently vice president, design and a world-recognized expert in advanced aseptic facility design. Sterling’s design experience includes strategic business planning, master planning, site selection, conceptual design, detailed engineering and construction management for projects ranging up to $2B.

  • B.S. - Civil Engineering, Northeastern University
  • Board of Directors, PharmaDallas
  • New England Nuclear Corporation
  • DuPont Pharma, Inc.
  • DuPont Merck
  • Bristol-Myers Squibb
  • Kline, Sterling. “4th Generation Aseptic Barrier Technology.” Pharmaceutical Processing, April 2013.
  • Kline, Sterling. "The Containment Expert." Pharmaceutical Processing, Vol. 27, No. 7, August 2012.
  • Kline, Sterling. "Case Study: Brazil Fill/Finish: The Role of CMS's in Supporting Global Vaccine Production Needs." Pharmaceutical Processing, IPS Technologies Tours at INTERPHEX 2012 Supplement, March 2012.
  • Kline, Sterling. “Insider’s Perspective on Isolation Technology.” Pharmaceutical Processing, June 2010.
  • Kline, Sterling. "Barrier and Isolation Systems: Technology in Transition." Clean Rooms, Volume 21, No. 47, April 2007.
  • Kline, Sterling. “Isolator Technologies Slowly Catching On.” Genetic Engineering News, Volume 26, No. 21, December 2006.
  • Kline, Sterling. "Current Trends in Aseptic Manufacturing.” White Paper.
  • Kline, Sterling. “Advanced Aseptic Processing Technology, A Guide to Applications in the HealthCare Industry.” Aseptic Processing Facility Design, Chapter 3.
  • Kline, Sterling. “FDA Expectations for Aseptic Facility Design.” ISPE UK Annual Meeting & Expo, November 2017, Birmingham, England.
  • Kline, Sterling. “A Response to the Drug Shortage and a Prototype for a Novel US Manufacturing Model.” SKAN Aseptic Symposium, October 2016, Raleigh, NC.
  • Kline, Sterling. “Risk Based Facility Design.” IMA Aseptic Processing Symposium, September 2016, Buffalo, NY.
  • Kline, Sterling. "cGMP Aseptic Facility Design Based on Barrier Technology." FDA Drug Inspector Training Program DG 330 Active Pharmaceutical, Pre-Approval, and Sterile Drug Inspections, July 2017, December 2016, May 2016 January 2015, May 2014,September 2014, September 2013, June 2013, Washington, DC.
  • Kline, Sterling. "Case Study: Multi-product International Greenfield Vaccine Filling Facility based on Isolator Technology." Barrier Seminar, 24 February 2014.
  • Kline, Sterling. "Current Trends in Advanced Aseptic Processing Technology." IPS Open House, September 2013, Blue Bell, PA.
  • Kline, Sterling. "cGMP Aseptic Facility Design Based on Barrier Technology." FDA Drug Inspector Training Program MP 302 Industrial Sterilization for Drugs and Devices, June 2013, Portland, OR, January 2013, San Juan, PR, Columbus, OH.
  • Kline, Sterling. "Design and Construction of BFS Facilities: A Unique Case Study." BFS IOA Annual Meeting, September 2012, Washington, D.C.
  • Kline, Sterling. "Case Study: Brazil Fill/Finish Facility." INTERPHEX, 5th Annual IPS Advanced Aseptic Tour, April 2012, New York City, NY.
  • Kline, Sterling. "Regulatory Compliant BFS Facility Design." BFS IOA Annual Meeting, September 2011, Charleston, SC.
  • Kline, Sterling. “The Costs of RABS versus Isolator Technology.” ISPE European Isolator Conference, September 2011, Strasbourg, France.
  • Kline, Sterling. “United Therapeutics: Advanced Aseptic Processing Case Study.” 4th IPS Advanced Aseptic Tour, INTERPHEX, March 2011, New York City, NY.

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