Aseptic Expertise
Sterling Kline, RA
Sterling is a subject matter expert in Aseptic Facility Design and is considered by many to be a leading authority in state-of-the-art sterile isolator technology.
Contact Sterling at 888.366.7660 or aseptic@ipsdb.com .
Proven Leader in Advanced Aseptic Processing Technologies
We are internationally recognized as experts in advanced aseptic processing and risk-based barrier technology. Our team offers innovative strategies and a solid understanding of the risks associated with the handling of potent and cytotoxic compounds, recommending and incorporating appropriate strategies into a fast-track schedule.
- Worldwide Aseptic Design Capabilities; Successfully Completed Aseptic Projects on 5 Continents
- Strategic Business Planning for Advanced Aseptic Processing
- Compliance Risk Evaluations and Assessments
- Outstanding Relationships with Respected Aseptic Processing Equipment Vendors
- Using Sterile Enclosure Technology for OEL Containment and Performing Aseptic Manipulations such as liquids into nested syringes
- Experienced in the application of FDA, EU Annex 1, Canada, China, Japan, Brazil and World Health Organization Regulations and Guidance
- Designed and Upgraded over 20 Filling / Capping Lines to meet EU Annex 1 guidance.
- Advanced Aseptic Team of Subject Matter Experts who Lecture Worldwide and Contribute to Prominent Industry Publications
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Our innovative manufacturing strategy for BMS’ Clinical Supplies and Drug Product Technology Center, the first approved clinical sterile continuous process isolation facility in the United States, won the 2008 Facility of the Year, Equipment Innovation. |
Expert Insight
"Barrier and Isolation Systems: Technology in Transition", Aseptic Expert Sterling Kline, RA quoted in CleanRooms, Volume 21, No. 4, April 2007
"Isolator Technologies Slowly Catching On", Sterling Kline quoted in Genetic Engineering News, Vol. 26, No. 21, Dec 1, 2006
