Disposables in Biomanufacturing: An Objective Assessment

BTEC Instructor: Henry Lamb, Ph.D.
ISPE Instructor: TBD

Cancelled 


Advanced Course - ISPE CEUs 1.8

Explore challenges and issues related to the implementation of disposables technology based on current practice in the biotechnology industry and issues that will impact biomanufacturing tomorrow including the impact of implementing disposables technology and equipment on qualification and validation; the current and future issues in operations where disposables technology is not just being used, but becoming more the norm than the exception; and determining the right scale of operation for disposables versus fixed traditional equipment.

Course topics include: assessment of disposables versus CIP technologies; disposable bioreactors – evaluating technology options; cost evaluation methods for disposables; project management for single-use implementation and integration; vendor and technology selection; validation of single-use systems and regulatory considerations; establishing good customer – supplier relationships for single-use technologies; environmental impact of disposables; and case study review.

Hands-on sessions in the BTEC facilities provide experience in: comparison of various disposable fluid transfer systems; comparison of technologies for measurement and sensing of fluids in disposables; buffer, media storage in disposables; disposable vessel mixing devices; and comparison of small and intermediate scale disposable cell culture bioreactors.

Take Back to Your Job

  • How to evaluate your process for implementing an operational platform that includes disposables 
  • Determine current costs and product information that will enable you to evaluate many of the disposable/single-use equipment available today 
  • Awareness of critical design and materials of construction considerations for disposable technologies 
  • Objective methods to evaluate the economics of single-use technologies 
  • Emerging applications of disposables 
  • Methods for validation of single-use devices 
  • How to choose an appropriate technology and single-use vendor

Attendance Suggested For

  • Experienced process scientists and engineers with CIP experience looking to learn about single-use systems integration in their current or future operations
  • Regulatory compliance professionals and quality control personnel seeking to understand approaches to validation of single-use technologies 
  • Process design engineers, project planning and procurement professionals evaluating the economics of disposable technologies

Schedule

Cancelled