Disposables COP Articles

Pharmaceutical Engineering Articles

Articles published in Pharmaceutical Engineering, ISPE’s bi-monthly member magazine that relate to the subject matter of the Disposables COP.

• Standardization of Single Use Components’ Extractable Studies for Industry
  May/June 2012, 32(3)
  by Ekta Mahajan, Trishna Ray-Chaudhuri, and James Dean Vogel
• Single-Use Disposable Filling for Sterile Pharmaceuticals ( 292 KB)
  May/June 2003, 23(3)
  by Brett Belongia, Robert Blanck,PhD, and Steve Tingley
• Quantitative Economic Evaluation of Single Use Disposables in Bioprocessing ( 330 KB)
  May/June 2002, 22(3)
  by Andrew Sinclair and Miriam Monge

Other Articles

• FDA GMP Compliance Spotlight Will Remain Centered on Conventional Aseptic Processing ( 536 KB)
  At the ISPE 2012 Aseptic Conference in Tampa, a panel of FDA compliance experts provided important insights on the continuing agency concern with manufacturers that use conventional aseptic processing and can’t demonstrate that the heightened risks of the old technology are under control.
  This article is an in-depth review of the dialogue that took place at the panel session, written by Bill Paulson, Editor-in-Chief of International Pharmaceutical Quality, and originally appearing in IPQ's April Monthly Update. The review was made available to ISPE through a special arrangement with IPQ.
• End to end deployment of single-use technology in aseptic filling at GSK
  Author: Andrew Sinclair, Miriam Monge
  BioPharm International; February 2010
• Disposables in rapid response manufacturing : part 1
  Author: Andrew Sinclair, Miriam Monge
  BioPharm International; August 2009
• Disposables in rapid response manufacturing part 2
  Author: Andrew Sinclair, Miriam Monge
  BioPharm International; December 2009
• User Viewpoints on Disposables Implementation
  Author: Andrew Sinclair, Miriam Monge
  Biopharm International; June 2009
• Disposables Cost Contributions: A Sensitivity Analysis
  Author: Andrew Sinclair, Miriam Monge
  Biopharm International; April 2009
• Evaluating Disposable Mixing Systems
  Author: Andrew Sinclair, Miriam Monge
  Biopharm International; February 2009
• Disposable Technologies Implementation: Understanding and Managing Risks
  Author: Andrew Sinclair, Miriam Monge
  Biopharm International; December 2008
• Disposables Open Up Possibilities in Facility Design
  Author: Andrew Sinclair, Miriam Monge
  Biopharm International; August 2008
• How to Evaluate the Cost Impact of Using Disposables in Biomanufacturing
  Author: Andrew Sinclair
  Biopharm International; June 2008
• Disposable Bioreactors: The Next Generation
  Author: Andrew Sinclair
  Biopharm International; April 2008
• (Single Use) Environmental Considerations for Biomanufacturing Processes
  Author: David Newman
  Published in french in IndustriePharma N°32 - February/March 2008
• Disposable Technologies for Aseptic Filling
  Author: Jan-Eric Zandbergen and Miriam Monge
  BioProcess International; June 2006
• Properties of Materials Used in Single-Use Flexible Containers—Requirements and Analysis
  Author: Magali Barbaroux, Andrew Sette
  BioPharm International; November 2006
• Quantification of Protein Absorption onto the Surface of Single-Use Flexible Containers
  Author: Isabelle Uettwiller, Delphine Dubut, and Nicolas Voute
  BioProcess International; June 2006
• Successful Project Management for Implementing Single Use Bioprocessing Systems
  Author: Miriam Monge
  BioPharm International; November 2006
• Testing & Validation of Disposable Systems
  Author: Isabelle Uettwiller
  Genetic Engineering News; February 2006
• Biomanufacturing for the 21st Century—Designing a Concept Facility Based on Single Use Systems
  Author: Andrew Sinclair and Miriam Monge
  BioProcess International; October 2004

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