leachables
Creating Effective Leachables and Extractables Testing: Whose Responsibility Is It?
April 20 by Eric LangerThe problem of leachables and extractables (L&E) in single-use devices continues to hound both suppliers and end-users, and remains one of the more challenging issues inhibiting regulatory accep...
Under the Microscope: Extractables and Leachables in Single Use Systems
November 27 by Pharmaceuticals & Biotechnology EditorWith the release of the PDA Technical report 66 in mind, the adoption of single use systems has been again moved to the top of discussions in biomanufacturing and extractables and leachables is prov...
Hot Topics in Single Use Systems
November 27 by Pharmaceuticals & Biotechnology EditorWith the recent release of the Parenteral Drug Association‘s (PDA) Technical Report 66, many companies are taking another look at single use systems to see whether it w...
New Territory: Extractables & Leachables in Disposable and Single-Use Manufacturing Systems
November 25 by Andrea CharlesIn this exclusive interview Alain Pralong, VP New Product Introduction and Technical Life Cycle Management at GlaxoSmithKline Vaccines, speaks to Andrea Charles from Pharma IQ, about the challenges&...
Improve Communication between Suppliers and End-Users in the Disposables Biomanufacturing Industry
April 24 by Pharmaceuticals & Biotechnology EditorSingle Use Device Adoption Impacted by Slow Standards Setting
October 10 by Eric LangerBioPlan Associates’ 8th Annual Report and Survey of Biopharmaceutical Manufacturing, 2011, identifies the growing need for standards to support rapidly emerging and evolving single use, dispos...
Alain Pralong on Sound Risk Management in Biomanufacturing
April 23 by Alain PralongAlain Pralong, VP New Product Introduction and Technical Life Cycle Management at GlaxoSmithKline Vaccines, speaks to Pharma IQ, about the challenges faced evaluating single-use systems for ext...