October 18-21, 2015
Ensuring a good product requires specifically a combination of selected parameters covering materials, processes & controls / testing. This presentation will show how these concerted activities lead to deliver a good film matching the application needs in Biotechnology applications
Material properties: Bags are formed out of a plastic film by different sealing technologies, using heat, ultrasonic sound or electric fields. Key critical parameters vary from sealability, mechanical & barrier properties, leachables & extractables, surface specification, melt flow properties, gel count, transparency …
Process + Machine: Extrusion or lamination processes have some technical limitations and machines most relevant topics would be width of film, thickness, polymers + film layers, mechanical properties, and of course environmental conditions.
Monitoring and Controls: In the film industry continuous inline measurement of the thickness is a standard. Beside those in-line controls, off-line laboratory, process data collection and sampling library provide the backbone of process control.
Ralf Reiser, Stefan Jendrosch, and Ingo Schnellenbach, "Overview of the links between material properties and film extrusion process" in "Single-Use Technologies: Bridging Polymer Science to Biotechnology Applications", Ekta Mahajan, Genentech, Inc., USA Gary Lye, University College London, UK Eds, ECI Symposium Series, (2015). https://dc.engconfintl.org/biopoly/6