September 23-26, 2018
The guidelines for launching new products and manufacturing those approved products are becoming more stringent on a routine basis. Quality certifications, clean room requirements, forwards and backwards traceability on all components are the new standard for providing FDA-approve products. Part of insuring that quality criteria are being met is to understand how the raw material is created, how it is processed in to a technologically useful processing aid (tube) and then how is that tube tested. Thermoplastic resin is the key ingredient in creating TuFlux tubing. The broad chemistry footprint allows specialized compounders to create unique blends of components (using plasticizers, oils, finishing aids etc) to manipulate the material so that it meets USP Class VI standards but still provides the lower levels of leechables and extractables as well as minimize unwanted biological cell growth.
Please click Additional Files below to see the full abstract.
Pradnya Parulekar and Michael Drechsel, "TuFlux TPE tubing for pharma processing" in "Single-Use Technologies III: Scientific and Technological Advancements", Weibing Ding, Amgen Martina Micheletti, University College London Robert Repetto, Pfizer Eds, ECI Symposium Series, (2018). http://dc.engconfintl.org/sut_iii/33