PVC Q&A
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We are looking for a PVC compound that exhibits water blush resistance. Do you have any recommendations? This is for PVC calendering film applications.It is difficult for me to recommend specific companies on a blog such as this because of commercial sensitivities. However, I am aware of the phenomenon of water blush in film applications and bag clearing effects and there are companies who I am confident could supply appropriate compounds and recommended procedures to ameliorate such a phenomenon. Therefore I would recommend you attempt to make contact with compound manufacturers and request their help.
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There are legacy PVC medical device products on the EU market that have been used in large volume over at least the past three decades with, presumably, no deleterious effects. They would be expected to fail the current 10993 testing (as PVC is used as a positive control) for the least stringent criteria: limited duration, unbroken skin contact. How would you respond (or expect a manufacturer to respond) to a request from customers or regulators for 10993 test results?I am not sure that I fully understand your question, so please feel free to return to specifically highlight the parts of ISO 10993 which you feel PVC would not meet. In our experience PVC can meet all the relevant parts of ISO 10993, assuming that its use is what it is intended i.e. single use disposable applications. Whilst it is true that some PVC controls are used as positive controls i.e. “failure” these have been specifically designed as such as positive samples to give a cytotoxic response i.e. tin-impregnated strips for use specifically with the ISO 10993-Part 5 methodology. Flexible PVC formulations that were tin-impregnated would not be used in flexible PVC medical devices.
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Ole Grøndahl Hansen received his Master of Arts Degree from University of Copenhagen in 1988. After teaching at the Faculty of Arts, he turned to the plastics industry. Since 1995 he has been General Manager at the PVC Information Council in Denmark. The council was established by the European PVC industry in 1995 and provides information on environmental and health issues related to PVC and communicates information about the positive contribution the PVC material can make to modern society. Prior to joining the council, Grøndahl Hansen was a Communication Manager for Totax Plastics.
Grøndahl Hansen is a member of the Editorial Advisory Board of EMDT and frequently writes articles on PVC and medical device issues. Other topics of interests include social media and how to communicate about PVC and plasticisers via art and design.