Tyvek® Rx: June 2015
Whether you are looking for data and documents to assist you with your risk assessments and other regulatory requirements, or you need information to help you select the most appropriate packaging material for your medical device, you’ll find it at the new Tyvek® for Medical & Pharmaceutical Packaging Reference Library.
At this new one-stop resource, you’ll be able to immediately view and download all of the content in the Technical Library, including the DuPont Technical Reference Guide for Medical and Pharmaceutical Packaging, Tyvek® specification and miscellaneous properties, the Tyvek® Compliance to ISO 11607-1:2006/Amd.1:2014 document and so much more. There is also a convenient link to the Are You Ready? website so you can easily access Medical Packaging Transition Project (MPTP) data and documents from the Technical Library.
Premium content contained in the Regulatory Library, such as regulatory letters and Tyvek® MPTP testing certificates, can be viewed and downloaded after you complete a brief one-time registration form. This will enable us to contact you if the information changes or is updated.
And, for those who seek permission to reference the DuPont™ Tyvek® Device Master File at the U.S. FDA or at Health Canada, or the DuPont™ Tyvek® Drug Master File at the U.S. FDA, you will find the Request Permission form here. This request requires you to submit a higher level of information that will be reviewed by our business team.