DuPont manufactures Tyvek® medical and pharmaceutical packaging styles at production facilities located in Richmond, VA, and Luxembourg that are ISO 9001:2015 certified. Both facilities have a Quality Systems Manual, which is a requirement for certification, and strictly adhere to good manufacturing practices, good laboratory practices and quality control measures.
Sampling and physical property testing are conducted per procedures associated with ISO 9001:2008 quality systems registration. Samples of Tyvek® are taken at the bonder windup, identified and delivered to the in-area laboratory for physical property testing.
All routine physical property tests run on bonded Tyvek® are performed in the in-area laboratory. This quality control testing is intended to satisfy product characterization, process control and measurement control. DuPont uses test methods that are based upon recognized industry methodologies from ASTM, ISO and other organizations to measure the physical properties of Tyvek®.
Samples are managed using the laboratory information management system (LIMS). Every sample is identified with a LIMS sample label. The sample label contains all necessary information needed to track a test result back to finished product.
Laboratory data is generated following established procedures and guidelines, which include good laboratory practices, such as timely instrument calibrations. The laboratory data is kept for up to 10 years.
A description of sampling plans for specification properties and miscellaneous properties can be found in the DuPont Technical Reference Guide for Medical and Pharmaceutical Packaging.
Tyvek® medical and pharmaceutical packaging styles comply with the materials portion of the ISO 11607-1:2006/Amd.1:2014 Standard. The DuPont™ Tyvek® Compliance to ISO 11607-1:2006/Amd.1:2014 guidebook can be downloaded by registering here.