At the BioProcess International Conference (BPI) in October, EMD Millipore launched their new PureFlex\u2122 Plus single use fluid management film as an addition to their existing PureFlex\u2122 film. The PureFlex\u2122 Plus film provides a more robust option designed for high volume\/value applications.\r\n\r\nPolymetric film is used in single use technologies for fluid management. The film is a key component and its failure can lead to process failure and loss of buffer, media or product. When film fails it often occurs due to abrasion, cracking during film flexing, punctures and stretching. When considering the film to use in single use technologies it is critical to take into account not only physical strength, but also its extractables profile to be sure that the film isn\u2019t releasing deleterious materials that could impact culture or final product quality.\r\n\r\nEMD Millipore had set a goal to create a film that was stronger and more resistant to leaks, but maintained the same consistent, high quality extractables profile that they had achieved with their PureFlex\u2122 film product. Maintaining a consistent extractables profile was important in order to minimize revalidation efforts for customers who would want to make the change from PureFlex\u2122 to PureFlex\u2122 Plus.\r\n\r\nAfter lengthy rounds or research and development, twelve prototypes were developed. Ultimately the current prototype was selected because it offered the best resistance to leaks and tears and involved only a change to the outer layer meaning that there was no change to the layers with fluid contact.\r\n\r\nThe major changes in PureFlex\u2122 Plus are that it is slightly thicker and the outer layer has been changed from ULDPE (ultra low density polyethelene) to the more abrasion resistant LLDPE (linear low density polyethelene). These changes resulted in many improvements in leak resistance when compared with PureFlex\u2122 film including:\r\n\r\n \tAbrasion resistance \u2013 2X higher with PureFlex\u2122 Plus\r\n \tFlex cracking resistance \u2013 statistically fewer pin hole leaks from flex cracking\r\n \tPuncture resistance \u2013 13% higher force required to puncture with PureFlex\u2122 Plus\r\n \tStretch resistance \u2013 30% higher tensile strength with PureFlex\u2122\r\n\r\nThe other critical goal was to maintain an extractable characterization that was equivalent to PureFlex\u2122 film. As a result of not making any changes to the fluid contact layers, the team did not anticipate any changes in the extractables profile between PureFlex\u2122 and PureFlex\u2122 Plus. After extractables characterization, it was found that PureFlex\u2122 and PureFlex\u2122 Plus had no statistically significant differences in the extractables profile and that PureFlex\u2122 Plus was also in line with industry draft recommendations (BPSA BPOG).\r\n\r\nI was able to interview Michael Felo, Product Group Manager, Single Use, EMD Millipore about the new product. He told me the product is perfect for applications greater than 200 liters where physical stresses are higher as the increase in volume adds additional weight. This is particularly important in buffer and media prep where large volumes and storage is fundamental. Michael also shared that all bag sizes are currently available in PureFlex\u2122 Plus, which makes it a very easy transition for customers wanting to move from PureFlex\u2122. While revalidation efforts are always a decision made by the end user, EMD Millipore has taken great effort to make revalidation easier by keeping revalidation in mind during design of the new product and in publishing a white paper that demonstrates equivalency with PureFlex\u2122.