New Low Density Polyethylene Grade for Pharmaceutical Packaging

LyondellBasell Industries has launched Purell PE 3420F, a new low density polyethylene (LDPE) grade for use in pharmaceutical packaging. With a density of 0.933 g/cm3, this product sets a new performance benchmark for commercial LDPE production. Purell PE 3420F resins process easily and have a wide range of best-in-class mechanical properties. Compared to standard LDPE, the grade has higher sterilization temperature resistance and provides significant wall-thickness reduction potential, which offers various cost-saving capabilities for customers using blow-fill-seal (BFS) technology to produce applications such as infusion bottles.

Reduction of sterilization time through higher density

If sterilization is needed, certain regulations require infusion solutions to be sterilized at 121°C for 15 minutes, even when filled under aseptic BFS processing conditions. However, LDPE typically cannot be sterilized at this temperature due to its melting point which is lower than 121°C. Regulatory authorities accept lower sterilization temperatures, if the treatment time is increased in parallel (equivalence method). Sterilization time for a standard LDPE used in this process may range from 130-195 minutes, and by using Purell PE3420F resins this time can be reduced to approximately 30-50 minutes.

"If the sterilization process is a rate-limiting step in production, Purell PE 3420F resins can address this challenge for customers by providing shorter sterilization times and reduced associated costs through the use of higher temperatures," says Dr. Patrik Schneider, LyondellBasell's Manager for Technical Service and Application Development for healthcare applications. "This can lead to increased confidence levels for customers who decide to employ higher sterilization temperatures."

Potential to save material through higher density

Additional benefits offered by Purell PE 3420F resin's high density and excellent melt strength include the potential for wall thickness reduction while maintaining a high water vapor barrier. Shelf life can be extended while maintaining wall thickness at previous levels. The high melt flow leads to excellent processing and high design versatility. Converters report improved embossing with Purell PE3420F resins. The new grade has the potential to be well suited for intravenous bottle production due to its intrinsically high purity; it is produced without additives and thus has a very low leachables/extractables profile.

"With the Purell 3420F grade, we are truly expanding the operational envelope of our production facilities, as we are achieving densities not classically associated with LDPE," said Thomas Maurer, Operations Manager of LyondellBasell's Purell resins plant in Wesseling, Germany.


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