Primary packaging components come in intimate contact with drug products – they can affect both drug product and patient safety. Many elastomer components are offered with a FluroTec^® film that serves as a chemical barrier to minimize the migration of compounds from the elastomer into the drug product. FluroTec film comprises an ethylene-tetrafluoroethylene co-polymer (ETFE) – selected based upon flexibility, ability to be laminated to an elastomer, and of course, permeability resistance.

The performance of FluroTec film is well known from an empirical standpoint; however the fundamentals of performance have not been examined. West scientists have undertaken actions to address this gap. A theoretical model of permeation of compounds through ETFE film has been developed [Modeling the Permeation Rates of Organic Migrants through a Fluoropolymer Film. L. Fang and C. Zhao. PDA Journal of Pharmaceutical Science and Technology, 73 (1) 70-82 (January–February 2019)]. This model considers and calculates the effect of all critical parameters [film thickness, polymer free volume, size/conformation of permeant molecules, Hansen solubility parameters (polar, non-polar and hydrogen bonding) of polymer and permeants]. Calculations and experimental observations match well for model permeants such as methylethyl ketone.

This approach of combining theoretical and experimental data provides the most complete picture of product performance, and assists in the safe and efficient delivery of drug products. Further, this work may be regarded as a theoretical high-throughput approach to evaluating extractables and leachables. By understanding what compounds are more likely to permeate, always-limited experimental resources can be most effectively deployed. For more information on how West can help, contact an Account Manager or Technical Customer Service (TCS) representative.

 

 

 

FluroTec^® is a registered trademark of West Pharmaceutical Services, Inc. in the United States and other jurisdictions. FluroTec^® technology is licensed from Daikyo Seiko, Ltd.