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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.
We are pleased to present the newly designed Westpharma.com. Our passion for customers goes beyond just the products and services we offer. Our website redesign brings to life our 90+ years of expertise and focuses on simplifying our customers journey to help them find the right solutions for their drug packaging and delivery challenges. Take a fresh look at how our solutions can help you.
Recently, the generics pharmaceutical industry in the United States has seen the average time to market decrease significantly as approvals have steadily increased thanks to the introduction of the Generic Drug User Fee Amendments (GDUFA) in October 2012. The reduction in time has led pharmaceutical companies to seek out high-quality elastomer products that provide the regulatory simplicity necessary to bring their products to market quickly, helping to increase a company’s competitiveness and their drug product’s overall sales. The AccelTRA™ elastomer program is built on these features: Quality, Speed, Simplicity.<br />
In aseptic pharmaceutical manufacturing, the packaging for parenteral packaging components is essential for ensuring proper sterilization and utilization. The importance cannot be overstated. Ineffective component packaging can potentially affect patient safety, and result in significant financial loss. Acknowledging this, West conducts exhaustive testing on its packaging systems to ensure that quality and functionality requirements are achieved.
On March 26, the Delaware Valley Chapter of PDA and West Pharmaceutical Services, Inc. co-sponsored a workshop: Defining a Strategy for Combination Products, at West’s headquarters in Exton, PA. More than 150 people from 45 companies that provide drug products and combination products attended. In prior PDA events, combination product regulatory challenges have been cited often as an area both of interest and confusion. This workshop aimed to address them.
A good elastomer stopper for a vial container system needs to have the right properties. These properties are largely determined by the elastomer formulation, which comprises the base elastomer, fillers, plasticizers, and curing agents. The interplay among these components is crucial, as they determine performance. For example, hardness is affected by filler type and level, as well as by curing agent and level. West understands these issues, and therefore is able to develop formulations to offer maximum performance. An example is the formulation 4040/40, which was designed according to quality-by-design (QbD) principles.
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