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In the prefilled syringe system, the plunger is in contact with the drug product during administration and the drug storage period, which may last up to two years and can affect the long-term stability of the drug product.
Interactions between a drug product and its packaging can have a significant impact on the purity of a drug and the safety of patients. With drug impurities and degradation among the primary causes of drug recalls, management and control of associated risks should dominate product development and manufacturing processes. The selection of the right plunger for a prefilled syringe system is therefore an important consideration for the pharmaceutical and biopharmaceutical industry.
Fluorpolymer films (such as the FluroTec® barrier film coating) provide an effective barrier against organic and inorganic extractables, minimizing the interaction between the drug and the plunger while maintaining the plunger’s seal integrity. These film coatings can reduce the leaching of extractables into the drug product. Further, FluroTec barrier film reduces absorption and adsorption of the drug product, an important benefit for maintaining the full strength and shelf life of most drugs. In addition, the low surface energy of the film provides lubricity without the need for silicone oil, eliminating one source of particulate contamination.
West flurpolymer film-coated plungers are designed according to the ISO 11040 requirements for glass dimensions part 4, and are available in: 0.5 mL, 1 mL long, 1-3 mL, 5 mL and 10 mL formats; additional sizes and configurations are availed on request. FluroTec film coated plungers have been on the pharmaceutical market for 25 years, with a high number of registrations in the overall worldwide pharma market. Fluorpolymer coated plungers have become a standard for many drug products, especially in the biological field, and are typically easily processed.
New generations of plungers with FluroTec coating were developed over the last five years to answer ever-increasing quality and regulatory requirements and market trends toward home administration that may require different application formats, such as auto injectors. Functionality profiles for auto injector applications have different requirements. All these requests have been addressed by developing a new generation of plungers, NovaPure® plungers.
Contact us to speak with a Technical Customer Service representative to learn more about the benefits of fluorpolymer coated plungers.
NovaPure® and FluroTec® are registered trademarks of West Pharmaceutical Services, Inc. in the United States and other jurisdictions.