Datwyler, a provider of system-critical elastomer components, has expanded its NeoFlex range of coated plungers with new sizes for containers aimed at large-volume auto-injectors and wearable devices.
 
At CPHI Worldwide in Milan, Italy, the company unveiled its NeoFlex Prefilled Syringe 10ml and its NeoFlex Cartridge Wearable 10ml. Designed to meet the highest quality and safety standards, the new plungers stand up to the unique challenges of delivering large volume injectables through these devices.
 
Use of auto- and wearable injectors is on the rise, driven by the embrace of at-home care for chronic diseases. These devices support the self-administered treatment of certain cancers as well as autoimmune, neurological, and cardiovascular diseases with large volume subcutaneous biopharmaceuticals (LVSCs). Often, the injectables that must be administered are high-concentration, and higher-viscosity formulas that are sensitive to impurities. These drugs are expensive to manufacture and distribute, requiring the utmost attention to every component to uphold patient safety and prevent instances of contamination that can lead to recalls.
 
Datwyler’s new plungers deliver all the benefits of the NeoFlex range in an ideal format for use in auto- and wearable injectors. Designed to ensure the stability and safety of large-molecule drugs, NeoFlex plungers are completely covered in a non-fluorosurfactant grade fluoropolymer coating that prevents the shed of rubber particulates and minimizes degradation from extractables and leachables. NeoFlex plungers are manufactured at Datwyler’s FirstLine facilities to ensure highest level of quality assurance and risk mitigation.
 
NeoFlex plungers are inherently lubricious, eliminating the need for silicone to ensure smooth operation inside the syringe or cartridge barrels while supporting compatibility with complex formulations. This attribute is especially crucial to the effective delivery of a highly sensitive, highly viscous biologic.
 
Additionally, the handling of highly viscous products requires careful selection of processing techniques such as pump choice, to minimize costs and ensure consistent product quality. Datwyler worked closely with pharmaceutical companies and system integrators to design the new NeoFlex plungers for superior machinability when filling larger cartridges with minimal headspace and controlled plunger compression. This collaboration is essential to support effective commercialization.
 
The 10 ml Prefilled Syringe and 10 ml Cartridge Wearable plungers join Datwyler’s ever-expanding NeoFlex family which already includes the 0.5, 1, and 2.25 ml PFS, along with the 3 ml cartridge plungers.