Datwyler expands its range of NeoFlex coated plungers
Altdorf, Switzerland – Datwyler announces the expansion of 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 (Booth 20B48), the company unveiled its NeoFlex Prefilled Syringe 10ml and its NeoFlex Cartridge Wearable 10ml plungers. 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.
“If you’ve seen a loved one battle cancer, you know that time is precious – and so is the patient’s power to control how they spend it. Auto- and wearable injectors stand to give millions of patients more power over their time in treatment. That represents a monumental shift in healthcare but it all rests on the quality and performance of these devices. Every component matters.” said Dirk BorghsDirk Borghs, COO Healthcare Solutions.
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 with cleanroom environments, automated production cells, and 100% camera inspection.
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 leading 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. Even more innovations are on the horizon.