Datwyler Launches NeoFlex Plungers at CPHI Milan 2024

Datwyler, a provider of elastomer components, launched the NeoFlex Prefilled Syringe 10mL and NeoFlex Cartridge Wearable 10mL at CPHI Milan on Oct. 8, 2024. The new coated plungers are designed for large-volume injectables and are part of the company’s NeoFlex line, which includes the 0.5, 1, and 2.25 mL prefilled syringes, along with the 3 mL cartridge plungers.

According to the company, the desire for at-home care for chronic illnesses has increased the use of auto- and wearable injectors so that patients can self-administer treatments for conditions such as autoimmune diseases, neurological diseases, and cardiovascular diseases. These treatments are often large volume subcutaneous biopharmaceuticals (LVSCs), which are high-concentration and higher-viscosity formulas sensitive to impurities.

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 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,” said Dirk Borghs, chief executive officer of Datwyler Healthcare Solutions, in a press release (1). “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.”

The new additions to the NeoFlex line, like the current offerings, are covered in a non-fluorosurfactant grade fluoropolymer coating to prevent rubber particulates from shedding and to minimize 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,” the company stated in the press release.

Because the plungers are naturally lubricious, silicone is unnecessary for smooth operation inside the syringe or cartridge barrels, and compatibility with complex formulations is supported, which offers effective delivery of a highly sensitive, highly viscous biologic.

Highly viscous products require certain processing techniques, such as pump choice, to minimize costs and ensure 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 company stated.

Datwyler can be found at Booth 20B48 at CPHI Worldwide in Milan, Italy, which is being held from Oct. 8-10, 2024.

Reference

1. Datwyler. Datwyler Launches NeoFlex Plungers for Large Volume Biologics in Auto- and Wearable Injectors. Press Release. Oct. 8, 2024.