Unlike plungers made from co-molded components that contain areas of naked rubber and pose the risk of residue transfer, Datwyler’s NeoFlex™ plungers are fully coated using Datwyler’s proprietary spray coating technology. This efficient method provides a robust barrier between drug and rubber to minimize extractables and leachables, and speed time to market.
NeoFlex™ plungers can be offered ready-to-use, minimizing human intervention as another step towards reducing contaminants. The RTU packaging uses double vacuum sealed bags. If ever a puncture in the packaging were to compromise the sterilized plungers, the bag would lose its vacuum seal, enabling customers to easily identify and divert the plungers out of their supply chains.
Datwyler manufactures all of its NeoFlex™ plungers to (smartlink: firstline production standards. The company’s network of FirstLine® facilities marry best-in-class production technologies with fully integrated cleanroom environments. Multiple FirstLine® plant locations around the world ensure multinational options for sourcing.
NeoFlex™ plungers are available in 0.5 ml, 1.0 ml and 2.25 ml sizes for prefilled syringes and in 3 ml for cartridges. NeoFlex™ is the preferred option for proteins prone to degradation and denaturation in the presence of metal ions, silicone oil, oil-based formulations, and other compatibility challenges. Application areas include prefilled syringes for manual application, prefilled syringes in auto-injectors, cartridges in pen-injectors, and siliconized glass and polymer syringes.