West Scales Up Rigid Needle Shield Production in Stolberg
For customers seeking a rigid needle shield (RNS) solution for prefillable syringe systems, West manufactures components that are free of dry natural rubber, meet all global regulatory expectations and have unique properties that will allow for steam or ETO sterilization. In addition, our 7028/55 formulation is the only formulation on the market that is designed to resist cracking caused by environmental conditions, including ozone.
“As a result of high global market interest and several customer projects moving to a commercialization phase, West has scaled up to a fully automated assembly process in our Stolberg, Germany, facility to ensure that we meet customer demand,” noted Tibor Hlobik, Director of Marketing, Prefillable Syringe Technologies.
From a design standpoint, the plastic cover RNS was developed with needle shield geometry and elastomer material identical to West’s soft needle shield designs. Moving from a soft to a rigid needle shield can be qualified quickly, does not change drug contact and may help to ease any regulatory transition.
West’s RNS are produced in a clean room environment, controlled to meet high quality specifications and provide added safety for insert- and staked-needle prefilled syringe systems.
Rigid needle shields:
Reduce needle tip damage
Allow a better grip of the needle cover
Offer easier un-shielding by auto-injection systems
May aid in reducing the risk of needle stick injuries
West’s premier elastomer formulations have been designed to be compatible with prefilled syringes made of glass, cyclic olefin polymers and other plastic systems. The sealing properties of our formulations help to assure packaging integrity. These formulations offer:
Permeability for sterilization
Optimized pull-off forces
Cleanliness and compatibility with drug products
Ozone resistance (low cracking)
West’s components are backed by the strong technical support and global expertise of our Technical Account Services and Regulatory teams. Contact your account manager today to discuss how rigid needle shields can aid your prefillable syringe system.