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The needle of a pre-filled syringe is extremely important. From manufacture, through packaging/transportation, to patient delivery – if the needle is not protected, the drug product cannot be delivered effectively. To protect needles to ensure patient safety, West has developed Rigid Needle Shields (RNS) in two sizes: 1/2” for subcutaneous injections (e.g., heparins) and 5/8” for intramuscular injections (e.g., vaccines). RNS consist of a two-part system – a soft rubber inner shell and a perforated, hard polypropylene outer shell. This system maintains container closure integrity (CCI) for both an ISO 11040 glass syringe with staked needle, and a polymer-based syringe (e.g., Daikyo Crystal Zenith® insert needle syringe).
Good performance requires proper design and proper material selection. The rubber inner shell comprises specially-selected polyisprene-based formulations with excellent gas permeability to enable sterilization with either steam or ethylene oxide. West further recommends formulations optimized to resist degradation from ozone exposure (resultant cracking would lead to loss of CCI). To avoid risk of allergic reactions, rubber is not made with dry natural rubber latex. The perforated polypropylene shell enables easy access of steam or ethylene oxide.
In collaboration with commercial partners West has tested RNS rigorously after sterilization. Two sealing areas, one at the tip of the cannula and one on the cone of the syringe, help to ensure good CCI. This was confirmed by high pressure (applied to syringe plunger) leak testing. Simulated air transport (fluctuations in air pressure) likewise showed no loss of CCI. As the tip of the cannula pierces the rubber shell during assembly, there is no issue with coring or fragmentation. Pull-off force measurements demonstrated convenient removal of the RNS from syringe. A further benefit – employment of RNS on a commercial assembly line requires only minor adjustments, and does not require any format part changes.
For more information, contact your Account Manager or Technical Customer Support representative.
The ongoing trend of the pharmaceutical industry is shifting toward pre-filled syringes (PFS) as the optimal delivery system for many drug products. Among other risk factors, the safety of a drug product depends on the quality of the elastomeric components.
The global prefilled syringe market is growing rapidly, and approximately 60% of prefilled syringes use staked needles. To help ensure the integrity of the drug products contained within, the majority of staked-needle prefilled syringes use Rigid Needle Shields (RNS).
Allergy to natural rubber latex was first documented in the late 1970s. The condition now commonly known as “Latex allergy” is caused by the proteins produced from the rubber tree (Hevea brasiliensis) that are still present in the products manufactured from natural rubber latex. This allergy is not only caused by the proteins, but also by the chemicals and/or residues thereof.
Natural Rubber Latex (NRL) has been a topic of concern in the pharmaceutical industry since the early 1990s. Concerns with allergens prompted labeling guidelines to ensure safe patient treatment. West Pharmaceutical Services’ elastomeric formulations for injectable packaging components for vials and syringes may contain Dry Natural Rubber (DNR) in the form of crepe, but the formulations do not incorporate NRL.
This week, West is delighted to be at the Parenteral Drug Association (PDA) Europe Annual Meeting in Berlin, Germany. During the show, we will provide more information on our <a href="/products/prefillable-systems/syringe-components/rigid-needle-shields-and-tip-caps">Rigid Needle Shield </a>(RNS). Designed to provide added safety for prefilled syringes with a staked needle, the West RNS helps assure the integrity of injectable drug products. The West RNS will be showcased along with West’s comprehensive product portfolio and technical insights.
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