ProSeal™ Injectors
Universal Syringe Compatibility
ProSeal™ Injector is a syringe adapter with a port that fits to any size syringe with an ISO Standard male Luer Connector.
Innovative Safety Measures
The ProSeal™ Injector features an elastomeric membrane and an embedded stainless-steel needle for enhanced safety and content protection.
Complete Sealing / Content Safety
Unlike needleless connectors, ProSeal™ Injectors ensure the complete sealing of syringe contents. They open a fluid path only when connected to a ProSeal™ CSTD’s component, preventing content exposure and without any residue after administration.
Efficiency and Time Savings
ProSeal™ Injector simplifies connections to a patient's access site with a simple click and quick push-pull actions. This efficient design saves time, especially in high workload situations, and eliminates the need for screw thread rotations.
Minimal Residual Volume
The residual volume of ProSeal™ injectors is only 0.02 ml, reducing waste and maximizing medication delivery.
DMA Compatibility
The fluid path materials are DMA compatible, meeting industry standards for medication transfer safety.
Versatile Connection Options
ProSeal™ Injector can be attached to various infusion sources, including IV Lines from Infusion Pumps, SMARTeZ™ Pumps, or Gravity Bags. This versatility offers cost savings and flexibility in managing device inventory.
Dry Disconnect Technology
Designed for easy and efficient operation, ProSeal™ Injectors ensure dry disconnection – each and every time - optimizing medication administration process.
COMPLIANCE
INTERNATIONAL REGULATORY STANDARDS
European regulatory bodies, including the European Medicines Agency (EMA) and national authorities, are actively engaged in developing and implementing comprehensive regulations and standards for CSTDs. These standards are designed to ensure the safety, efficacy, and quality of CSTDs across the European market. The harmonization of regulatory requirements promotes consistent and standardized use of CSTDs in diverse healthcare settings.
NIOSH REQUIREMENTS
PRoSeal™ CSTDs meet the NIOSH requirements for closed system transfer devices, mechanically preventing the transfer of environmental contaminants and the escape of hazardous drugs or vapor concentrations. For instance, ProSeal™– ToxiSeal Vial Adaptors, are equipped with an external balloon, in addition to a 0.1 micron sterile filter and activated carbon filters.
PHARMACEUTICAL SAFETY STANDARDS
ProSeal™ CSTDs are FDA ONB & FPA code cleared and compliant with USP<797> and USP<800> standards, demonstrating their commitment to pharmaceutical safety regulations.
TESTS
PROVEN MICROBIAL INGRESS PREVENTION
ProSeal™ CSTDs have been rigorously tested and confirmed to prevent microbial ingress for at least 168 hours after 10 activations, ensuring long lasting effectiveness.
ERGONOMICS
USER-FRIENDLY PUSH/PULL ACTION
ProSeal™ Devices feature a quick and simple Push/Pull action, eliminating the need for repetitive rotation and reducing the risk of RSI-type injuries (Repetitive Strain Injuries).
OPTIMIZATION
COST EFFECTIVE & EFFICIENT
Beyond safety, the design of ProSeal™ CSTDs enables efficient manufacturability, resulting in competitive pricing.
ProSeal™ Vial Adaptors are designed to fit diverse stoppers on medication vials made by various manufacturers. Crafted with precision and functionality in mind, they offer a seamless and efficient solution for medication preparation and administration.
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The ProSeal™ range of closed system accessories offer user-friendly and effective solutions to enhance current clinical practices.
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