ProSeal™ Administration Sets
Customization Ability
ProSeal™ Closed System Administration sets provide the flexibility to customize the setup of secondary infusion, according to specific needs and requirements, enhancing patient ward safety.
Drip-Free Disconnections
The distal connectors of these sets are equipped with ProSeal™ injectors, ensuring secure and drip-free disconnections with Y sites on the primary line.
Versatile Spike Options
The spike ends come in two options - standard bag spikes or ProSeal™ injectors integrated with a drip chamber - for added versatility in fluid management.
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.
The ProSeal™ range of closed system accessories offer user-friendly and effective solutions to enhance current clinical practices.
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EzSURE™ Empty IV Fluid Bags are thoughtfully designed for the secure transfer of a wide variety of IV fluids and medications, positioning them as the ultimate solution in medication administration.
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