ProSeal™ In Line Pump Set
Efficient Spike Adaptor
This set acts as an adaptor for the spike of an infusion set, allowing easy connection and disconnection to IV containers with a push and pull action in a closed system.
Built-In Spillage Prevention
The tear-off port features an in-built membrane that prevents spillage, even if the infusion spike has not been inserted.
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™ Administration Sets offer a secure and flexible solution for fluid administration, featuring versatile setups to meet specific patient needs.
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Several antineoplastic agents contain an incompatible solvent, DMA (N,N-Dimethylacetamide), in its undiluted form. Some medicines, for example, require dilution before use with devices made from polycarbonate plastics, which are commonly found in IV administration devices, including some closed system transfer devices (CSTDs). By using the appropriate models of ProSeal™ bag spikes and in-line pump sets, pharmacists and nurses can ensure easier and safer work processes.
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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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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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