ProSeal™ Accessories
MRI Safe
Various ProSeal™ accessories have been crafted especially for MRI procedures with no metal parts included.
Syringe Add-On
ProSeal™ accessories offer solutions for syringe to syringe transfer, subcutaneous safety sets, as well as for chemo safe syringe use.
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 SMARTeZ® Soft Shell pump is a breakthrough in medication delivery technology. With its specially designed balloon-like reservoir, this infusion pump offers a one-of-a-kind solution for controlled and precise drug or fluid delivery. Unlike traditional infusion pumps, the SMARTeZ® Soft Shell pump delivers a range of unique advantages that redefine the infusion experience.
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Upgrade infusion system to SMARTeZ® Rigid Shell pumps and discover a world of innovation that redefines medication delivery. SMARTeZ® Rigid Shell pumps offer an array of exceptional features and benefits that ensure patients receive the best care possible.
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ProSeal™ Administration Sets offer a secure and flexible solution for fluid administration, featuring versatile setups to meet specific patient needs.
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