ProSeal CSTD

ProSeal CSTD

ProSeal™ closed system transfer devices (CSTDs) are specially designed to enhance the safe transfer of medication, minimizing exposure throughout the entire drug delivery process — from pharmacy compounding to patient administration. ProSeal™ ensures airtight drug transfer with a minimal number of components, significantly enhancing the safety of healthcare professionals by reducing the risk of exposure to hazardous drug liquids and vapors. Notably, with ProSeal™ CSTDs there is no need for extra filters and works seamlessly with standard syringes.

ProSeal CSTD

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.

Epic Products

ProSeal™ Accessories

The ProSeal™ range of closed system accessories offer user-friendly and effective solutions to enhance current clinical practices.

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ProSeal™ In Line Pump Set

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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ProSeal™ Bag Spike

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ProSeal™ Administration Sets

ProSeal™ Administration Sets offer a secure and flexible solution for fluid administration, featuring versatile setups to meet specific patient needs.

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ProSeal™ Bag Adaptor

With ProSeal™ Bag Adaptor, with its patented mechanism, upgrades most standard fluid bags to a Closed System Bag.

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ProSeal™ Injection Site

ProSeal™ Injection Sites are designed to fit any standard Luer connection. When used with the ProSeal™ Injector, any access site will remain dry after each administration or withdrawal, up to 10 times, provided that the same active ingredient is applied.

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ProSeal™ Injectors

ProSeal™ Injector is the epitome of safety, versatility, and efficiency. Embrace the future of syringe adapters, offering both healthcare professionals and patients unparalleled peace of mind during every administration.

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ProSeal™ Add Mixture Device (ADRx)

Pharmacists and nurses can now expand their capabilities without limitations in bag types or hospital compounding and infusion procedures. Whether in the pharmacy or on the ward, from vial to any bag, ProSeal™ ADRx Devices offer a more advanced and simplified approach to medication transfer.

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ProSeal™ Vial Adaptors

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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