ProSeal™ Bag Adaptor

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

Versatile Conversion

With the ProSeal™ Bag Adaptor, most standard fluid bags can be easily converted into Closed System Bags, enhancing medication safety.

Closed-System Medication Transfer

When connected to the inlet port of an IV bag and engaged with the ProSeal™ Injector, it facilitates secure, closed-system drug transfer into the IV Bag.

Dry Connection Assurance

This patented mechanism securely attaches to the inlet port of any standard fluid bag, maintaining a dry connection during medication administration or withdrawal.

Efficient IV Bag Access

The ProSeal™ Bag Adaptor provides access to an IV Bag through the medication port, ensuring efficient drug administration.

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.