ProSeal™ Vial Adaptors
Complete Containment
ProSeal™ vial adaptors are equipped with concave spikes, ensuring that once they pierce the concave vial stoppers, medication remains fully contained within the vial. No more wastage and contamination.
Advanced Filtration
Featuring a sterile 0.1-micron filter and an activated carbon filter, ProSeal™ vial adaptors provide an added layer of protection, reducing the risk of contamination and enhancing medication safety.
One-Way Valve
With an integrated one-way valve, ProSeal™ ™ Vial Adaptors offer hands-free, automatic pressure equalization, eliminating the need to introduce air into the vial before withdrawing its contents.
Time-Saving
Thanks to the streamlined medication withdrawal process, valuable time is saved, and a focus on what truly matters is gained – patient care.
With or Without External Balloon
Available in both non-DMA and DMA compatible versions, suitable for 13mm, 20mm, and 28mm vial neck sizes.
User Friendly
Designed for easy and efficient operation, ProSeal™ vial adaptors ensure user-friendly pressure equalization, simplifying the medication administration process.
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™ 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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The ProSeal™ range of closed system accessories offer user-friendly and effective solutions to enhance current clinical practices.
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