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End-to-end development and manufacturing for an innovative IV bag.
Sanner led full development, design transfer, and high-volume serial production of the SmartSite™ Bag for BD, an empty IV bag that can be filled, disinfected, and accessed again to add medications.
Clinicians need empty IV bags in roughly one out of every four preparations. BD required a partner who could take the SmartSite™ Bag from design through regulatory clearance and into high-volume serial production, then scale manufacturing as demand grew.
Sanner took responsibility for bag design, the supply chain for the complete product, and the design and validation of the manufacturing process. Sanner also managed the 510(k) and CE Mark submissions through to clearance and holds the 510(k).
When demand reached high volumes, production was transferred to our Tijuana, Mexico facility, a complete site-to-site transfer and validation executed in three months from first equipment received to first truck shipped. The Tijuana line combines solvent bonding, automated bagging, vision system inspection, and leak testing, with installed capacity of 15,000 units per shift against annual demand of 750,000 units. Finished product is gamma sterilized in Ontario, California and delivered directly to BD’s distribution center in Redlands.
The BD SmartSite™ Bag addresses the need for empty IV bags, which occurs in approximately one out of every four preparations. The SmartSite™ Needle-free Valve enables BD SmartSite™ Bags to be filled with IV solution, disinfected and accessed again to add medications.
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