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UniSafe In Patient Use

Our innovative UniSafe 1mL spring-free safety device for prefilled syringes has achieved a major milestone, and we are excited to announce that it’s now being used in Indonesia to treat hospitalized patients with COVID-19 infections. The device currently in use contains Fondaparinux, a synthetic anticoagulant that’s chemically similar to low molecular weight heparin and is indicated as a preventive treatment for venous thromboembolism, a potential complication of severe COVID-19 infections1.

APRIL 2022
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In Europe, UniSafe 1mL is now also approved and being used for patients who need treatment with methotrexate, a drug commonly prescribed for rheumatoid arthritis and Crohn’s disease. The UniSafe 1mL syringe is designed to allow for multiple fill volumes up to 1mL, which is especially helpful when dosing methotrexate, as doses are tailored to each patient and depend on the stage of their disease. The availability of different colored finger flanges for UniSafe also makes it easier to identify different drug doses.

UniSafe stands out from other safety devices on the market because it does not use a spring to retract the needle after drug administration. This lowers the risk of accidental pre-activation during shipping or before use, and also means the final device assembly is straightforward for the pharmaceutical company or contract manufacturer. Protecting against needle sticks is crucial for meeting safety guidelines worldwide that aim to prevent injuries to healthcare professionals, patients, and caregivers.

Another key safety feature of the UniSafe design is its secure, integrated plunger, which helps prevent removal and possible drug spillage or waste before use. The plunger’s design also discourages reuse and shows evidence of tampering. The smooth, integrated plunger is made for patient comfort and allows for controlled medication delivery, using the same simple technique as a standard syringe. For patients with limited dexterity, the optional extended finger flange on UniSafe makes it even easier to deliver medication.

At Owen Mumford, we’ve made major investments in UniSafe, including installing a new, high-volume automated assembly line at one of our UK facilities. Meanwhile, we’re constructing a brand-new manufacturing plant in Witney, UK. Once complete, this location will house UniSafe equipment, serve as a hub for automation and assembly, and enable production of many millions of sub-assemblies. We’re building the Witney site with our sustainability goals in mind, following the latest environmental standards to achieve BREEAM certification. The facility will use energy-efficient technologies, have EV charging stations, and support biodiversity, all of which help us meet our B Corp certification and Science-Based Targets initiatives.

As part of the UniSafe platform, we launched UniSafe 2.25 in 2021. Built on the UniSafe 1mL platform, the 2.25 version is intended for administering higher-volume, higher-value biologics, which are growing in use. UniSafe 2.25 is also made to handle the thicker viscosity formulations often found with biologics.

References

  • 1. J Cardiovasc Pharmacol. 2020 Oct;76(4):369-371

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