UniSafe® In Patient Use

Our novel UniSafe® 1mL spring free safety device for prefilled syringes has reached a significant milestone and we are pleased to announce it is now being used in Indonesia for treating hospitalised patients with COVID-19 infections. The on-market device contains Fondaparinux, a synthetic anticoagulant chemically similar to low molecular weight heparin, which is indicated as prophylaxis for venous thromboembolism which can occur as a result of severe COVID-19 infections[1].

In Europe UniSafe 1mL is now also approved and being used for patients who require treatment with methotrexate, a drug typically used to treat rheumatoid arthritis and Crohn’s disease. The design of UniSafe 1mL syringe allows it to be used for multiple fill volumes up to 1mL which is of particular benefit for methotrexate where doses are patient specific and are also dependant on the stage of the particular disease. The availability of a range of coloured finger flanges for UniSafe also helps with distinguishing different drug doses.

UniSafe is unique in that, unlike other safety devices on the market, it does not contain a spring to retract the needle after drug administration. This has the advantage of reducing the risk of pre-activation in transit or before use, plus also ensures that final assembly of the device is simple for the pharmaceutical company or their contact manufacturer. Needle protection is of course key in adhering to the various guidelines around the world for the prevention of needlestick injuries to healthcare professionals, patients, and their carers.

Another key safety aspect in the UniSafe design is the secure integrated plunger which helps to prevent removal and potential drug spillage and wastage prior to use. In addition, the plunger design also helps to prevent re-use and provides tamper evidence. The smooth integrated plunger is also designed for patient comfort and to facilitate controlled delivery during drug administration which is achieved using the same simple technique as a normal syringe. The UniSafe optional extended finger flange also aids the medication delivery process for those patients with dexterity challenges.

At Owen Mumford we have been making significant investments in UniSafe and have installed new high volume automated assembly equipment in one of our UK plants. At the same time, we have commenced construction on our new manufacturing facility in Witney, UK. This site, once completed, will house the UniSafe equipment and become a centre of excellence for automation and assembly and allow production of multiple millions of sub-assemblies. The Witney site is being built to align with our sustainability agenda and goals and will designed in accordance with the latest environmental standards in order to obtain BREEAM certification. The site will employ energy efficient technology, have EV charging points available and promote biodiversity, all to help support our B Corp certification and Science-Based Targets initiatives.

As part of the UniSafe platform in 2021 we launched UniSafe 2.25. Based on UniSafe 1ml the 2.25 version is designed for delivery of higher volume and higher value biologics which are becoming more prevalent. UniSafe 2.25 is also designed to handle the higher viscosity formulations typically found with biologics.

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