OXFORD, England, January 24, 2022 – Owen Mumford Pharmaceutical Services, a division of Owen Mumford Ltd., announces that its UniSafe 1mL safety device for pre-filled syringes has been approved as a combination product in Asia. In Europe, regulatory approval has also been granted for UniSafe 1mL, and the product is now available on the market as a combination product with a drug for the treatment of rheumatoid arthritis.
UniSafe 1mL is a safety device for pre-filled syringes that offers a range of benefits to both pharmaceutical companies and their patients thanks to its unique, patented spring-free design. By being engineered without a spring, UniSafe 1mL reduces complexity and cost, and prevents the risk of pre-activation during transit, manufacturing, or when being removed from packaging. It is simple for patients to use, requiring no extra steps compared to a standard pre-filled syringe. Additionally, the plunger rod is designed so it cannot be pulled out when removing the needle shield or the device from packaging, which eliminates the risk of accidental drug spillage and maintains sterility.
The innovative design of UniSafe makes it easily adaptable for different fill volumes, giving flexibility to pharmaceutical companies managing drug candidates that need multiple doses for subcutaneous injection.
Alongside this announcement and as part of the UniSafe platform, UniSafe 2.25 is also fully industrialized and available. UniSafe 2.25 is created to meet the needs of the expanding biologic and biosimilar market, where subcutaneous injections over 1mL are often required. It is compatible with standard 2.25mL pre-filled syringes with either cropped or small round flanges. UniSafe 2.25 shares many of the same design features as the 1mL device and both are simple to use with the same injection method as a pre-filled syringe.
“The launch of our unique, patented springless design for the UniSafe platform marks another important milestone in our patient-focused innovation strategy,” said Michael Earl, Director, Owen Mumford Pharmaceutical Services. “Not only does our device look less intimidating to users, but removing the spring allows patients to clearly check for drug clarity before injection, while helping ensure the entire dose is delivered. There is also no risk of accidental pre-activation, giving customers peace of mind that there will be no leaking or wasted drug at any stage from shipment to administration. As part of our scale-up strategy for UniSafe, we have already invested significantly in multi-cavity tooling and full automation to meet expected demand for this platform.”
Both UniSafe 1mL and 2.25 offer the option of replacing colored finger flanges to allow for branding or to help distinguish between different drug doses. In addition, UniSafe 1mL can include extended finger flanges to support patients who have difficulty with dexterity or strength.