Owen Mumford Pharmaceutical Services, a division of Owen Mumford, has announced its UniSafe 1 mL 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 1 mL and the product is now available on market as a combination product with a drug for treatment of rheumatoid arthritis.
UniSafe 1 mL is a safety device for prefilled syringes, engineered without a spring to reduce complexity and cost, as well as the risk of pre-activation in transit, during manufacturing or the removal from packaging. The device is used the same way as a conventional pre-filled syringe with no additional steps. The plunger rod has an integrated design so that it cannot be pulled out when removing the needle shield or the device from its packaging, eliminating the risk of accidental drug spillage and compromised sterility.
The product’s design allows it to be tailored to different fill volumes, providing flexibility for those pharmaceutical companies who have drug candidates with multiple doses required for subcutaneous injection.
The company has recently announced an extension to the product platform, UniSafe 2.25, designed to meet the needs of the growing biologic and biosimilar market, where subcutaneous injections of volumes above 1 mL are often required. It is compatible with standard 2.25 mL prefilled syringes with both cropped and small round flanges.
“The launch of our unique, patented springless design for the UniSafe platform is another milestone in our patient-centric innovation strategy,” said Michael Earl, Director, Owen Mumford Pharmaceutical Services. “Not only does our device look less intimidating for users, but the absence of a spring means that patients have complete visibility to check for drug clarity prior to injecting, while also ensuring the full dose has been delivered. There is also no risk of accidental pre-activation, giving our customers peace of mind that there will be no drug leakage or waste at any stage from dispatch to administration of the medication. As part of our scale up strategy for UniSafe we have already made significant investments in multi-cavity tooling and fully automated assembly to be able to deal with the anticipated demand for this platform.”