Unilife Completes Validation Tests

Retractable syringes maker Unilife Corporation ( UNIS - Snapshot Report ) has successfully completed all the required validation tests for its Unifill ready-to-fill (prefilled) syringe, representing the final step in the industrialization process of this unique device.

The achievement underscores that the Unifill syringe is fully compliant with all major regulatory requirements and meets the company’s own standards for device quality, reliability and functionality.

Unilife began initial production of the Unifill syringe at its FDA-approved plant located in York, Pennsylvania, in late March 2011. The company is currently in the process of negotiating with more than 20 pharmaceutical companies who have shown interest in its syringe.

It is anticipated that these pharmaceutical makers will buy from the early production lots, in order to conduct their own formal appraisal of the Unifill syringe in combination with their injectable drugs or vaccines. The completion of the product verification and validation phase opens the way for the product to be shipped to these customers. Unilife plans to commence initial sales in the near future.

Prefilled syringes act as the main drug container for about 50 injectable vaccines and drugs that are marketed by over 20 pharmaceutical companies. Unilife is of the opinion that the pharma market for prefilled syringes is the fastest-growing, relatively uncongested and the most lucrative segment of the global syringes industry.

The first-of-its-kind Unifill syringe is expected to revolutionize the $2.7 billion devices market for prefilled syringes as it is way ahead of the currently available prefilled syringes.

Pennsylvania-based Unilife is a medical devices company that designs, manufactures and sells advanced drug delivery systems. It collaborates with biotech and pharmaceutical companies and explores new devices that could be used with their drugs.

The company has developed a wide array of its own injectable drug delivery products, including retractable syringes. It sells its prefilled syringes to pharmaceutical manufacturers, suppliers of medical products to healthcare facilities and patients who self-administer prescription drugs.

Unilife’s patented syringes provide integrated safety, which is designed to protect patients from needle stick injuries. The company competes with Becton, Dickinson and Company ( BDX - Analyst Report ) among others.