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Unilife Corporation

Unifill Ready-to-Fill (Prefilled) Syringe

The Unifill ready-to-fill (prefilled) syringe is the world’s first and only known prefilled syringe with automatic safety features fully integrated within the glass barrel. It is a primary drug container, a safety device and a needle containment system all rolled into one. The Unifill syringe is supplied as per standard handling systems for integration into fill-finish systems used for equivalent conventional prefilled syringes. Compared to ancillary safety products attached onto prefilled syringes, Unifill can help streamline fill-fill systems and significantly reduce transport, packaging, and storage costs. USP Class Six compliant materials reside within the drug-fluid path.

The Unifill syringe is designed for safe, simple, and convenient use by either healthcare workers or patients who self-administer prescription medication. An audible, tactile click signals the injection of the full dose and the automatic activation of a needle retraction mechanism. Operators can control the speed of needle retraction directly from the body into the barrel of the syringe. The combination of automatic, operator-controlled retraction features within the Unifill syringe can help to virtually eliminate the risk of infection from needlestick injuries. The plunger is automatically locked after needle retraction, to prevent re-use of the device, circumvent product tampering, and encourage convenient and compact disposal. The Unifill syringe is now in production at Unilife’s production facilities in York, Pennsylvania, and available for supply to interested pharmaceutical parties for evaluation.

Fill-Finish Integration

The Unifill syringe is supplied as per standard handling systems for integration into fill-finish systems used with equivalent ready-to-fill syringes. The Unifill syringe was designed to comply with standard processes used to fill, finish, and package conventional prefilled syringes with a measured liquid dose of up to 1mL in volume. Pharmaceutical customers receive the Unifill syringe in three sterile sub-assembly packaging configurations. The glass barrel sub-assembly configuration is supplied in a tub-and-tray system containing 160 units, with a loose Tyvek sheet and a Tyvek sealed lid. Unilife supplies plunger seals in an isolator port bag, and plunger sub-assemblies in a sealed plastic bag. Unilife is able to tailor its packaging configurations to meet specific customer needs. As a primary drug container that is similar in size to standard products, Unifill syringes can eliminate the costs and inefficiencies incurred by purchasing ancillary safety products that are attached onto standard prefilled syringes to comply with needlestick prevention laws.

Drug Stability

The Unifill syringe is a primary drug container designed for compatibility and stability with target prefilled injectable drugs and vaccines. Components within the drug fluid path are USP Class VI–compliant and tungsten-free. Unilife maintains relationships with many established material suppliers of ready-to-fill glass barrels, vials, and ampoules. To support customer branding preferences, many of our components can also be customized or supplied in various colors. For additional information regarding Unilife material selection options or to receive the Unifill syringe for compatibility and stability testing, please contact us at This e-mail address is being protected from spam bots, you need JavaScript enabled to view it .

Integrated Safety

The Unifill syringe is designed for intuitive use by either healthcare workers or patients, and offers compact handling, optimal protection, and convenient disposal. To virtually eliminate the risk of infection associated with potential blood-borne virus transmission modes such as needlestick injuries or aerosolization (splatter), the Unifill syringe incorporates an automatic (passive) safety mechanism that is fully integrated within the device. An audible, tactile click serves as a reliable end-of-dose indicator and a signal that the needle retraction mechanism has been activated. Operators can control the speed at which the needle is retracted from the body into the barrel by relieving thumb or finger pressure on the plunger. Upon the full withdrawal of the needle into the barrel, the plunger is automatically locked to prevent needle re-exposure, device re-use, or product tampering. Unifill syringes offer far more than compliance with needlestick prevention laws. They are designed to help to streamline injection procedures within healthcare facilities, improve patient compliance with therapy, and provide optimal protection to both the operator and others at risk of needlestick injuries. Such benefits can help to reduce healthcare costs and directly impact the commercial success and overall value of the drug-device combination product.

Brand Differentiation

The Unifill syringe sits at the leading edge of a unique technology platform of ready-to-ffill safety syringes developed by Unilife to protect healthcare workers, improve patient care, and optimize drug product lifecycles. The Unifill syringe is highly differentiated from ancillary safety products that are attached onto a standard prefilled syringe either by the pharmaceutical manufacturer or the operator. Such clip-on safety products can increase the bulk of a prefilled syringe by up to 60 to 70%, reducing its portability and capacity for compact handling by an operator. Some ancillary safety products also require an operator to undertake additional or non-intuitive steps of use during the injection of the dose or the activation of the safety mechanism. The Unifill syringe is intuitive for use by either healthcare workers or patients. Researchers conducting independent comparative evaluations of the Unifill syringe and leading ancillary safety products found that users strongly preferred Unifill for performance, intuitive use, safety, and design. Pharmaceutical companies can utilize the strengths of the Unifill syringe to help generate powerful brand differentiation for their brand-name, generic, or biosimilar drugs within competitive therapeutic markets to optimize product lifecycles and increase market share.

Key Features
  • Fill-Finish Line Integration: Unifill syringes are supplied per standard handling processes for integration into the fill-finish systems used with equivalent standard (non-safety) ready-to-fill syringes.
  • USP-Compliant Materials: Unifill syringes feature USP Class VI–compliant materials inside the drug fluid path and are tungsten-free to support compatibility and stability studies with target molecules.
  • Compact Handling, Intuitive Use: Unifill syringes are a similar size to equivalent standard prefilled syringes for portable transportation, convenient handling, and compact disposal, and share similar steps of use to maximize compliance with routine injection procedures.
  • True End-of-Dose Indicator: An audible, tactile click signals the injection of the full dose and the activation of the safety mechanism, enabling the operator to focus on the delivery of optimal care to the patient or themselves.
  • Passive Safety Activation: The passive (automatic) activation of the needle retraction mechanism upon the delivery of the full dose can virtually eliminate the risk of needlestick injury, as the non-sterile needle need never come into contact with the open air.
  • User-Controlled Retraction: Operators can control the speed at which the needle is retracted directly from the body into the barrel of the syringe by relieving thumb or finger pressure on the plunger, to avoid other potential infection risks, including aerosolization (splatter).
  • Needle Containment System: Upon the full withdrawal of the needle into the barrel, the plunger is automatically locked in place to prevent any risk of device re-use, product tampering, or needle re-exposure. The device can be conveniently discarded per recommended procedures.
  • Fully Integrated Safety: All safety features are fully integrated within the glass barrel to facilitate compact handling, accurate dose delivery, engagement of the safety mechanism, and convenient disposal.
  • Customization: Unifill syringes can be fully customized to meet the specific requirements of the pharmaceutical customer and the patient. Options include extendable finger flanges for improved operator handling, a selection of materials and elastomer coatings for select components plus other customizations such as color configurations
 
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