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Passive Safety Device—Assessing The Impact On Drug Dose Delivery: A Nemera White Paper

Summary:

Historically, injectable drugs are contained in vials and administered in healthcare facilities by professionals. But with an increasing trend towards self-administration and at-home administration, prefilled syringes (PFS) has emerged in the early 2000's. The growing popularity of PFS is due to its ease of use, facilitating the injection process and reducing the total injections steps, but also the improved user safety and the reduction of dosage errors. It is also linked to their cost efficient profile not requiring as much drug overfilling as vials (up to 25% for vials).

The objective of this white paper is to compare the non-injected volume between three marketed passive safety devices for 1ml PFS after simulated injection performed by non-healthcare and healthcare professionals.

Overview:

In the parenteral industry, needlestick injuries remain a global concern. According to the World Health Organization, over 3 million exposures to blood occur every year, resulting in health, psychological and cost issues. Safety devices for prefilled syringes have been developed to aid in the protection of users from needlestick injuries. Safety devices are classified in two categories: passive if the safety feature automatically activates at the end of the injection without any additional gesture from the user; active if the user needs to perform an additional gesture to trigger the safety feature once the injection completed.

Nemera has developed Safe'n'Sound® (figure 1), a platform of passive safety device for prefilled syringes which not only aid in the protection from accidental needlestick injuries, but was also designed to optimize drug dose delivery (consistency of drug dosing) thanks to a patented mechanism. Design optimization of these output parameters is key for pharmaceutical companies as they have an impact on treatment efficiency and drug overfilling.

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