Today, according to the WHO, around 16 bil­lion injec­tions are admin­is­tered annu­ally. But this involves risks: Every year, needle­stick injuries result in thou­sands of infec­tions with dis­eases such as HIV and hepatitis C. This pri­marily affects health­care workers. In addi­tion, the number of injec­tions admin­is­tered by patients them­selves is increasing – inex­pe­ri­enced users are exposed to an increased risk of injury. As a result, reg­u­la­tory bodies have estab­lished reg­u­la­tions and rec­om­men­da­tions to pre­vent needle­stick injuries and to increase the safety of end users.

Ergonomic and robust pas­sive safety device

With this in mind, Nemera designed and devel­oped its pre­mium add-on pas­sive safety device Safe’n’Sound® on the basis of human factor studies. The device is com­pat­ible with pre­filled syringes with a filling volume of 1 ml or 2.25 ml according to ISO stan­dard. In addi­tion it ensures that the needle auto­mat­i­cally springs back into the pro­tec­tive cover after injec­tion, thus reli­ably pre­venting needle­stick injuries. “Right from the start, Safe’n’Sound^® was devel­oped with the user in mind and with a focus on meeting the patient’s needs,” explains Séverine Duband, Global Cat­e­gory Man­ager Par­enteral. “Based on exten­sive studies, we have devel­oped a robust and ergonomic design that pro­vides both safety and con­ve­nient use for in­experienced users and health­care professionals.”

“Safe’n’Sound^® pro­vides both safety and con­ve­nient use for inex­pe­ri­enced users and health­care pro­fes­sionals.”Séverine Duband, Global Cat­e­gory Man­ager at Nemera

Espe­cially in the early stages of a project, Harro Höfliger’s Assembly Lab is ide­ally suited for assem­bling the pre­filled syringes with the indi­vidual parts of the safety device. Crit­ical processes such as screwing the plunger stopper into the thread of the stopper – two impor­tant com­po­nents of the device – are car­ried out reli­ably by the semi-auto­matic machine. In order to main­tain the sterile bar­rier, a very pre­cise screwing unit con­trols the assembly process of the plunger rod into the stopper.

One plat­form – many devices

All crit­ical processes can be trans­ferred equiv­a­lently to fully auto­mated pro­duc­tion machines; thus the Assembly Lab cre­ates a per­fect basis for suc­cessful scale-up. It is also suit­able for devel­op­ment pur­poses: After quick and simple retro­fitting, it is not only pos­sible to switch between the pro­cessing of syringes with a filling volume of 1 ml or 2.25 ml but, within a few min­utes, other devices such as autoin­jec­tors or pens can also be assem­bled on one and the same platform.

“Thanks to our col­lab­o­ra­tion with Harro Höfliger, we offer our cus­tomers process reli­a­bility and the pos­si­bility to safely scale the pro­duc­tion.”Audrey Chandra, Cat­e­gory Man­ager Par­enteral at Nemera

Audrey Chandra, Cat­e­gory Man­ager Par­enteral, is pleased that the coop­er­a­tion with Harro Höfliger enables Nemera to pro­vide phar­ma­ceu­tical com­pa­nies with inte­grated turnkey solu­tions: “Safe’n’Sound^® is a whole-in-one product that focuses on patient safety and growing market needs. Thanks to our col­lab­o­ra­tion with Harro Höfliger, we offer our cus­tomers process reli­a­bility and the pos­si­bility to safely scale the pro­duc­tion of their drug-delivery com­bi­na­tion product.”

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Photos: Nemera