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.”
Nemera is a world leader in the design, development and manufacture of drug delivery devices for the pharmaceutical, biotechnology and generics industries. The company has an extensive product range that covers several key delivery routes: Ophthalmic, Nasal, Buccal, Auricular, Parenteral, Inhalation, Dermal and Transdermal applications. With comprehensive integrated services, Nemera offers a holistic approach and supports its customers from early-stage human factor studies and initial concepts to GMP-compliant manufacturing facilities.