Autoinjectors – A Multifaceted View on Critical to Mission Drug Devices from an Armed Forces Laboratory’s Perspective

On the battlefield, soldiers are exposed to various threats for instance wounding and toxins like chemical warfare agents (CWA). In both cases, they rely on immediate countermeasures by self-administering autoinjectors either to relief pain or counteract the effects of CWAs. Therefore, the reliability of the autoinjectors provided is critical to the soldiers’ morale and thus critical to mission success. Ensuring the highest quality standards is a core mission of the Bundeswehr Medical Service. Due to its unique skills profile, the Central Institute of the Bundeswehr Medical Service Munich (CIMS) has a genuinely multifaceted view on these drug devices. Its department for Pharmacy ensures the quality of procured marketed autoinjectors at the time when they enter the responsibility of the German Ministry of Defence amongst other duties. Since many drug device combinations (DDC) are purchased without expiry date, key physicochemical, microbiological and mechanical properties attributes are monitored during the whole time of stockpiling in the German Armed Forces (1). This provides decision-makers with the information base to decide on the compliance of these DDC with the civil protection exemption regulation to the German Medicinal Act (AMGZSAV). In recent years, the planned mass-production of autoinjectors by the Bundeswehr calls upon the department as the control laboratory according to the German Medicinal Products Act. From performing analyses regarding the quality of ready-to-fill syringes to conducting and evaluating stability testing for formulation candidates according to ICH-guidelines. The expertise of the CIMS is in high demand even in the pre-production phase (1; 2). In addition, its scientific prowess is held high by repeated publications in peer-reviewed journals especially on the topic of autoinjector devices (3) and suitable drug candidates (4). To perform its duties, the CIMS is using a variety of scientific methods from covering basic pharmacopoeial testing (pH, visible particles, etc.), self-developed and validated chromatographic procedures all the way to using unique machines designed for mechanical autoinjector testing, while keeping the high standards of an ISO 17025 control laboratory.