Understanding Your Process Reliability: Compliance Considerations For Emergency-Use Delivery Systems

By Richard Motruk, Chief Operating Officer, Kymanox Corporation, Morrisville, North Carolina, and Nathan Blazei, Head of Quality, Kymanox Corporation, Morrisville, North Carolina

Historically, auto-injectors have been the predominant method of delivery for therapeutics involved in emergency-use scenarios (e.g., epinephrine, naloxone, and similar). Auto-injectors are designed for self-administration, whereby patients have the convenience of receiving the injections in a non-clinical setting (e.g., home or office). Since auto-injectors automatically carry out the injection cycle once actuated, patient compliance is improved compared to manual delivery devices, such as syringes. This capability is particularly important for emergency treatments, as an auto-injector can reliably administer the necessary dose in high pressure situations, whereas more manual delivery devices could be prone to user error and lead to drastic outcomes for the patient. Because auto-injectors are typically the delivery device of choice for emergency medications, they come with increased scrutiny from regulatory bodies regarding their safety and effectiveness.

This article reviews the FDA reliability requirement for auto-injectors and how to overcome the significant challenge for developers and manufacturers to meet compliance requirements.