A pharmaceutical organization brought in Kymanox® to ensure its reliability protocols met new FDA requirements for two autoinjector products.

In the last few years, emergency use devices have come under increased scrutiny with FDA mandating these devices demonstrate reliability to a higher standard. These heighted reliability thresholds posed challenges to the client because their traditional statistical sampling/acceptance strategies were not sufficiently powerful and simply adding increased sampling became logistically impractical.

In addition to the empirical data generated through a reliability protocol, the FDA also mandated that the entire system from the component dimension level all the way through product distribution, be modeled through a Fault Tree Analysis (FTA). The industry is well versed at utilizing failure modes effects analysis (FMEAs) and Manufacturing Control Plans to evaluate and mitigate risk. These approaches are very adept at evaluating each individual risk independently but fall short at understanding the accumulated risk of the entire system. The FTAs are much better at evaluating the entire system, and this is why the FDA is requiring the use of the risk assessment tool as part of the reliability package for emergency use devices.

Kymanox was responsible for identifying technical considerations for the pre-conditioning of the samples subjected to the reliability testing, providing statistical expertise around sampling and acceptance criteria development, and executing the fault tree analysis to support the client’s product reliability claims.

Kymanox collaborated with and educated the clients contract manufacturer organizations (CMOs) as well as their third-party suppliers

Challenge

Meeting more stringent FDA guidelines that are hard to demonstrate and require statistical expertise

Solution

Kymanox subject matter experts provided strategy, technology, and ultimately received approval of multiple reliability protocol reports.

Results

Kymanox developed a novel testing strategy and statistical sampling techniques, as well as the client’s first fault tree analyses (FTAs). The FTAs builds from the device component/dimension level, through the inspection and manufacturing process, utilizing boolean logic (probability statistics) to evaluate the overall risk of the system.

Kymanox also created strategies for estimating false acceptance rates of 100% automated inspections (vital piece of the fault tree analysis and demonstrating your reliability).

These contributions resulted in the approval of two reliability protocol reports that met the newly established FDA guidelines for both of the client’s autoinjector products.