A leading biotechnology solutions provider based in California U.S. and operating globally.
A patient administered drug delivery device allows each user to “dial up” a dose and deliver it subcutaneously. Efficacy and user safety depend on every device being assembled correctly and each of several components having mechanical properties within tight specifications to guarantee the dose is accurate and correctly targeted. The challenge is to confirm these properties on fully assembled devices as they emerge from the manufacturing process.
A Risk Assessment by the customer had already identified the important factors in device function needing to be verified by end of line testing, but in drawing up a specification for an automated test system, our own FMEA revealed that each of these main factors depended on multiple parameters of the device all being in tolerance. By sharing this analysis with the customer we were able to agree a User Requirements Specification that fully defined all of the measurements required to confirm correct and in specification operation of the device
A simple to use inspection workstation incorporates five independent servo driven axes that together exercise all the mechanical components of the device to perform a mixture of static and dynamic force and torque profile measurements. In a test cycle of a few seconds, the machine measures 15 parameters and compares each with pre-set limits. If any one of these is out of range the item is signalled as faulty and is rejected.
The workstation meets the strict regulatory requirements applying to pharmaceutical products of this type, both in its design, its materials of construction, and in the level of documentation supplied covering functional and design specifications, test protocols, and operational manuals.