An auto-injector is a medical device for administering liquid medications and is therefore subject to stringent quality control. Previously, parameters such as the firing time and duration of expulsion could only be measured manually. ZwickRoell has provided a solution for automated determination of actuation force, firing time, expulsion time and expulsion speed, together with the active-ingredient profile and the extended needle length.
zwickiLine materials testing machine applications are specifically tailored towards quality assurance and research. The smallest version of the machine, with a maximum force of up to 500N, is also suitable for multi-stage tests on auto-injectors or pen systems. Key features include a device for tests including safety functions and activation forces, together with sensors for measuring the delivery time for the liquid and the extended needle. Parameters such as firing time, expulsion time and the length of the extended needle are determined via two lasers.
Evaluation of all the data obtained is performed time-synchronously via the testXpert II testing software. Scales are additionally incorporated into the testing system to determine the amount of active ingredient delivered. This evaluation is also performed via testXpert II. A microphone for detection of activation noise can also be integrated into the system, as can a video camera for time-synchronous visual recording of the test.
Ever-increasing demands are placed on software used in the medical and pharmaceutical industries to document the traceability of completed actions. These demands are comfortably met by the 'Expanded Traceability' (as per FDA 21 CFR Part 11) option available for ZwickRoell's testXpert II testing software.
The testing system is also available with Qualification DQ, IQ and OQ included.