Non-destructive CCI Testing of assembled auto-injectors
To date, the Container Closure Integrity Testing (CCIT) of auto-injectors has been done using destructive sample testing. The assemblies to be tested are taken apart and the syringe within is inspected and leak tested using traditional methods. CCIT is our non-destructive leak testing application. Here, the methods as well as the results of our non-destructive leak (CCI) testing of a customer‘s autoinjectors, with a variety of fill levels and headspace volumes, is explained.
In order to verify the stability of the aseptically filled pre-filled syringe (PFS) or cartridge in assembled medical devices, leak tests are performed frequently. The container closure integrity (CCI) system has to be performed on the complete assembled device. Potential leakages can compromise the entire product development.
Probabilistic test methods e.g. Dye Ingress, require a disassembly of the medical device. This disassembling process adds to the dangers of introducing risks due to operator failure.
For some device types, a controlled and non-destructive disassembly is not applicable and requires additional steps, excessive effort or even the activation of the device to gain access to the primary container.
This step requires even more time and adds the risk of introducing defects that may even lead to false results and false rejects respectively.
- Our customers approach us typically in phase 3 of development. At this point, we need to understand the behavior of the auto-injector components under the influence of the vacuum decay’s testing pressure of 5 mbar absolute. When the syringe or cartridge is exposed to this vacuum level, the headspace will expand, moving the stopper outwards towards the non-sterile area. This movement creates an additional vacuum level within the barrel.
- The headspace expansion under the vacuum level will depend on the headspace volume available in the auto-injector arrangement. With a leak in the headspace, it may be possible that the differential pressure generated between the headspace and the volume around the primary container syringe is not sufficient for detection. Therefore, the influence of the headspace volume on the vacuum decay technology (LFC method®) is also analyzed.
The engineering and method development studies result typically in the vacuum decay technology (LFC method®) that can test complex auto-injector products with given preconditions - minor expansion of headspace. The sensitivity of both headspace and product leak is qualified with the mass spectrometry method as a cross-reference.
«Disassembly of our auto-injector design is very challenging. Therefore, we are looking into non-destructive approaches as well.»
Amisha Nair / Dermira
- Disassembly of the device is not necessary for leak testing
- Significant time reduction with non-destructive auto-injector leak detection
- Operator independent results
- Semi-automated inspection with quantitative data record