10 August 2023
Challenges in comparing breaking force test results.
Two measurement principles are described in the US Pharmacopeia <1217>: Constant speed ≤ 3.5mm/s or linear force ≤ 20N/s. But comparability is only guaranteed when tests are performed under identical conditions.
While many modern hardness testers - sometimes also referred to as tablet breaking force testers or resistance to crushing strength testers - allow to change the setting of the measuring principle (e.g. to different speeds or different force increases), older devices often lack corresponding documentation or the possibility to save product-specific settings. To be able to compare data gathered from different testers, however, it must be ensured that the instruments apply force to the tablet in a similar manner. Different settings of the measuring principle typically lead to significantly higher or lower results.
Additionally, repeatable positioning and alignment of the dosage form are also essential for both manual and automated testers. Variations in tablet alignment will inevitably lead to variations in test results.
In this respect, SOTAX offers a consistent family of hardness testers, from manual, semi-automatic to fully automatic testers that can also be integrated online with a tablet press for self-adjustment of compression parameters during manufacturing. The comparability of hardness measurement results (across departments in the laboratory and in production) is then no longer an issue as all testers are built on the same key components and allow to save product-specific settings if needed.
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