System Suitability Tests
Altus Science is a Certified Reference Material (CRM) provider, focusing on Total Organic Carbon (TOC), providing System Suitability Tests for all makes of TOC analysers. A full list of products available can be found here.
The validity of analytical data is based on the measurement system as a whole, consisting of:
• Competent and well-trained personnel
• Adherence to a standard operating procedures
• Validated and well-serviced instruments
• Certified reference materials
The suitability of the analyzer is determined by testing a certified blank and certified reference solutions of both 0.5 mg C/L sucrose, and 0.5 mg C/L of 1,4-benzoquinone. The response efficiency is then calculated, and the system is determined to be suitable if the response lies between 85% and 115%.
USP specifications do not explain how often the system suitability test should be performed. Therefore the frequency needs to be established considering the risk associated with the system being out of tolerance, and the cost to demonstrate that the system is within tolerance.
Initially we recommend performing SST on a frequent basis, and typically customers choose to run an SST daily or weekly for a certain period. This period is used to establish and evaluate performance and control limits. After the data has been collected and statistically analysed, the appropriate SST frequency can be determined.
Internally prepared standards, used for routine quality control, cannot replace the periodically required system suitability tests. We recommend periodic use of an externally supplied, certified reference material for SST purposes.