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Application note: A new, more flexible endotoxin test platform

This application note discusses some of the critical issues users experience with endotoxin testing around accuracy, flexibility, sustainability and platform cost.

The pillars of analytical testing can be said to include accuracy/precision, flexibility, sustainability (supply chain) and costs associated with a specific platform. Accuracy is important because it sets the foundation for ‘pass’ or ‘fail’ in terms of sample contamination and the lack of routine test precision also leads to expensive retesting. Flexibility is necessary to marry incoming test demand with routine laboratory capabilities in an efficient fashion. Sustainability is becoming increasingly critical due to supply chain failures that today remain under pressure after supply chain shocks have somewhat receded. Sustainability has also been referred to as a way of ‘future proofing’ a test platform. Costs inherent in a specific method among various available platforms are largely related to developing a laboratory process that is ‘fit for use’ for incoming manufacturing samples. Platform costs are largely inherent, but more users could benefit their company by keeping an eye on how expensive reagents are metered out on a test-to-test basis.

Here, we discuss some of the critical issues users experience with endotoxin testing that revolve around these topics.