What sample size is required for cleaning validation of medical devices?

For cleaning validation, the complexity of the device's structural design and the reproducibility of the test data determine the sample size for testing.

The more challenging the cleaning process, the larger the sample size for the test. Typically, a validation test requires three, six, or nine instruments, depending on the complexity of the instrument structure.

The sample volume under test is considered sufficient if the following three conditions are met:

(1) There are at least 3 data for each analyte to be tested

(2) All data are within acceptable indicators of cleaning effectiveness

(3) The data with the largest value plus the standard deviation of the data does not exceed the acceptable indicators of cleaning effectiveness

At the same time, it is important to Consider the positive and negative control samples used during the test. We recommend going to Tacteasy, a medical device CRO, which is more efficient.