When Suitability test for Sterility has to be repeated?

Microbiology
1

I would like to know if it is necessary to repeat the Suitability test for sterility when there is a change only of the type of sterisolutest (example TZHAMD210 instead of TZHASY210) for testing the same sample. I know that the Suitability has to be repeated when the test for sterility has to be carried out on a new product and whenever there is a change in the experimental conditions of the test.

Your feedback is really appreciated

2

@pbarzi when you change any equipment, you must qualify it before its use for analysis and the both sterisolutest used in sterility test for prefilled syringes, has a difference in their operation therefore, it should be qualified for its performance.