Sterility Test and Method Suitability Sample Quantity Calculator

Tuesday, March 5, 2024

Entered Type of Drug Product:  

Entered Unit fill volume (mL):  

Entered Number of units filled:  


Required for Sterility Test

This refers to the amount of product we will remove from each vial during testing. It is the amount from each unit that will go into TSB or FTM, or the amount from each unit that will be filtered per ScanRDI.

mL

This refers to the number of units we will need to sample product from, for each medium.

0 containers

USP 71

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0 mL

Rapid ScanRDI

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DISCLAIMER: This calculator has not been validated to compliance with 21CFR Part 11 and is offered as a quick estimation of what is needed. We recommend the user confirm the values against USP <71>. Atlas will confirm quantities upon receipt. The user assumes full responsibility.