Volume (ml) per container (Table 2 of USP <71>)
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
Minimum number of units per medium for Sterility Test (Table 3 USP <71>)
This refers to the number of units we will need to sample product from, for each medium.
0 containers
USP 71Units required for sterility test: 0 containers
Volume needed for method suitability: 0 mL |
Rapid ScanRDIUnits required for sterility test: 0 containers
Volume needed for method suitability: 0 mL |
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.