Table 5.
Laboratory tests of FDKs and the PCS.
| Test code | Container | Conditions | Observations | Microbiological Results | |
|---|---|---|---|---|---|
| Test a | 2.5-gal bag | - 15 g Part A | Reaction in 2:20 | Sterilizeda,b | |
| - 4 g Part B | RH >96.4% | ||||
| - 30 mL H2O (tap) | T = 30°C | ||||
| in a 100 mL beaker | [ClO2] >7000 ppm | ||||
| Test h | 10-gal bag | - 15g Part A | Reaction at 2:10 | Sterilizeda,b | |
| - 4 g Part B | RH >74% | ||||
| - 30 mL H2O (tap) | T = 25.4°C | ||||
| in a 100 mL beaker | |||||
| Test i | PCS | - 16 g Part A | Reaction in 2:30 | Sterilizeda,b | |
| - 4 g Part B | RH >96.2% | ||||
| - 30 mL H2O (tap) | T = 24.4°C | ||||
| in a 100 mL beaker | [ClO2] >7000 ppm | ||||
| Test n | PCS | - 15g Part A | Reaction at 2:12 | Sterilizeda,b | |
| - 4 g Part B | RH >93.5% | ||||
| - 30 mL H2O (tap) | [ClO2] >7000 ppm | ||||
| in a 100 mL beaker | Run time 15 min |
a,bSterility confirmed with G. stearothermophilus and B. atrophaeus bio-indicators, respectively.