How much TOC is allowable in the water used to make up the One Reagent?
The One Reagent should be diluted for use in the QbD using water with <100ppb TOC. However, the actual amount of TOC may vary as each new bottle of diluted reagent is made up. The QbD1200 eliminates the measurement error that this may introduce by having a ‘Background Measurement’ feature, which should be used every time to allow the QbD1200 to determine the amount of TOC in the freshly made-up diluted reagent. It can be run again at any time if the user is concerned that the diluted reagent has been sitting in the bottle for a long time.