Phase A: QC vial
To streamline things, BactoBox® both tunes and qualifies the setup simultaneously here in phase A
In practice, the QC test program implements most of phase A. However, there is a manual check against the certificate of analysis at the end. Be aware of that!
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Get things ready
You need these items:
1 × clean BactoBox® setup (see Clean the setup)
1 × QC vial (see Make QC vial)
1 × certificate of analysis for the QC vial
Clean the BactoBox® setup first
Make sure that you use a clean BactoBox® setup. See Clean the setup.
Step by step
Start the QC test program
We do so with three button presses.
Enter the Programs menu
First, press and hold Measure until the Programs menu appears.
Enter the QC test screen
Second, press Measure again briefly to select the QC test program.
Start the QC test program
If the user interface highlights "Clean first" then stop here. Follow the guide in Clean the setup and come back here when you are ready.
Third, press Measure again briefly to start the QC test program.
After the final button press, BactoBox® starts the tune and qualify procedure.
Check the certificate of analysis
Wait for the QC test program to complete. Read the total/ml concentration.
See also Example A.
Qualification: Phase A passes
The total/ml is within ±15 % of the value found in the certificate of analysis.
Qualification: Phase A fails
If any error occurs, or, if the total/ml is outside the requirements listed above.
See Phase A: QC vial fails for a troubleshooting guide.
Examples
The check the certificate of analysis step is a bit complex. Therefore, we provide a couple of examples below to help you along the way.
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