Sartorius DocuClip & DocuMeter pH

1. Sartorius DocuClip & DocuMeterpH The new standard for reliability in electrochemical analysis

2. Transmission of measuring signal Display of cal-culated pH value pH measurement: Generating and documenting data Origin of measuring signal Evaluation of signals pH meter pH electrodes 1, 2, 3, ... The way how to evaluate the signal is called calibration or standardization This procedure is stored in the meter and will be used with all other electrodes until a new calibration has been taken

3. pH measurement: gaps in documentation Examples of GLP-compliant documentation today ------------------------ SARTORIUS Std. data 13-12-2004 13:48:31 Model PP-25 Serial No. 12143916 ------------------------ Channel A: pH mode Std interval off 4.01 pH 13-12-2004 13:48:31 98.79% (58.45 mV/pH) 7.00 pH 13-12-2004 13:47:09 Standardization ok. Name: Documentation of equipment : meter model: meter serial number, : meter software version : date / time of standardization and measurements but What about the electrode? No documentation : of electrode serial number : that calibration base and measured value have been evaluated with the identical electrode

4. Transmission of raw measuring signal Display of cal-culated pH value Sending this information back to the meter … along with ID information Sending back the information how to evaluate the raw signal What is needed to complete the documentation of a pH system? Origin of measuring signal Evaluation of signals Storing this specific infor-mation in the individual electrode and pH meter

5. The expected solution: An electrode with built-in memory Problems — An electrode with built-in memory chip needs a special data cable and a special plug and socket — Standard electrodes cannot be used with such a pH meter — There is no flexibility in choice of electrode manufacturer or type — For new electrode types new SOPs or even new validations are needed — Higher electrode costs

6. The new Sartorius approach A memory attached to the electrode cable DocuClip — Memory physically fixed at the cable — Non detachable — Stores calibration data, serial no., calibration history — Makes any electrode smart — Belonging DocuMeter also works with common electrodes

7. Documeter and Docuclip: gaps in documentation closed GLP-compliant documentation Documentation now includes : model and serial number of electrodes : nominal buffer values : raw signal of standardization (mV) : initial standardization : standardization history : relation of measured values to the underlying standardization

8. pH measurement: gaps in documentation closed Examples of GLP-compliant documentation today Documentation of equipment and electrodeincluding : model ID and serial number : date and time of standardi- zation and measurement : measured value is related to the underlying standardization data

9. DocuMeter & DocuClipDocuClip initially calibrated at the manfacturer‘s site DocuMeterpH and PY-P…doc Automatic electrode recognition incl. type, order no. and serial number as well as the device used for the initial calibration Measuring results are based on data transferred from the Clip Disconnecting the DocuClip causes the meter to calculate the pH based on theoretical Nernst factor (59,16 mV/DpH at 25°C)

10. DocuMeter & DocuClipDocuClip using any elctrode DocuMeterpH and blank DocuClip Recognition of the DocuClip and its status Automatically starting the initializing routine Storing identification data and initial calibration data as „Initial Calibration“ for the whole life cycle of the electrode Storage of four additional calibration data sets in the DocuClip Any further calibration overwrites the oldest data set

11. Initial Calibration Electrode No. O 1 3 5 7 9 1 For cross-reference necessary: Cancel < > Entry in a lab journal … results in gap-less tracebility! DocuMeter & DocuClipDocuClip using any elctrode 6 digits can be stored in a blank DocuClip DocuClip electrode no. 135791 is pH electrode … (original serial no.) / … (manufacturer) / … (model or order no.)