08.2005 BK

Traceable pH measurements and GLP compliant documentation

Sartorius DocuClip & DocuMeterpH

The new standard for reliability in electrochemical analysis

08.2005 BK

Traceable pH measurements and GLP compliant documentation

pH measurement: Generating and documenting data

Evaluation of signals

pH electrodes 1, 2, 3, ...

Transmission of measuring signal

pH meter

Origin of measuring signal

Display of cal-culated pH value

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

08.2005 BK

Traceable pH measurements and GLP compliant documentation

pH measurement: gaps in documentationExamples of GLP-compliant documentation today

------------------------ SARTORIUSStd. data13-12-2004 13:48:31Model PP-25Serial No. 12143916------------------------Channel A: pH modeStd interval off 4.01 pH 13-12-2004 13:48:3198.79% (58.45 mV/pH) 7.00 pH 13-12-2004 13:47:09Standardization ok.Name:

Documentation of equipment : meter model: meter serial number,: meter software version: date / time of standardization and measurements

What about the electrode?

No documentation : of electrode serial number : that calibration base and measured value have been evaluated with the identical electrode

but

08.2005 BK

Traceable pH measurements and GLP compliant documentation

What is needed to complete the documentation of a pH system?

Evaluation of signals

Transmission of raw measuring signal

pH meter

Origin of measuring signal

Display of cal-culated pH value

Sending back the information how to evaluate the raw signal

Sending this information back to the meter …

along with ID information

Storing this specific infor-mation in the individual electrode and

08.2005 BK

Traceable pH measurements and GLP compliant documentation

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

08.2005 BK

Traceable pH measurements and GLP compliant documentation

The new Sartorius approachA memory attached to the electrode cable

— 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

DocuClip

08.2005 BK

Traceable pH measurements and GLP compliant documentation

Documeter and Docuclip: gaps in documentation closedGLP-compliant documentation

: 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

Documentation now includes

08.2005 BK

Traceable pH measurements and GLP compliant documentation

pH measurement: gaps in documentation closedExamples of GLP-compliant documentation today

Documentation of equipment and electrode

including: model ID and serial number: date and time of standardi- zation and measurement: measured value is related to the underlying standardization data

08.2005 BK

Traceable pH measurements and GLP compliant documentation

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/pH at 25°C)

Electrode type pH: PY-P12

Serial NumberA044805026

Model f. Cal.Cal.Ser:

device9876543210

OK

08.2005 BK

Traceable pH measurements and GLP compliant documentation

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

Initial Calibration

Input Serial No.

Cancel Start

Initial Calibration

Programming DocuClip

08.2005 BK

Traceable pH measurements and GLP compliant documentation

Initial Calibration

Electrode No.

O O O O O O 0

Cancel

<

>

6 digits can be stored in a blank DocuClip

DocuMeter & DocuClipDocuClip using any elctrode

>

<

Cancel

1 3 5 7 9 1O

Electrode No.

Initial Calibration

DocuClip electrode no. 135791

is pH electrode … (original serial no.) / … (manufacturer) / … (model or order no.)

Entry in a lab journal For cross-reference necessary:

… results in gap-less tracebility!