Having identified a difficulty in maintaining GLP or ISO-compliant documentation of pH meters, this neat solution enables the individual components to maintain traceable calibration
Sartorius has introduced two new products, the DocuMeter and DocuClip, that it says offer unique features for the documentation of data from pH testing.
GLP or ISO-compliant documentation of results is the current standard in the majority of laboratories and is automatically supported by many laboratory measuring instruments.
However, with a closer look, it becomes obvious that the documentation and traceability of the measured data is not quite as seamless as necessary for a group of commonly used measuring instruments: pH meters.
The problem lies in the fact that the meter and sensor are two components of one system which are not capable of producing the desired pH reading of a measurement until they are combined.
Strictly speaking, all requirements for the GLP or ISO-compliant documentation of procedures and results must be applied to each component of the entire system.
Thus, for pH measurements, the identification and allocation of the calibration data and measured results logged by the device must be clearly traceable for both pH combination electrode and meter.
The new Sartorius DocuMeter and DocuClip product series has solved this problem in a surprisingly simple way.
Inseparably attached to the pH electrode, the DocuClip knows the type designation and serial number of its own electrode.
Moreover, DocuClip securely stores the data from up to four complete calibration datasets in its rolling memory, which means it deletes older data to make room for the latest calibration report.
As soon as DocuClip is connected to the DocuMeterpH, the electrode data available in the DocuClip is transmitted to the DocuMeterpH, which uses this data for measurement evaluation and meticulous data recording.
Updated calibration data is written to DocuClip's memory where it is irreversibly linked to the matching electrode.
This pragmatic solution to the problem automatically allows seamless traceability of pH measurements to the meters and sensors used.
Sartorius supplies the DocuClip permanently connected to a pH electrode - pre-initialised and factory calibrated.
However, the DocuClip can also be purchased unformatted, allowing the user to initialise and irreversibly attach it to almost any electrode.
Even without DocuClip, the new Sartorius pH meters offer everything that can be expected of lab pH meters offering cutting-edge technology.
As of June 2005, Sartorius will be offering two variants equipped with different features.
Together DocuClip and the new DocuMeterpH offer a unique solution to GLP and ISO compliance.