Salutas Pharma in Barleben, Germany has chosen a Mettler Toledo Sevenmulti pH meter to perform product quality-control tests.
Salutas makes pharmaceuticals in all solid dosage forms, including tablets, film-coated tablets and hard-gelatin capsules.
Salutas maintains modern facilities for production, analytics, quality control and microbiology.
One important task of the quality-control department is the preparation of HPLC media with a precisely defined pH value for subsequent HPLC determinations.
Sevenmulti's automatic data-acquisition feature saves valuable laboratory time by automatically determining pH value while another solution is being prepared.
If during the analysis another task arises that requires attention, the endpoint data acquisition is simply switched to 'manual' and the lab assistant retains full control over the entire determination.
To calibrate the sensors that determine pH value, the Salutas quality-control department uses three Sevenmulti instruments together with multiple Inlab413 / Expert Pro Sensors.
In the highly regulated pharmaceutical environment, sensor calibrations must cover the entire pH measurement range for HPLC solutions from pH 1.0 to pH 9.0.
With the Sevenmulti, up to five calibration points are possible and user-definable buffers, including temperature dependence, can be stored in the instrument.
With one user-defined buffer group utilising the buffers pH 1.0, pH 5.0 and pH 9.0, the Sevenmulti covers the entire pH measurement range with a three-point calibration.
At Salutas, sensor calibration is performed every morning before the first determination of the day so the highest degree of precision and reliability for the approximately 20 daily determinations can be guaranteed.
Salutas also checks the quality of the Inlab413 and Inlab Expert Pro Sensors on a daily basis.
After the calibration, the buffer solution with pH 7.0 is measured and the offset of the sensor is documented in the laboratory journal together with the corresponding sensor ID.
The results of the different determinations are printed out with all sample data on Mettler Toledo's compact RS-P42 printer.
This printout is also included in the laboratory journal for documentation.
As an additional service for Salutas, a Mettler Toledo service technician performed the initial quality certification of the instruments and the necessary equipment.
