In the pharmaceutical industry, obtaining precise and reliable test results in a short period of time is undoubtedly important. For this reason, Salutas Pharma GmbH in Barleben, Germany, uses a METTLER TOLEDO SevenMulti pH Meter to perform product quality control tests.
Uncompromised quality
With approximately 1350 employees, Salutas is one of Europes most advanced and competitive pharmaceutical production sites. The companys product portfolio includes pharmaceuticals in all solid dosage forms including tablets, film-coated tablets and hard-gelatin capsules. In addition to state-of-the-art production facilities, Salutas also maintains highly modern facilities for 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. Since this is a routine task for the highly trained lab assistants, the SevenMultis automatic data acquisition feature is quite useful. It also saves valuable laboratory time by automatically determining pH value while another solution is simultaneously 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.
We often use the automatic data acquisition for our routine determinations that saves us a lot of time, said Katy Brom, a lab assistant at Salutas.
Covering the entire range
However, a highly precise determination of the pH value requires much more than a simple measurement alone. Quality starts with proper preparation, i.e. calibrating the sensors to be used. For this process, the Salutas quality control department uses three SevenMulti instruments together with multiple InLab413 / Expert Pro Sensors. In the highly regulated pharmaceutical environment, it is required that sensor calibrations cover the entire pH measurement range for HPLC-solutions from pH 1 to pH 9.
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 utilizing 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.
Quality documentation
The quality of the InLab413 and Inlab Expert Pro Sensors is also checked 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 the compact RS-P42 Printer from METTLER TOLEDO and 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. We are very pleased about the professional service and good cooperation we received, said Dr. Gerald Ohms, leader of the QC method transfer lab at Salutas.
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