Bereidingsvoorschriften met vaste hoeveelheden zuur of loog: Zonder pH-meter toch de juiste pH

Still a considerable amount of products, including aseptic preparations, are being manufactured in Dutch hospital pharmacies. Some of these products need pH adjustment during preparation. This leads to some practical problems in the aseptic process. In the hospital pharmacy Midden-Brabant, we therefore conducted a process validation procedure for the adjustment of pH of aseptic preparations. Process validation is an important part of good manufacturing practice (GMP). The purpose is to define the necessary volume of acid or base to adjust the pH. After completion of the validation procedure, in-process measurement of the pH is not necessary anymore. It is sufficient to measure the pH of the final product. We successfully completed this procedure for some of our products. This is an easy method for the technicians to participate in process validation and to bring GMP to their attention.