The precise temperature control of Mya 4 is helping study key process parameters for API manufacturing
Contacts: Dr Timothy Davies
Organisation: Johnson Matthey
Country: UK (Scotland)
Product: Mya 4 Reaction Station
Case Study No: CS1904
The chemists in the Development department at Johnson Matthey Edinburgh are undertaking numerous projects to study key processing parameters during manufacture of active pharmaceutical ingredients. Experimental studies of one process in particular required highly accurate temperature control.
The Development department chemists were using a parallel reactor vessel with a fluid-filled heat / cool package for experimental studies. The parallel reactor vessel consisted of six reactor vessels housed in an aluminium jacket. It transpired that the temperature profile was not uniform in each of the reaction vessels. The lack of uniformity in temperature profiles between equivalent experiments was causing subtle, but statistically meaningful differences in impurity profiles during the analysis of experiments.
Because temperature was the most prominent variable affecting the impurity profile during the experimental studies, it proved difficult to quantify the effect of other variables (such as stirrer speed and reagent stoichiometry) on the impurity profile.
Using a temperature controlled parallel reactor vessel was essential for carrying out multiple experiments simultaneously. However, since the temperature profile of the parallel reactor vessel was linked to a single fluid-filled heat / cool package, multiple experiments had to be carried out using the same temperature profile.
It was hoped that new experimental apparatus could be sourced which could be used to accurately control the heating and cooling profile of an individual experiment, but the apparatus should still have the functionality of a parallel reactor vessel.
The Mya 4 was recommended by the Radleys team as a product which could act as a parallel reactor vessel and afford the level of temperature control required for thermally sensitive experimental studies. Mya 4 installation and training was provided to the chemists by the Radleys team. The analytical results obtained from experiments carried out using the Mya 4 showed much greater consistency compared to when using a parallel reactor vessel with a fluid-filled heat / cool package.
Reproducible analytical and experimental results were achieved because of the precision of temperature control that the Mya 4 provided. It was ultimately possible to accurately study key processing parameters, other than reaction temperature, which had more subtle effects on the impurity profile of the experiments. The level of temperature control that the Mya 4 has afforded will allow the Development chemists to carry out DoE (design of experiment) exercises on a scale which has not been previously achievable.
The precision of temperature control provided by the Mya 4 has been essential to understanding key processing parameters of temperature sensitive experiments.Dr Timothy Davies, Johnson Matthey