In order to be able to adhere to QbD specifications of IPM to obtain a mixed end product where an
«API» homogeneously (concentration deviation <2%) needs to be mixed in a high viscosty silicon oil
(viscosity over 2 million cps) a RAMAN spectroscopic device was used to optimize the mixing tools.

Figure 1: Percentage of label claim API in LSR/API mix at known areas of poor mixing before ajustments using a Krieger mixer.

 

The power of real time analysis was demonstrated during mixing trial work. During the mixing trials samples were taken from known areas of less efficient mixing: these are challenge samples. Figure 1 shows the 5 Raman results taken for each of 5 challenge samples. The RSD was 27% demonstrating poor mixing.
Figure 2 shows the same 5 challenge regions taken after modifications and an additional period
of mixing: the RSD for the same challenge positions was reduced to 2.5%.

Figure 2: Percentage of label claim API in LSR/API mix at known areas of poor mixing and during discharge after ajustments and two periods of mixing using a krieger mixer.

 

 

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