The pharmaceutical industry, driven by the FDA initiatives, are putting ever
more emphasis on PAT and online monitoring. At GEA Pharma Systems we believe
that PAT goes beyond just integrating analytical tools, and should focus on
process understanding.
An important parameter to measure and understand
in a wet granulation and drying process, as executed on the equipment ranges by
GPS, is the homogeneity of the product after dry mixing. An inhomogeneous dry
mix will lead to inhomogeneous granules and thus problems with content
uniformity in the final product.
Near Infra red has been proven to be an
excellent technique to monitor blend homogeneity. GPS has built up experience
with on-line measurement of blend homogeneity in its Ultima high Shear
granulator/one-pot processor equipment range. Both qualitative (by using the
conformity index) and quantitative analysis (down to a level of 1% active
ingredient) has been proven useful to monitor and understand the dry mixing
process in a high shear granulator. Position of the NIR probe was shown to be
critical to achieve good measurements. Apart from experience with dry mixing,
GPS is also using NIR to monitor the drying process and other on-line
measurement techniques to monitor the granulation process.
With the
experience gained, GEA Pharma Systems is your partner of choice to implement
PAT tools for high shear granulation and single pot drying processes.