GEA Pharma Systems integrate process engineering and PAT to provide Process
Intelligence
The FDA’s PAT (process analytical technologies) initiative has enabled GPS
Pharma Systems to combine its equipment design skills and process engineering
know–how in order to integrate online (PAT) analysers into its process systems
in a way which can provide real insight into the operation of the process and
help customers achieve key product quality target.
The goal of the PAT initiative is to ensure that pharmaceutical products are
manufactured using processes which are understood and monitored so that the key
quality characteristics of the products can be actively controlled.
Combining process monitoring using online analysers, together with solid
process engineering principles and advanced process modelling techniques will
enable processes to be actively controlled in order to compensate for minor
input variations (eg. raw materials) so that the specifications for the final
product will be closer to the ideal target.
Lighthouse Probe™ technology
GEA Pharma Systems has joined forces with J&M Analytik AG to
create a compact and cleanable in-process optical probe for use in powder
processing equipment. The probe overcomes the traditional problem of
observation windows fouling during processing.
The result is the novel Lighthouse Probe™, which can be used with a range of
spectroscopic
techniques, including NIR and UV/vis, to overcome the
traditional problem of product sticking to observation windows.
Parameters:
- drying end point
- granulation end point
- granulation homogeneity
- blending end point
- blending homogeneity
- coat thickness
- active content, ex. water, API, excipients
Features:
- full CIP possible
- in-line window wash
- in-line calibration
- no window fouling
- in-product measurement with 360 degrees
- various optical methods available (DA-NIR, FT-NIR, Raman, UV,
VIS)