Collette (part of GEA Pharma Systems group) has integrated its
knowledge and experience in pharmaceutical granulation and drying
processes to help operators monitor and control the process in an easy
and self explanatory way. Depending on the automation and reporting
requirements, Collette can offer two different control systems both of which
provide the
operator with all necessary process information in a clear and
easy to understand way.
Process Control
- OP/ PLC control system
This control system provides
basic functionality and process visualisation with data recording via a
separate paperless recorder. It is designed to be FDA 21 CFR Part 11 compliant
and provides a basic level of process automation with recipe control.
- Procoll Pro control system
This SCADA based control system
provides a maximum level of flexibility and functionality in terms of process
visualisation, automation and data recording. It is designed for integration
with customer MES systems for receiving and reporting GMP relevant data. The
system is very much process orientated and guides using in-built
intelligence the
creation of recipes and automatic processing. All process
data is stored in a
relational database. The system is fully FDA 21 CFR
Part 11 compliant and
provides features like audit trail including
reporting and configurable
graphs for process values. This batch control
system is designed according to
the S88.01 batch control standards.
A video camera installed in
the head of the machine provides a complete view into the process vessel. This
is the ideal tool for state of the art processing and gives the operator a
clear indication of the product behaviour and flow during granulation while the
vessel is closed. Not only for product development but also for production this
feature provides a huge advantage for modern integrated and contained
processing.
PAT integration As well as the
classical tools for monitoring and controlling process like torque measurement
or temperature for granulation and drying control, Collette has
developed innovative solutions for the integration of NIR (near infrared) and
FBRM (focused beam reflectance measurement) sensors into its processes and the
controls.
These advanced measurement tools are used for the direct
measurement of product quality parameters such as moisture content, homogeneity
of the mix, and particle size distribution,
providing control parameters
for direct release of the product.
GEA Pharma Systems (GPS) has joined forces with J&M GmbH to create a
compact and cleanable in-process optical probe for use in powder processing
equipment.
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.