Current Good Manufacturing Practices increasingly require that
product is fully contained during processing to protect operators and
environment. Integrated process systems not only offer containment but improved
productivity through automation, increased yield and efficient cleaning
procedures.
GEA Pharma Systems is uniquely qualified to provide integrated
High Shear Mixer Granulator and Fluid Bed technology. Drawing
on the world class expertise of GEA Pharma Systems technologies, we offer fully
integrated turnkey installations including fluid bed process equipment combined
with Top- and Bottom-drive High Shear Mixer-Granulators from
Aeromatic-Fielder™ and
Collette™. Our service
includes design, installation assistance, commissioning, process validation, as
well as training, and technical support. Installation, operation qualification
and documentation are carried out according to FDA/GAMP guidelines.
Using proven standard components, GPS can supply both simplicity and
flexibility in plant design. User-selected process options, cleaning equipment,
control systems and PAT technologies combine in a system to meet process
requirements exactly. This approach ensures that qualification and validation
procedures are kept to a minimum.
Through-the-wall configuration
Through-the-wall offers
the best option in terms of cleanliness, maintenance and ATEX. By keeping the
motors out of the process room, you are preventing risk of contamination coming
from these difficult to clean items. Maintenance is carried out from the
technical area, minimising the need for the maintenance engineer to work in a
GMP area. This makes the job easier and
again reduces the risk of
contamination. For ATEX, the design allows us to classify the technical area as
safe. This avoids the need for costly flameproof motors, making the upgrade for
working with solvents much easier.