Using standard components, Collette™ - GEA Pharma Systems Systems can
supply both simplicity and flexibility in high shear granulator plant design
for the pharmaceutical industry. User selected process options, control systems
and liquid preparation units combine to exactly meet process requirements. This
approach ensures that qualification and validation efforts are kept to a
minimum.
UltimaGral™ High Shear Granulator
Through-the-wall
offers the best option in terms of cleanliness, maintenance and explosion
protection. The Through-the-wall configuration provides a sealed separation
between technical and GMP space by the machine itself. This offers a clear
containment concept including
explosion area separation that fulfills the
latest requirements like ATEX.
By keeping technical components out of the
process room, the equipment is much easier to clean. Maintenance is carried out
from the technical area, reducing the need for the
maintenance engineer to
work in a GMP area. This reduces downtime and the risk of contamination. For
ATEX, the design allows the technical area to be classified as safe.
Loading
Depending on the layout of the production area,
several options for loading the powders are available. When the processing room
is sufficiently high, gravity loading is applicable, using post hoists to lift
the IBC on top of the UltimaGral™ (or Gral™). Alternatively gravity loading
with the IBC located on a docking station on the floor above the machine is
possible if a multiple floor installation is preferred. In height-restricted
areas however, vacuum loading can be used. In this case the product is sucked
into the processing vessel from an IBC located close to the machine on the
floor.
Moveable Head
The UltimaGral™ can be equipped with a
‘Movable Head’ to enhance flexibility. This feature allows operators to lower
the closed bowl to enable better accessibility and easy loading. The closed
bowl can also be raised for dust free discharging. This option is extremely
useful in height-constrained processing areas
Binder solution addition
In a wet granulation process,
binder addition is one of the critical phases determining product quality. A
range of binder addition systems is available to give the optimum binder liquid
droplet size. This ensures an even distribution throughout the powder mass, for
different viscosities. The liquid is transferred to the mixing bowl using a
peristaltic pump or pressure vessel, while the rate and amount is controlled by
a loss in weight system, or a mass flow meter.