Facilities
The PDC is separated into 3 areas: 2
production units on the ground floor and 1 office area (with the offices for
the PDC personnel and 2 meeting rooms) on the first floor.
The 2
production units can be entered form the central hallway through a lock space.
In this lock space, all necessary clothing is present to change for entrance
into the production area.
In the first area, an UltimaPro™ 75 is
permanently installed for product trials. The other area has room for
an UltimaPro™ 10, if not rented out, and a tablet press and also harbors a
small analytical laboratory.
Equipment
ConsiGma™ 25
The new, revolutionary continuous
high shear granulation and drying system by GEA Pharma Systems is available for
testing in the PDC. The ConsiGma™ 25 can be tested using 1 or 2 powder feeders,
for using pre-blends or for testing the mixing capabilities of the system. It
is also equipped with online measurement tools, such as the LightHouseProbe™,
to evaluate continuously the critical quality attributes of your product.
The system can also be connected with the Modul P tablet press available in
the same productiion room to form a truly continuous tabletting line to which
powders are fed, and from which tablets exit.
UltimaPro™ 75
The UltimaPro™ 75
installed in the PDC is a full option machine. This means it has all drying
techniques included (vacuum drying, gas-assisted vacuum drying and microwave
drying). It is equipped with a swinging bowl, a fully operational CIP system
(with 5 cleaning media: cold and warm water, detergent, demineralized water and
purified air) and is controlled by the state-of-the-art PC-PLC batch control
system, PROCOLL PRO. This new software control system complies with the highest
validation standards and the S88.01 standard for batch control.
The
UltimaPro™ 75 is a through-the-wall installation, which means that it is
permanently installed in the PDC and thus always available for product trials.
UltimaPro™ 10
The UltimaPro™ 10 is also a
full option machine, offering all available drying techniques, the swinging
bowl and the easy-to-use operator panel control system.
The UltimaPro™
10 can be rented for an unlimited period of time for doing trials in your
own facility. For more information on the terms and conditions for renting the
UltimaPro™ 10, contact the Lab Manager.
MicroGral™
The PDC always has one or more
MicroGral™ available for small-scale granulation trials.
This equipment
can also be rented for an unlimited period of time for doing trials in your own
facility. For more information on the terms and conditions for renting the
MicroGral™, contact the Lab Manager.
Courtoy Modul P Tablet Press
For
evaluation of the quality of the produced granules, a Modul P tablet
press by Courtoy is permanently available in the PDC.
Analytical equipment
Equipment is on hand for
moisture determination (halogen, IR), sieve analysis, microscopic evaluation,
tablet analysis, flow ability measurement.