GEA Pharma Systems will be exhibiting its revolutionary Consigma™ continuous
high-shear granulation and drying system at ACHEMA 2009. The system satisfies
the pharmaceutical industry’s demand for continuous production to provide
improved quality, flexibility and consistency for pharmaceutical processes.
One Consigma™ can run 500g in R&D, but can also run clinical
trial, launch size, and any production size batches. There is no process
scale-up as time is the only relevant factor in a continuous process. This
allows manufacturers to reduce development time dramatically to reduce costs
and bring products to market much faster.
Compact, modular construction with very short installation time
The system is light weight, ultra small (1/4 of a classic
granulation line) and has a modular construction making it fit perfectly in any
R&D department or an existing tablet production room. There’s no need to
change the building, just wheel it in, connect the power and air supply, and
after a simple start-up period it’s ready to go. Installation time and cost are
reduced to a fraction of the current benchmark. It’s also possible to avoid
high peak energy periods and run at a continuous low energy consumption helping
companies meet their environmental obligations.
Consistent granule quality with improved compressibility
characteristics
Consigma™ is capable of doing particle design and
mimicking any traditional batch granulation process - with a much higher and
consistent quality resulting from its continuous production set up and ‘risk
based approach’ to GMP. The granules have generally a better intra-granular
porosity with better compressibility characteristics that help tablet presses
run more efficiently, at maximum speed with hardly any weight adjustments
required.
Consigma™ has three modules: a wet high-shear granulation module, a
segmented dryer module, and an evaluation module.
In the granulation module, dry ingredients are dosed,
individually or premixed, in the continuous high-shear granulator. After a
dry-mixing section, the granulation liquid is added, so each particle receives
the same amount of liquid.
The dryer module, based on fluid-bed drying principles,
splits the continuous flow of granules in packages of 1.5 kg, drying them each
in a separate segment of the dryer. When each segment is dry, it is emptied and
transferred to the evaluation module and refilled with a new package of wet
granules. The drying curve of each package is monitored, as a fingerprint of
the process, and controlled to maintain a constant end humidity over the whole
batch.
In the evaluation module the dried granules can be measured
for critical quality attributes such as particle-size distribution, humidity,
and content uniformity, using specially designed PAT tools.
To complete the continuous process line, GEA Pharma Systems
will also exhibit the GEA Courtoy MODUL™ P rotary tablet press based on the
innovative Exchangeable Compression Module (ECM) concept. The ECM is completely
isolated from the remainder of the machine, contains all product contact parts
and can easlily be removed from the press in a contained way. This means that
the press itself remains powder-free and requires no cleaning. With advanced
in-line PAT on their tablet presses – GEA Pharma Systems can now
provide a FULL continuous production line.
Visit
the GEA Pharma Systems stand at ACHEMA, Hall 4, D13 – G22 and see Consigma™ for
yourself. Book a demonstration of Consigma™
“You can count on us!”