The pharmaceutical industry is looking towards continuous
processing to improve their production quality in the most efficient way to the
level requested by the authorities today.
Consigma™ continuous high shear granulation and drying system
It allows for building quality into the process, to measure in-line and to
adjust parameters to drive the critical quality attributes to the requested
target levels.
This is clearly also the opinion of the authorities. In
order to give guidance to improve the overall production quality in the
pharmaceutical industry the FDA issued the PAT document in 2004. The document
states that the desired goal of the PAT framework is to design and develop
processes that can consistently ensure a predefined quality at the end of the
manufacturing process. One of the stated goals is to facilitate continuous
processing to improve efficiency and manage variability.
With this target in mind Consigma™ was developed.
Consigma™ - a new continuous high shear granulation and drying system
The Collette™ Consigma™ continuous high shear granulation and drying system
is designed for so-called plug flow, first-in first-out, avoiding back mixing
providing a consistent quality and allowing for control of critical quality
attributes in-line.
The Consigma™ consists of 3 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 a very accurate way to the continuous high shear granulator. The
granulation liquid is also dosed accurately and intensely mixed with the dry
components. Result is a continuous flow of wet granules with a constant quality
and constant density that is transferred to the dryer. There are no over-sized
agglomerates so there is no wet mill.
In an ingenious way, the dryer
module, based on the classic fluid bed drying principle, splits the continuous
flow of granules into segments of the dryer. The segments are emptied and
transferred to the evaluation module The drying curve of each package is
monitored.
In the evaluation module dried granules are received for dry
milling. Here we can measure critical quality attributes such as particle size
distribution, humidity and content uniformity in-line.
All data
captured can be analysed by the control system and parameters can be adjusted
to keep the process in a narrow band of the desired quality specification.
The Consigma™ can handle capacities from 500g up to tons. Time is the
factor that matters. Being able to handle all these capacities, there is no
scale-up anymore.
With its light weight, ultra small size and modular
construction Consigma™ fits in perfectly in every R&D department or an
existing tablet production room. No need to change the building, just wheel it
in, connect the power an air supply and off you go. Installation time and cost
are reduced to a fraction of the current benchmark.
It can
perfectly operate in mixed environment, with the possibility to do a parametric
release to the next step, a tableting process for instance.
Consigma™ — a success story from the start
Since the official launch at Interpack 2008 - Düsseldorf, Germany, 5
units have been sold : One multi-national company in the US and one
multi-national in Europe bought the machine for their R&D department
because of the proven improved quality of the end product after thorough
investigation. Another important aspect in their decision process was avoiding
scale-up and fast deployment.
The 3 other machines were sold to generic
suppliers in Europe and Mexico. Their decision was mainly based on 2 main
factors:
- The quality of the end product was so good and constant in comparison what
they currently produced on classic integrated line (HSM-FBD) Several products
were tested in our laboratory in Belgium and to the surprise of the customers
in all cases the tablet press was running at maximum speed with all tablet
characteristics perfectly within specification.
- The space requirement was the second reason. One company had to extend the
building if they wanted to install a classic batch granulation line. The
implementation of a Consigma™ in an existing tableting room will cost them a
fraction compared to the planned classic line.
Consigma™ — only the start of a full continuous production line
GEA Pharma Systems, in line with the Consigma™, have developed a continuous
blender which can be used for premixing or mixing the external phase in to the
granules in a continuous way. GEA Courtoy developed advanced in-line PAT on
their tablet presses which allows us now to provide a full continuous
production line of solid dosage forms. Such a line can be
demonstrated in our laboratory in Belgium.
Business Contact:
Wim Van der Goten
Sales
Director
GEA Pharma Systems nv - Collette™
BE-2160, Wommelgem,
Belgium
Office: +32 (0) 3 350 12 39 / Fax: +32 (0) 3 353 20 55,
Email:
wim.vandergoten@geagroup.com
Press Contact:
Kris De Baere
Marketing Manager
GEA
Pharma Systems
Office: +32 (0) 3 350 12 41, Mobile: + 32 (0) 473 73 19
45
Email: kris.debaere@geagroup.com