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esponsibility have to be def<strong>in</strong>ed, quotations obta<strong>in</strong>ed and costs<br />
calculated <strong>in</strong> order to arrive at the solution that provides the best<br />
possible cost-to-performance ratio. All these factors - and many<br />
more - were borne <strong>in</strong> m<strong>in</strong>d and bit by bit pieced together for the<br />
new facility. After many effective meet<strong>in</strong>gs between <strong>Glatt</strong>, PM and<br />
Genzyme and hav<strong>in</strong>g been carefully coord<strong>in</strong>ated, <strong>Glatt</strong> is now<br />
supply<strong>in</strong>g pharmaceutical solids production equipment, and<br />
work<strong>in</strong>g <strong>in</strong> perfect harmony: A s<strong>in</strong>gle supplier source with a<br />
s<strong>in</strong>gle process guarantee.<br />
The equipment used to handle pharmaceutical solids is the allimportant<br />
logistic and process technology l<strong>in</strong>k connect<strong>in</strong>g <strong>in</strong>dividual<br />
process steps such as weigh<strong>in</strong>g, mix<strong>in</strong>g, blend<strong>in</strong>g and<br />
tablett<strong>in</strong>g on the one hand and auxiliary processes such as<br />
homogenisation and clean<strong>in</strong>g on the other.<br />
The type of product flow, the degree of automation and the conta<strong>in</strong>ment<br />
level are <strong>in</strong>strumental <strong>in</strong> determ<strong>in</strong><strong>in</strong>g how any complete<br />
plant or <strong>in</strong>stallation is planned. The provision of the patented<br />
<strong>Glatt</strong> SKS valve system ensures a total conta<strong>in</strong>ed <strong>in</strong>terface for the<br />
process units and dispens<strong>in</strong>g stations for the charg<strong>in</strong>g and<br />
discharg<strong>in</strong>g of highly potent powders, hence a solution for an<br />
application <strong>in</strong> OEB-4 areas is herewith provided.<br />
While the weigh<strong>in</strong>g-<strong>in</strong> of active substances is generally performed<br />
manually <strong>in</strong> a weigh<strong>in</strong>g cab<strong>in</strong>, the base carrier materials and<br />
additives are usually measured and added <strong>in</strong>to conta<strong>in</strong>ers on<br />
automatic weigh<strong>in</strong>g trucks.<br />
Siev<strong>in</strong>g and mill<strong>in</strong>g techniques are used to separate or reduce<br />
the size of agglomerates <strong>in</strong> order to obta<strong>in</strong> a homogeneous gra<strong>in</strong><br />
structure for the subsequent production process.<br />
Even distribution of the formulation components is ensured by<br />
dry blend<strong>in</strong>g us<strong>in</strong>g conta<strong>in</strong>er blenders. The equipment can be<br />
cleaned either manually or <strong>in</strong> fully automatic wash<strong>in</strong>g systems.<br />
In addition to the product flow itself, factors such as preparation,<br />
adm<strong>in</strong>istration and reliable data transport play an ever more<br />
important role <strong>in</strong> terms of reproduction accuracy and process<br />
safety. Integrated systems are <strong>in</strong> great demand – preferably from<br />
one s<strong>in</strong>gle source. The ma<strong>in</strong> criteria with product handl<strong>in</strong>g are<br />
primarily determ<strong>in</strong>ed by the type of product flow, the degree of<br />
automation and the level of conta<strong>in</strong>ment. Whether weigh<strong>in</strong>g,<br />
dos<strong>in</strong>g, blend<strong>in</strong>g, siev<strong>in</strong>g, stor<strong>in</strong>g, transport<strong>in</strong>g, dock<strong>in</strong>g or the<br />
necessary documentation, either manually or automatically controlled<br />
– <strong>Glatt</strong> is provid<strong>in</strong>g the latest and proven state of the<br />
art solution technology <strong>in</strong> close cooperation with the project<br />
partners for the new Genzyme plant.<br />
Schematic view of the product and data flow<br />
<strong>in</strong> a pharmaceutical operation<br />
Patented, contam<strong>in</strong>ation-free flap system<br />
(Conta<strong>in</strong>ment Flap)<br />
Contam<strong>in</strong>ation-free<br />
flap system: SKS<br />
Contam<strong>in</strong>ation-free flap system:<br />
Schematic diagram <strong>in</strong>cl. detail<br />
Ralf Kretzschmar is a graduated eng<strong>in</strong>eer <strong>in</strong> cybernetics<br />
from the University of Ilmenau, Germany.<br />
After ten years of sound experience <strong>in</strong> light eng<strong>in</strong>eer<strong>in</strong>g<br />
he jo<strong>in</strong>ed <strong>Glatt</strong> Systemtechnik Dresden as<br />
Vice President and Sales Director.<br />
Contact: Ralf.Kretzschmar@glatt.com<br />
International Times No. 27 · March 2009<br />
11