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Linxis Group

The DIOSNA glossary


Technological terms in an overview

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Coater


Equipment for coating powders, granules, pellets or tablets. Fine-grained product is usually coated in fluid bed units. Tablets are preferably coated in specially designed vertical or horizontal coaters (tablet coaters).

Coating


Process to coat powers, granules, pellets or tablets. For coating it is necessary that the products pass the spraying device in a defined and reproducible way to achieve homogeneous layer forming.

Cartridge filter


Cylindrical or conical cartridges made of various materials used for instance in fluid bed plants to clean the process air from fine dust. In most cases cleaning is effected by a pressure pulse which removes the filter cake from the cartridge. The used filter materials are e.g. cloth of polyamide or stainless steel.

CCS (Closed Combined System)


Combined system made of individual plants P-mixer-granulator and CAP-fluid bed batch processor for wet granulation and immediately following drying of pharmaceutical powder mixtures. Mixer and dryer are combined by a pipe connection. The transfer of the final wet granule and the drying with subsequent discharge are effected completely automatically. Thus only minimum manual product handling is necessary.

CE Label


The CE-label indicates that a machine is designed according to the relevant CE-guidelines and that it may be marketed.

cGMP (Current Good Manufacturing Practise)


(Current Good Manufacturing Practise) are the rules of Good Manufacturing in the United States which are currently – yearly – checked and revised, if necessary.

CGS (Compact Granulation System)


Compact granulation unit of P-mixer-granulator and CAP-fluid bed processor for wet granulation and immediately following drying of pharmaceutical powder mixtures. The CGS offers a compact installation as well as a short product transfer, and thus it improves the entire cost situation as well as the process safety of the plant.

Changeable Bowl


Especially the DIOSNA mixer-granulators and fluid bed units which are designed as laboratory machines can be equipped with changeable bowls to produce batches of different size. This is advantageous for product development, as the bowl sizes can be adjusted to the available raw material and to achieve data for scale-up.

CIP (Cleaning-In-Place)


Automatic and reproducible cleaning of plants with a defined cleaning result and without the need to disassemble parts or to modify them essentially.

Containment


Process of encasing a biological agent or another material in a defined space. Primary containment: a containment system which prevents a biological agent from escaping to the proximate working surroundings. For this purposes closed containers or biologically safe working places are necessary, together with safe working procedures. Secondary containment: a containment system which prevents a biological agent to the outside or in other working surroundings. For this purpose rooms with special aeration are necessary as well as transfer ports and/or sterilizers to take out materials in safe working procedures. In many cases the effectivity of the primary containment can be increased. For the production of pharmaceutical solid dosage forms, high-potent substances are increasingly used which must be processed under containment conditions. Therefore mixer-granulators or fluid bed processors can be equipped with special containment interfaces to realise a completely closed handling of the product from feeding to discharging the units.

Cloth filter


Cartridge filters which consist of a stainless steel cage covered by the filter cloth of polyamide. If the filter is dedusted by back blowing, the filter cloth is inflated and shakes the deposited filter cake off the surface. In case of solid filters, e.g. stainless steel cartridges, the flexibility of the filter material is considerably restricted which may result in a steady formation of filter cakes, if sticky materials are processed.

Clean gas side


Air guiding area beyond the filter steps. With fluid bed units usually the area behind the product filters.

Chopper


Tool in the mixer-granulator to split lumps, for optimal distribution of granulation liquid and compaction of the granules. Depending on the application the chopper tool is available in various geometries.

Calibration


Comparison of set and actual values between a measuring device installed in the plant and a comparison standard.

Control System


The control system controls the functions of the plant. In most cases it is based on a programmable logic computer (PLC) and a user interface. For most of the DIOSNA plants the PLC is based on the Siemens S7 or alternatively on Allen-Bradley.

Coating uniformity


Uniformity of the coating on one resp. between numerous tablets. Quality indicator for the coating process.

CIP skid


Station with all components which are necessary for the preparation of the cleaning medium for WIP or CIP cleaning of the particular equipment. The station consists at least of the valves for the cleaning media such as cold water, hot water, DI-water, compressed air as well as the valves to distribute them to the consumers. In addition the station can include heater, cleaning media dosing, pressure increasing pump, tanks and others.

Continuous processes


In continuous processes the product is produced in continuously running process steps. The continuous procedure causes an uncertainty regarding the traceability of the condition of one specific product sample out of the complete lot as parameters, point in time and localization cannot be determined. The total quantity is defined by the duration of the continuous process. The size of the plant defines the hourly output. On the contrary batch operation means the production of an exactly defined product quantity in one single product batch. During the batch operation the condition of the whole product batch is evident at every moment of the process. The product quantity is defined via the size of the production machine.

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