| In this business segment, plants for chemical synthesis of pharmaceutical substances and plants for formulation of pharmaceuticals for human application are planned and constructed active substances in dosage forms suitable are planned and constructed.
In the field of chemical synthesis of active substances Linde-KCA-Dresden has gained profound and comprehensive special knowledge about chemical processes and process engineering and their application to equipment design in state-of-the-art plants. A specialized team is available for planning the required clean rooms, ventilation systems and clean media supply. Due to the interdisciplinary cooperation with internal experts for process engineering, layout panning, handling and logistics as well as for instrumentation and automation modern and highly automated plants for synthesis of active substances and for the production of finished dosage forms can be designed and erected.
Linde-KCA-Dresden has gained comprehensive special knowledge in the field of solid (tablets, capsules, powders, granules), semi-solid (ointments, geles, pastes) and liquid dosage forms (filling in ampoules, vials, syringes and carpules).
Since the international regulations of Good Manufacturing Practise (GMP) are of particular importance for success of this planning segment, in order to ensure compliance with GMP, Linde-KCA-Dresden has developed a special GMP-/ qualification manual and planning algorithm meeting the requirements of this complex planning task.
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Example 1
Fill & finish facility for influenza vaccine |
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Client |
| GlaxoSmithKline Biologicals, Dresden |
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Location |
| Dresden / Germany |
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Type of order |
| General planner for planning and implementation of the isolatorline ISO 2 + formulation suite (B) |
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Type of plant |
| Sterile fill & finish of vaccines, formulation |
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Scope of work |
| EPCMV (basic & detail engineering, procurement, construction management, validation) |
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Planning period |
| 2005 -2007 |
Example 2
Peptide synthesis pilot plant
ClientNovo Nordisk A/S
LocationBagsværd / Denmark
Type of plantPilot plant for the synthesis of different peptides
Scope of work||
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Conceptual design |
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engineering
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procurement
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construction management (EPCM)
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commissioning
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qualification |
Planning period2006 - 2007
Example 3
Reconstruction of process plants for pharmaceutical research
ClientF. Hoffmann-La Roche AG
LocationBasel/Switzerland
Type of plantPlants for the production of sterile liquids and semi-solid dosage forms with highly active ingredients using isolator technology
Scope of work||
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project coordination |
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detail engineering for process technology
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procurement support
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supervision of installation
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qualification support
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Planning period2006/2007
Example 4
Plant for filling of large volume parenterals
ClientOctapharma Pharmazeutika Produktionsgesellschaft m.b.H.
LocationVienna /Austria
Type of plantNew plant for filling of blood plasma fractionation products (isolation technology)
Scope of work||
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conceptual engineering |
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basic engineering |
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detail engineering |
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qualification utility piping |
Planning period2002 - 2004
Example 5
Fine chemicals
ClientDEGUSSA AG
LocationTrostberg / Germany
Type of plantGMP-multi purpose pilot plant for the production of active ingredients
Scope of work
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extended basic |
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detail design |
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procurement |
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construction |
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qualification |
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start-up |
Completion2002
Example 6
Plants for the production of finished dosage forms
ClientGedeon Richter AG
LocationBudapest / Hungary
Type of orderComplete reconstruction, construction of a new research building, construction of a new logistics complex, validation of the production plants and FDA approval
ProductsSolid and semi-solid dosage forms
Scope of work
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turnkey plants for production in compliance with FDA |
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general contractor
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authority engineering, basic engineering, detail engineering
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supply of equipment, installation
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qualification, commissioning, validation |
Commissioning2000
Example 7
Production of active pharmaceutical ingredients
ClientFDS Pharma ASS. London
LocationSt. Petersburg / Russia
Type of orderTurnkey multipurpose plant for the production of active pharmaceutical ingredients
Scope of work
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General contractor |
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basic engineering |
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detail engineering |
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procurement, construction |
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supervision of start-up |
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qualification (DQ, IQ) |
Completion2001
Example 8
Multi purpose plant - Kilo-Laboratory
ClientF. Hoffmann-La Roche AG
LocationBasle / Switzerland
ProjectKilo-Laboratory
Type of plantMultipurpose pilot plant for new active pharmaceutical ingredients
Scope of work
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basic engineering |
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detail engineering |
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sub contractor management |
Completion2001
Example 9
Pilot plant ‚VE Chemie‘
ClientBayer AG
LocationWuppertal-Elberfeld / Germany
Type of plantMulti-purpose plant for the scale-up of processes and production of new active pharmaceutical ingredients (API) in compliance with GMP guidelines based on process know-how of Bayer
ProductsAPIs for pre-clinical and clinical trials as well as intermediate products
Scope of work
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design verifikation |
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basic engineering
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detail engineering
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procurement
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qualification
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‚as built‘ documentation
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Start-up2000
Example 10
Plant for the production and packaging of insulin
ClientBiomed, Kiev
LocationKiev / Ukraine
Type of order
Construction of a complete plant as joint project of Linde-KCA-Dresden GmbH and Glatt GmbH Weimar, consisting of plants for
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high resolution purification
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manufacture of solution
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filling and packaging of ultra-pure insulin
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as well as auxiliary and subsidary facilities
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LicenserHoechst AG, Frankfurt-Höchst
ProductInsulin of highest purity
Scope of workTurnkey plant in compliance with GMP
Completion1997
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