Special Pharmaceutical Plants
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.
Selected references
Example 1
Production facility for influenza vaccine
Client:
Sächsisches Serumwerk GmbH Dresden, a subsidiary of the GlaxoSmithKline-Group
Location:
Dresden / Germany
Type of order:
General planner for planning and implementation of the isolatorline ISO 2 + formulation suite (B)
Type of plant:
Sterile formulation of vaccines, fill & finish
Scope of work:
EPCMV (basic & detail engineering, procurement, construction management, validation)
Planning period:
2005 -2007
Example 2
Peptide synthesis pilot plant
Client:
Novo Nordisk A/S
Location:
Bagsværd / Denmark
Type of plant:
Pilot plant for the synthesis of different peptides
Scope of work: Conceptual design engineering procurement construction management (EPCM) commissioning qualification |
Planning period:
2006 - 2007
Example 3
Plant for filling of large volume parenterals
Client:
Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.
Location:
Vienna /Austria
Type of plant:
New plant for filling of blood plasma fractionation products (isolation technology)
Scope of work: conceptual engineering basic engineering detail engineering qualification utility piping |
Planning period:
2002 - 2004
Example 4
Fine chemicals
Client:
DEGUSSA AG
Location:
Trostberg / Germany
Type of plant:
GMP-multi purpose pilot plant for the production of active ingredients
Scope of work: extended basic detail design procurement construction qualification start-up |
Completion:
2002
Example 5
Plants for the production of finished dosage forms
Client:
Gedeon Richter AG
Location:
Budapest / Hungary
Type of order:
Complete reconstruction, construction of a new research building, construction of a new logistics complex, validation of the production plants and FDA approval
Products:
Solid and semi-solid dosage forms
Scope of work: turnkey plants for production in compliance with FDA general contractor authority engineering, basic engineering, detail engineering supply of equipment, installation qualification, commissioning, validation |
Commissioning:
2000
Example 6
Production of active pharmaceutical ingredients
Client:
FDS Pharma ASS. London
Location:
St. Petersburg / Russia
Type of order:
Turnkey multipurpose plant for the production of active pharmaceutical ingredients
Scope of work: General contractor basic engineering detail engineering procurement, construction supervision of start-up qualification (DQ, IQ) |
Completion:
2001
Example 7
Multi purpose plant - Kilo-Laboratory
Client:
F. Hoffmann-La Roche AG
Location:
Basle / Switzerland
Project:
Kilo-Laboratory
Type of plant:
Multipurpose pilot plant for new active pharmaceutical ingredients
Scope of work: basic engineering detail engineering sub contractor management |
Completion:
2001
Example 8
Pilot plant ‚VE Chemie‘
Client:
Bayer AG
Location:
Wuppertal-Elberfeld / Germany
Type of plant:
Multi-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
Products:
APIs for pre-clinical and clinical trials as well as intermediate products
Scope of work: design verifikation basic engineering detail engineering procurement qualification ‚as built‘ documentation |
Start-up:
2000
Example 9
Plant for the production and packaging of insulin
Client:
Biomed, Kiev
Location:
Kiev / 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
high resolution purification manufacture of solution filling and packaging of ultra-pure insulin as well as auxiliary and subsidary facilitie |
Licenser:
Hoechst AG, Frankfurt-Höchst
Product:
Insulin of highest purity
Scope of work:
Turnkey plant in compliance with GMP
Completion:
1997
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Further references
Highly active substances
Construction of Plants for the production of sterile liquids and semi-solid dosage forms with highly active ingredients using isolator technology for the
F. Hoffmann-La Roche AG in Basel in Basle (Switzerland),
project coordination, the process of detail engineering, support in procurement, erection supervision and qualification in the period 2006/2007
