Minitueb GmbH, Landshut, Germany (2007 - 09)
Feasibility study, basic and detailed engineering and design for cleanrooms, logistics and process plant, process planning and cleanroom design,
construction management for construction of a new GMP compliant production line for veterinary products including building services, quality control and logistics, machine procurement, requirement specifications, risk analysis and setup of the company organisation required
Spetec GmbH, Erding, Germany (2007)
GMP review and GMP consultation for optimising the hygiene design of LF cabins and LF boxes
Projekt Eigenblutzytokine, Grünwald, Germany (2007 - 09)
Feasibility study for retrofitting old class B cleanrooms including GMP compliant building services and production facilities for cleanrooms with
state of the art GMP-conforming process plants
Astra Zeneca, Bangalore, India, (2006)
Review of the GMP layout for the new production facility for prostaglandin on behalf of LSMW Germany
Roche Diagnostics GMBH, Penzberg, Germany (2005 – 06)
Site management process for the bio-technology plant Biologics IV (Herceptin containing the active ingredient trastuzumab) as a partner of the Construction Manager Siemens SIBC (Project volume approximately € 290 million);
responsible for the assembly of whole pipework, process equipment and the setup of process planning / project management and construction management; fast track conditions
Roche Diagnostics GMBH, Penzberg, Germany (2002 - 05)
Site management process for the EPO 1k and EPO 5k bio-technology projects as a partner of the Construction Manager Bovis Landlease (Project volume approximately € 130 million); responsible for quality,scheduling, documentation and costs of the overall process installation of the new plant Biologics III, qualification preparation and installation support
Die Hirsch Apotheke, Öhringen, Germany (1998 – 2000, 2005 - 08)
General planning and construction management for the retrofitting of existing pharmacy rooms to class B cleanrooms for separate manufacture of sterile products and cytostatic drugs, including new ventilation and air conditioning technology and plant qualification
Naturapharm AG, Grünwald, Germany(2001)
Consultancy, conceptual design and cost estimate for a new pharmaceutical factory for the manufacture and packaging of semi-solids including storage areas, administrative and social areas for approximately 25 million packages annually
Pharmazell GMBH (previously known as Noveon), Raubling, Germany (1999)
GMP consultation and conceptual design for the execution of a new GMP compliant drying booth as the final stage of production of
active pharmaceutical ingredients (APIs)
German Arab Chamber of Industry and Commerce, Jordan and Syria (2002)
Series of lectures on “HACCP and hygiene in pharmaceutical and food industries” in Jordan and Syria on behalf of the German Arab Chamber of Industry and Commerce
Mundipharma GMBH, Limburg, Germany (1998 - 99)
Feasibility study for upgrading existing areas to class D cleanrooms for GMP compliant manufacture of a new innovative inhaler product
Design review of the ointment area
Pulmotec GMBH (previously known as GGU), Hoechstaedt, Germany (1998 - 2001)
Basic and detail engineering and design and construction management for retrofitting existing storage areas to class D cleanrooms for the manufacture of a new GMP compliant inhaler product, including consultation in the execution of the GMP compliant special purpose machines, storage planning, packaging, laboratory and utilities, require-ment specifications, risk analysis, design qualification, installation qualification and operational qualification for plant qualification, appointment of a temporary Technical Manager
Marien Apotheke, Prien, Germany (1998 – 2000; 2006 - 09)
Basic and detail engineering and design and construction management for the retrofitting of existing pharmacy rooms to class D cleanrooms for the separate manufacture of homeopathics and cytostatic drugs, including new ventilation and air conditioning technology and plant qualification
Regular particle monitoring in the cleanrooms, rescheduling and re-qualification of the ventilation and air conditioning equipment
Grupo Industrial BENAVIDES Ltda., Mexico City, Mexico (1998)
Review of the existing processes and factories for GMP conformity; feasibility study for GMP compliant retrofitting or new construction, alternatively for an existing or a new company premises with production and logistics areas for approximately 90 million packages
SIXTUS Werke, Hausham / Schliersee, Germany (1997 - 99)
Basic and detail engineering and design for GMP compliant retrofitting of manufacturing and packaging area of pharmaceutical and cosmetic production in Hausham, construction planning for retrofitting under current production, creation of functional specifications, contract specifications and quotation proc-essing for all building service installations, project coordination and site supervision of all the sections in the retrofitting phase
ASTA Medica Ltda., São Paulo, Brazil (1997 - 98)
Feasibility study for the construction of new premises at São Paulo with production and logistics areas for approximately 50 million packages annually, in-cluding laboratory and administration building for approximately 250 employees, canteen, energy supply and ancillary areas (construction volume approximately 30 million US$)
Natura, Ind. de cosméticos Ltda., São Paulo, Brazil (1996 - 97)
Process reengineering, basic engineering and design of the production and logistics areas to achieve optimum GMP compliant processes in the five new Natura factories (600 million units annually, construction volume 100 million US$).
Natura is Brazil’s largest manufacturer of cosmetics.
Schering-Plough, Indústria Farmacêutica, Rio de Janeiro, Brazil (1995 - 97)
Structural analysis, conceptual and basic engineering (production of solid mate-rial,semi-solid, liquid and sterile products) to achieve optimised GMP compliant processes in the existing plant (approximately 70 million packages annually)
Aché Laboratórios Farmacêuticos S.A., São Paulo, Brazil (1994 - 97)
Process reengineering of all manufacturing processes (in the production of solid, semi-solids and liquids products, antibiotics and sterile products), capacity planning, design of processing equipment, personnel flow, material flow and factory layout to achieve optimum GMP compliant processes for a new plant for approximately 90 million packages annually, concept design of the new production building (construction volume approximately 90 million US $).
Grupo Aché is Brazil’s largest pharmaceutical manufacturer.
Bagó Laboratorios S.A., Buenos Aires, Argentina (1994)
Feasibility study and report on GMP compliance of the existing four pharmaceutical plants of Bagó S.A.; development of new optimised and GMP compliant production structures and processes.
Roemmers S.A., Buenos Aires, Argentina (1992 - 96)
Process reengineering, concept and basic engineering and design, capacity planning for machinery, staff and space, layout development, quotation processing and machine selection of the entire plant facility of the factory “Pharma 2000” for approximately 35 million packages annually of solid pharmaceuticals. Designing and engineering of the areas weighing, granulation, pelletising, coating, capsule filling and packaging (construction volume approximately 55 million US $).
Roemmers is Argentina’s largest pharmaceutical manufacturer.
Woelm Pharma, Eschwege, Germany (1993)
Planning, layout development and execution supervision of the GMP conversion for semi-solid products
MSD Sharp & Dohme, Bad Aibling, Germany (1991)
Engineering, qualification and validation of the compressing plant