New building for the production and packaging of solid dosage forms and inhalation products.
Customer
Novartis Pharma AG
Location
Stein, Switzerland
Budget
500+ Mio. CHF
Year
5 Years
Mandate
General Planner Process
Services
Project management
Concept study, basic and detailed design
3D planning pure media supply
Construction management
Qualification
Procurement support
Expediting
Document management
Filling line for pre-filled syringes
Planning of a filling line for pre-filled syringes in Switzerland, including planning of all process systems and building infrastructure through to commissioning.
Customer
International Pharmaceutical Manufacturer
Location
Switzerland
Budget
35 Mio. CHF
Year
3 Years
Mandate
General Planner
Services
Project management
Planning for all process systems and entire building infrastructure in existing production building (ventilation, clean room, connection to energy and media supply, incl. EMSR and building automation)
Conceptual design, basic design, detail design
Procurement support, expediting
Support for installation management (conversion during ongoing operations)
Planning and qualification of a complete filling line for vials using isolator technology, including automatic loading and unloading. General planning and qualification of the new system.
Customer
Merz Group Services GmbH
Location
Dessau, Germany
Budget
18 Mio. EUR
Year
2 Years
Mandate
General Planner, Qualification
Services
Qualification concept
Qualification master plan
Risk analysis
Review and approval of supplier documents
Monitoring of qualification (IQ/OQ)
Coordination of qualification (IQ/OQ)
Implementation of PQ
First plasma fractionation plant in Turkey
Planning of a plasma fractionation with 650,000 l / 1 million l (expansion) per year; basic fractionation, purification, fill & finish, products: IVIG, albumin, FVIII, each in different concentrations. Planning as a "sandwich concept", production-centered arrangement with the supply below and HVAC above.
Customer
Maxicells
Location
Isanbul, Turkey
Budget
Confidential
Mandate
General Planner
Services
Concept & basic design (completely 3D)
Tender design (all trades), tender procedures
Investment cost estimation, value analysis
URSs
Preparation of schedules
Procurement support
Software validation of 3D printers
Creation of a CSV framework, an SOP for the software development cycle and a validation strategy for the control software for 3D printers used to manufacture medical devices.
Customer
Anonymous Customer
Location
Confidential
Budget
Confidential
Year
6 Months
Mandate
Consulting
Services
Consulting: GAP analysis, risk analysis, concept development
Computerized system validation: validation plan, specification, test strategy
Operational procedures
New Facility HD15
Planning and execution of a new plant (4 floors) for the production of natural products under high pressure conditions (supercritical CO2 up to 1,000 bar).
Customer
Hopfenveredelung St. Johann GmbH
Location
Wolznach, Germany
Budget
6 Mio. EUR (excl. Engineering Fees)
Year
3 Years
Mandate
General Planner
Services
Basic & detail engineering, support of the procurement process (tendering procedure, contract negotiations), construction management, support of commissioning
Chemical engineering departments: project management, HVAC incl. automation, process planning (building services, packaging unit, piping, 3-D model)
Special features: Process automation of the customer, relocation of existing process equipment (e.g. extraction system)