Project Highlights Selection
- GD02 Project
Client:
GSK BIOLOGICALS
Location:
Gödöllo, HUNGARY
Completion Year:
2006
Nature of Project:
The project consists in the realisation of new bulk vaccine manufacturing facility on a green field site. The project comprises production building plus site infrastructures. The size of the production building, that includes also the generation of all needed utilities, is 3,500 m² in footprint and 15,000 m² overall surface on 5 levels. The facility will be built on a green field site adjacent to an existing GSK Bio facility.
Scope of Work:
• Basic design endorsement • Detailed design • Procurement • Construction supervision • Commissioning • Validation (IQ/OQ)
- Expansion Of Injectables Facility
Client:
SANOFI AVENTIS CHINOIN
Location:
Miskolc (HUNGARY)
Completion Year:
2006
Nature of Project:
Extension of an existing plant to install a new production line for injectables . The project involves the reconversion of an existing warehouse into new production area organised on 4 levels, the realisation of a new warehouse and the general upgrading of existing utilities and infrastructures. The overall surface of the new areas is of approx. 11.000 sq.m. The construction shall be performed with the site in operation without interruption
Scope of Work:
• Basic Design Review • Detailed Engineering • Assistance to Procurement/Subcontracting • Construction of production area on LSTK basis
- High Containment Pilot Plant
Client:
CILAG AG
Location:
Shaffhausen (SWITZERLAND)
Completion Year:
2003
Nature of Project:
The project foresees the realisation of a new pilot plant in an existing three-storey facility of Schaffhausen. The plant will handle potent drugs and substances, and therefore the main topics will be to set up proper level of containment. An extensive use of isolation technology is foreseen. The project will foresee three different production compartments (one small scale and two medium scale), as well as a number of ancillary functions (solvent storage, equipment storage, weighing of chemicals, offices, preparative HPLC lab, etc.). In particular, the plant foresees: 9 reactors (63, 250 & 400 litres) in three compartments; centrifuge dryer, nutche dryer, centrifuge, dryer; HPLC; Class D environment for production; Ex-proof installation; Use of BUCK Valves and/or Isolator Technology for Workers Protection (High Potent); Separation of Production and Technical Areas; Infrastructure: Process Utilities, Exhaust Air Treatment; the plant shall comply with current GMP rules required by local and international authorities (such as FDA, EMEA, etc.).
Scope of Work:
Conceptual Design Basic Design Detailed Design Procurement assistance
- New Biopharmaceutical Plant
Client:
SHANGHAI WEIKE BIOLOGICAL PRODUCTS CO.
Location:
Shanghai, CHINA
Completion Year::
2003
Nature of Project:
The project consists of a new grass-roots biopharmaceutical complex, with a production building (products are obtained by r-DNA fermentation) and an R&D complex (including an animal house). The facility will also includes offices, amenities, warehouse and other ancillary facilities and infrastructures. Total surface of built area is around 6,000 m². The plant shall be designed and built at the “state-of-the-art” technology for the biotech production and shall be in full accordance with the latest GMP requirements.
Scope of Work:
• Site Master Plan & Conceptual Design • Basic Engineering • LSTK supply of technological parts
- New Galenic Manufacturing Facility
Client:
ROCHE
Location:
Gebze, TURKEY
Completion Year:
2003
Nature of Project:
New grass roots manufacturing facility to replace existing plant for production of OTC and Rx products in oral solid forms, with an overall capacity of 60 MM. sales units per year. Some of the existing packaging and tabletting equipment will be relocated and reutilised. The new facility consists of a new main 4-story building (of about 18,000 m² surface) that is connected to an existing warehouse structure. The new facility also includes a warehouse extension, canteen, QA/QC laboratory, offices, workshops, utilities plant and waste water treatment system. The new plant has been designed to comply with local and EU cGMP regulations.
Scope of Work:
General engineering contractor is providing the following services: • Basic Design • Detailed Engineering • Procurement/subcontracting • Project control • Construction Management • Qualification • Commissioning & start-up of utilities
- Plasma Fractionation Plant GMP Upgrading Project
Client:
BAXTER
Location:
Rieti, ITALY
Completion Year:
2002
Nature of Project:
Upgrading of existing plasma fractionation facility to make it compliant with current GMP’s. The areas to be revamped cover an overall surface of approx. 1,800 m². Within the project, also an extension of the existing building shell is foreseen. The revamping works will be mainly aimed at upgrading the production areas to a class C environment. Some modifications will be foreseen also on the existing process utilities systems (WFI, CIP) and on process lines. Most of the existing process equipment shall be reutilised, even if some will be relocated and some other will be purchased new.
Scope of Work:
• Basic Design • Detailed Design • Procurement/Subcontracting • Construction supervision • Assistance to commissioning • Validation • Coordination of Safety (DL 494)