ENGINEERING
- Feasibility study
- Integrated design of manufacturing units and hospital departments, including architectural, civil, plant, instrumental, documentation and certification services
- Production departments by controlled contamination
- Mini-environments with Hydrogen Peroxide sterilization
- Air conditioning systems
- Laminar flow, work stations, special equipment for decontamination
- WFI, DIW, PW, HPW distribution, storage and production plants.
- CIP and SIP plants
- Preparation, storage and sterile filtration automated lines for injectable solutions
- Fermentation and cellular growth automated lines
- Equipments and machines for production and controlled contamination
- Food liquids filtration and distribution automated lines, with CIP and SIP functions fully automated
PLANT
Realization and installation of fermentation plants
Project, realization, supplying and installation of mobile walls, specific ceilings and fan filter units (autonomous units composed by HEPA or ULPA filter, fan and regulator for constant air flow) of our design for environments to controlled contamination.
Supplying and installation of complete cleanrooms up to ISO 4 class, included design and realization of the environmental parameters control plant (air conditioning, refrigerating and thermal plants, electric and signal systems, supervisions systems).
Work stations supplying, laminar flow, mini-environments and special equipments design by our engineering section on customer specification.
PRODUCTION
Proclea’s production capacity is guaranteed by a series of partnership and corporate agreements with companies already on the market individually specialized in the various manufacturing activities needed to realize what we designed.
The production network thus realized which can ensure a turnover of more than 11 million euros (2007 datum) and a working contemporaneity of about 70 people, it consists of companies specializing in:
- Aluminum processing
- Panels processing and assembly
- Stainless steel and aluminum light carpentry
- Heavy carpentry
- Piping realization and mechanical installation
- Company of pure installation
- Specialized company to process validation and pharmaceutical plants
The choose to operate with a network, as well as being a worldwide reality that operate in plant, offer to customer a big flexibility advantage: none of the services listed above is mutually constrained and therefore the customer can freely choose to avail of only one or all of proposed services, containment costs, lower fixed costs and maximum update of production equipments.
VALIDATION
Validation performance are performed by an internal specialized group of Proclea, able to cover all the excursus of project-related documentation:
- Validation Master Plan
- Conceptual design
- Design validation
- Commissioning protocol
- Installation qualification protocol
- Operation qualification protocol
- Performance qualification protocol
- For all field operation related to validation test, Proclea’s certified instrumentation is used
WFI and PW / HPW Production process and distribution systems.