- Analysis of production process and specifications for achieving the required degree of protection for product and operator
- Identification of process layouts and analysis of critical points
- Determination of contamination classes of affected areas according to international standards (GMP – FDA – ISO)
- Planivolumetric study of the building and determination of energy needs
- Analysis of necessary machinery and utilities
- Development of preliminary design and economic analysis of investments
Services
A complete package of services tailored to your needs
- Analysis of production processes
- Definition of material and personnel flows
- Process layout
- Identification of air contamination control issues according to required classes
- Study and sizing of air conditioning and filtration (HVAC) systems and utilities
- Study of electrical, control, supervisory and safety systems
- Definition of suitable materials for civil finishes with low particle release infrastructure
- Drafting of specifications for contracts
- Detailed executive design of air conditioning systems, electrical systems, automation and supervision systems, civil infrastructure
- Issuance of technical specifications and material requirements
- Job order planning, control and management
- Construction management
- Supply and implementation of turnkey facilities
- Planning, coordination and management of contract and site work
- Technical supervision and construction management
- Resource management and job order cost control
- Plant startup and balancing
- Testing
- “as built” documentation
- Electrical and HVAC system certifications
- Class certifications according to ISO 14644
- Performance of IQ-OQ-PQ Validation Tests
- Preparation of operating manuals
- Operation service and scheduled preventive maintenance
- Technical service and spare parts
- Staff training courses on cleanroom operation and behavior
- Consulting in the drafting of SOPs