The activity is based on the following steps:
- Production process and specifications analysis to achieve the degree of protection required for the product and for the operator,
- Identification of process layouts and critical point analysis,
- Areas classification according to international standards (GMP-GLP-FDA-ISO),
- Planivolumetric study of the building and determination of energy requirements,
- Definition of necessary systems, equipment and utilities,
- Development of the preliminary design and investment costs analysis.
The activity is based on the development of what is produced during the feasibility study:
- Analysis of production processes.
- Analysis of materials and personnel flows.
- Process Layout.
- Identification of air contamination control issues according to required classes.
- Study and design of air conditioning and air filtration systems (HVAC) and utilities.
- Study of electrical systems, automation, supervision and safety.
- Definition of suitable materials for civil finishing with low-particulate release components.
- Drawing up of material specifications for procurement.
All basic engineering activities are developed and completed both in terms of documentation (expert reports, technical and dimensional calculations) and design, in order to enable operators to implement the facility.
At this stage, the following documents are defined:
- Executive detail design of air conditioning systems, electrical systems, automation and control systems of the civil infrastructure.
- Technical specifications and material requirements.
- Project planning, cost control and project management.