Engineering

User’s requirements specifications
Feasibility studies and project budgeting
Auditing and technical consultancy on plants, process and equipments
Site layout definition and optimization
Concept design
Basic design
Detail design
Procurement assistance
Design review (e.g. value engineering, GMP review, HSE review)
Construction management
Safety management
Translation of technical documentation

Commissioning and Validation

Validation Master Planning
Design Qualification
Risk Management (Impact Assessment, Risk Analysis, FMEA)
Equipment and systems FAT witnessing and coordination
Support to the start-up of plants, equipments and services
On-site commissioning
Equipment and systems SAT execution and coordination
Instruments calibration
Equipment and systems qualification (IQ, OQ, PQ)
Re-qualification activity and periodic checks
Support to Process Validation

Consultancy and Management

Project Management
Project Scheduling
Budgeting and cost control
Technical expertise
Permitting
Technology evaluation and selection
Plant and System Troubleshooting
Calibration and maintenance planning
Vendors auditing
Energy auditing
Regulatory consultancy

Turnkey solutions

Design and construction of cleanrooms, laboratories, critical systems, and controlled-contamination environments for the Life Sciences sector.

In collaboration with Mangini Life Sciences

Target markets

Sterile products manufacturing facilities
Manufacturing plants for active pharmaceutical ingredients (API)
Manufacturing plants for high potency pharmaceutical ingredients (HPAPI)
Biological and biotechnological production facilities
Packaging and warehousing systems
Pilot plants and R&D laboratories
Advanced therapies and regenerative medicine
Diagnostic products manufacturing
Medical devices industry
Radiopharmaceuticals production and research facilities
Process optimization and automation
Energy Efficiency

Most relevant skills

“Bulk” product processing plants
Fill-finish processing lines
Packaging and serialization technologies
Air conditioning (HVAC) systems
Barrier isolator and RABS systems
Clean utilities (PW, WFI, CS, etc.)
Chemical, biological and radiological containment
Process automation
Energy optimization
Bim Integrated design
Paperless validation (Kneat – Tims)
CFD modeling