SIGMA Process & Automation GmbH

Process automation is our DNA

Plasma Fractionation – New Plant Construction


We were decisively involved in the design, implementation, and documentation of the required production, cleaning, and sanitization processes during the construction of a new plant for the fractionation of human plasma. The plant areas included both discontinuous production systems and continuous systems for the supply of high-purity and auxiliary media. Both special equipment from various manufacturers and numerous package units were integrated into the overall project and linked via the function specifications.

The holistic aspect of our work becomes particularly evident in this project. We successfully provided guidance and support to our customer throughout, from consulting for the qualification concept for particularly high efficiency and safety to the influence of our process experience in the function specifications to the performance of operational startup and the start of production on site.

Scope of performance:

  • Creation of the physical and procedural model in accordance with ISA-88 of the plants with more than 40 piping and instrument diagrams and several thousand actuators/sensors
  • Preparation of the function specifications (>800 phases, parameters, alarms, interlocks)
  • Creation of more than 50 formulas
  • Creation of the batch reports
  • Support in the preparation of the qualification concept
  • Support of software FAT, operational startup, and qualification

Project duration:

  • 48 months (with interruptions)

Number of employees involved in project:

  • 6