The modular production part consists of areas for the preparation and aseptic filling of Pharma into ampoules and syringes. In addition, there will be areas for washing, sterilisation, distribution and HVAC (climate control).
The modular building is placed inside a facility provided by the customer. The facility shall be designed to meet the requirements and guidelines of PIC/S and EMA GMP.
The project will be implemented by a project team with participants from several different companies, which places high demands on coordination and communication.
Several parts of the plant are supplied as stand-alone equipment and communicate with the main process control system, requiring great care in requirements specification and purchasing.
Working with clients with both linguistic and cultural differences creates major challenges for the project team.
The solution consists of a stable and flexible solution that is also easy to control and monitor.
- PlantVision has developed a system solution where GMP critical control is combined with non GMP critical control in a Siemens PCS 7 system with batch control.
- The batch-controlled pharmaceutical process and HVAC run in separate PLCs but are presented in a common operator interface.
- The operators have two touch-based panel PCs located in a clean room environment where they control the process and an operator station where they can create and edit recipes and control the plant.
- Together with the project team, we have created and developed a complex pharmaceutical process that is quality assured and ready to be shipped to Saudi Arabia.
- The modular solution and the use of the Siemens SIMIT simulation platform allowed all development and FAT (Factory Acceptance Test) to be carried out in-house.
- The customer gets a pharmaceutical process with great flexibility that enables the production of a wide variety of Pharma.