Success story
Synthon Hispania – Pharmaceutical Control
- Implement a redundant control system for monitoring and/or controlling all machinery and technical fluid and energy installations that are critical to the plant.
- Develop a flexible, open, and scalable tool that facilitates the integration of other systems and manufacturers (Eurotherm, Fycometal, Circutor, etc.).
- Guarantee the stability of critical parameters for production processes, as well as their traceability, and protect records from unauthorized access.
- Allow the management of facilities from any computer in the plant, without the need to go to the specific PC.
- Generate a coexistence of a control and supervision system for general services (office air conditioning, boilers, cooling units, etc.) and another for production areas under pharmaceutical standards (production air conditioning, monitoring of environmental conditions, etc.).
- Carry out a phased modification that does not influence the control and monitoring of critical elements during the installation and start-up period.
- Reformulate the technical management system for production areas, warehouses, and offices, which was previously based on a “non-open” tool.
- The access security system for the SCADAs should be based on the same users as the IT infrastructure of the entire plant.
- Distributed control system, capable of integrating all the elements involved, with an improvement in monitoring and maintenance.
- At the same time, a data server that allows centralizing all plant information to be viewed from any SCADA or external application.
- Redundancy between systems for rapid reaction in the event of server failure or network disconnection.
- SCADA access security system that follows the standard user and password policies of the Synthon plant, complying with CFR21 part 11 regulations.
- Highly scalable solution for future system expansions within the same architecture, without the need to stop the systems already in operation.
Synthon Hispania, S.L. was founded in November 1998, when the group acquired facilities from the Dutch multinational Akzo that its pharmaceutical subsidiary Organon used. The objective was to turn it into the main pharmaceutical production and logistics center, as well as one of its R&D hubs in the galenic phase.
Since then, the company has experienced remarkable growth, mostly due to investments in advanced facilities, to the point of manufacturing 2 billion tablets annually. Production plants, R and quality control laboratories, warehouses, offices… All of them, as expected, required a control system up to the task, capable of monitoring each individual action without losing the overall vision.
Galaxy of Systems
The solution, implemented thanks to the close collaboration between the integration company SistelCONTROL and the engineering and IT departments of Synthon Hispania, is a “galaxy” of platforms, engines, and automation objects, with a relational database.
This galaxy is configured as a distributed control system, capable of integrating all the previous elements, while centralizing all plant information for viewing from wherever it is required. In turn, it gives way to possible expansions in the control and monitoring capabilities of the production plant, without losing the current architecture and quality standards.
Escalation in Terms of Regulatory Compliance: a Favorable Aspect
The new system implemented by the company complies with all the regulatory aspects required by the American Medicines Agency (FDA), which is why the audits carried out by this organization have been successfully passed and it can sell its products in the American market today.
Interdepartmental Fusion of Needs
A large part of the project’s success lies in having managed to cross the needs of the different departments, with a solution of high added value for the company.
