Johnson & Johnson
Un environnement de production propre et conforme. Garanti.
Dans la production pharmaceutique, les paramètres environnementaux tels que la température, l’humidité, la pression atmosphérique et les niveaux de particules doivent s’inscrire dans des limites précises. Dès qu’une valeur est hors limites, le système de surveillance de l’environnement (EMS) donne l’alerte. Il n’est donc pas étonnant que le site Johnson & Johnson de Limerick ait voulu maintenir son EMS à jour et en conformité avec les réglementations de la FDA et de l’EMA. C’est précisément à ce niveau qu’INDEFF est intervenu.
Johnson & Johnson
A clean and compliant production environment. Guaranteed.
In pharmaceutical production, environmental parameters such as temperature, humidity, air pressure, and particle levels have to remain within precise limits. As soon as any value is out of range, the environmental monitoring system (EMS) sounds the alarm. No wonder, then, that Johnson & Johnson’s Limerick plant wanted to keep its EMS up to date and in line with FDA and EMA regulations. And this is where INDEFF stepped in.
Efficient system implementation
The EMS update was part of a larger project: the upgrade of the manufacturing control system to AVEVA System Platform. The EMS consists of Allen-Bradley PLCs with an integrated AVEVA Historian system that records all data.
Thanks to INDEFF’s standard library with test and functional design documentation as well as engineering tools, our engineers saved precious development and testing time. In addition to the software, INDEFF also installed the remote I/O panels with PLC hardware – connected to monitoring devices in the field.
More efficient alarms and logs
With the new EMS running in the plant, Johnson & Johnson now has multiple alarm systems that detect environmental issues. This means that operators can more easily validate the clean status of labs and production areas. And as there is a central repository for alarms, system operators require less interface time to locate and evaluate incidents.
In addition, AVEVA Historian provides a full audit trail of every event and action logged on the EMS. It allows users to access historical process data, alarms, and events. These logs are necessary to ensure compliance with FDA and EMA regulations. Ultimately, the EMS guarantees that Johnson & Johnson keeps producing its pharmaceuticals in the most secure manner possible.
Phased implementation approach
Validating and implementing the system on-site required careful planning and resource management. Indeed, a phased and flexible approach was necessary to overcome the different schedules on which equipment and people were working.
Due to equipment availability on-site, our engineers had to be ready for deployment at short notice. We facilitated this to great success, with our well-known flexibility, ensuring a smooth installation and validation process.
Goals
- Update EMS and manufacturing control system
- Allow for efficient assessment of production environment issues
- Guarantee compliance with FDA regulations
Challenges
- Tight timeline
- Scheduling implementation and testing
- Strict regulations in pharmaceutics
Results
- More detailed monitoring of environmental parameters
- Operators require less interface time to assess alarms, improving operator efficiency
- Full audit trail of actions logged on the EMS