What’s Old is New Again

SCADA system helps Merck KGaA, the world’s oldest pharma firm, meet new European and U.S. regulations at its Merck & Cie plant

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The intuitive user interface means staff only needs a short introduction before effective use of the SCADA system. Various screens show building and floor layouts, providing a quick overview of facility floor plans.

 

Data is logged and monitored in real time. If values exceed accepted levels, users are informed via an alarm. The first step of the alarm system turns on locally mounted alarm lights. In the second step, an alarm signal is given by the alarm server and transmitted to mobile phones using SMS, and also to land-line phones.

Data is also sent to an online SQL database using InduSoft’s patented database connectivity that delivers exceptional speed and reliability. The data archiving to the SQL database historian reduces the load on the GMP SCADA system, allowing for consistent and reliable server performance. Historian data can be represented graphically in historical trends for easy analysis.

The GMP SCADA system is integrated into a GMP network specially built for the project. The GMP network is connected with the office network through a firewall. The security system ensures that only authorized users can make changes to system parameters.

In addition, the GMP SCADA system uses InduSoft Web Studio to provide tools that designate users as individuals or groups, thus restricting access to different aspects of the system. This helps ensure that eSignatures are verified, and that all user actions are recorded for traceability purposes. As a further enhancement, InduSoft Web Studio can be connected to Microsoft Active Directory using the LDAP protocol to provide advanced SCADA security capabilities.

 

CUSTOM MODULES MEET CLIENT CONDITIONS
Custom modules were developed to enable evaluation by the Statistics Report, which displays trends over the course of several weeks or months. These trends offer valuable features such as the number of times value thresholds exceed minimum, maximum and average values.

Production processes and sterilization cycles can be evaluated automatically with the Reference Book module. On the basis of a defined setpoint value, each process is subsequently evaluated based on the template qualification laid out in the Reference Book. An evaluation report is then generated for release along with the finished product.

Representatives of the FDA and EU Annex can easily audit and verify data captured with the GMP SCADA system as all development was done in accordance with GAMP 5 and FDA 21 CFR Part 11 in order to maintain Design Qualification, Installation Qualification and Operational Qualification verification.

 

Clear limits for values and carefully planned guidelines give operators the precise information needed for quality assurance. Operator interface screens use standard colors and graphics to make analysis easy, from historical data and trends to everyday operations. Off-site facility monitoring reduces response time, and the ability to access to the system via existing hardware such as PCs and smart phones saves time and money.

Retel Neuhausen led the project from planning to completion. By purchasing a turnkey solution, Merck & Cie vendor and contractor interfaces were reduced to a minimum, supporting the successful delivery of the SCADA system that now spans the entire facility. Ultimately, the system not only meets tough international requirements, but was also designed to manage future growth and changes. When new technology is introduced or when production processes change, the system will allow for seamless connection to new hardware and easy access to new data.

 

 

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