Through the implementation of Wonderware Historian and InTouch visualisation software and the ArchestrA System Platform from Invensys Operations Management, Rottendorf Pharma GmbH has improved the efficiency of its cleanroom operations and process monitoring
For over 80 years, Rottendorf Pharma has been an independent service company with worldwide operations for the development, production and packaging of pharmaceutical products in a solid form. The company develops and produces solid oral medicines for approximately 200 customers, including many global corporations.
Requirements
The production of pharmaceuticals requires compliance with several legal regulations and standards, including the principles of GMP (Good Manufacturing Practice) and GAMP (Good Automated Manufacturing Practice). To be able to respond quickly and cost-effectively to ever changing legal requirements and manufacturing technology conditions, while ensuring high product safety, an integrated quality management system is mandatory. Furthermore, in the production, analysis and storage of pharmaceuticals, specific environmental conditions must be guaranteed. At Rottendorf Pharma, a building control system takes care of this aspect. However, the lack of a control room revealed the necessity of a GMP-compliant room monitoring system.
A specific project was launched to define a system that monitors environmental conditions with a multi-level alarm concept. The pharmaceutical process parameters must be constantly measured and presented in standard reports.
Implementation
To cover the whole spectrum of requirements, among other things, an alarm concept was created to act as a foundation for the design of alarm levels and possible actions and/or operating sequences. With this concept, when alarms are triggered, a room or user-specific notification of the alarm-triggering parameters is sent automatically to department printers, for instance. In addition, standard reports with monitoring and production data are defined and are now generated automatically.
This means that sensor signals are captured via decentralised peripheral devices by a PLC. Here, threshold values are monitored and alarms and escalations are generated. Room signal lamps are activated to signal an alarm in the corresponding room. This is where ArchestrA System Platform comes in and processes data coming from the PLC and a SNMP OPC Server for the monitoring of system components, finally generating the alarms.
Pharmaceutical process parameters for long-term analysis are then recorded in Wonderware Historian and reports are generated accordingly. To visualise the system, the Wonderware InTouch visualisation software is used.
To ensure error-free operation and to have a test environment for expansions, the monitoring system in production was complemented by a quality system with identical functionality.
All system modifications are executed in the quality system and only after successful testing they are transferred to the production system. In this way, all new functions can be developed and tested thoroughly with no impact on the stability of the production system.
Results
With the monitoring system developed by on/off based on Wonderware Software, GMP-critical values such as differential pressure, temperature and relative humidity are measured, analysed and filed continuously. In case of alarm generation due to specification violations, users are notified and provided with smart escalation management instructions.
All system alarms related to failed or defective system components are displayed at a central location, for instance, so that risk reduction and failure removal actions can be performed immediately.
Based on this system and process solution, it was possible to harmonise legal requirements, state-of-the-art science and technology, and individual requirements. GMP-compliant as well as automated systems bring benefits especially in situations where consistently high product quality and flawless monitoring of manufacturing conditions are required.
The adoption of Wonderware Software protects investments in the long term as a result of the creation of a standard system with low operating costs. Additionally, the ArchestrA technology provides the foundation for a scalable system – from a single room to an entire factory – using powerful, reusable and template-based objects. Ultimately, this solution led to the quick and easy qualification of a FDA- and GMP-compliant system.
Invensys Operations Management
T: 01293 526000
