When CSL Behring wanted to automate its pH measurement processes, Endress+Hauser provided the company a complete solution. It helped the plant not only get the latest solutions but also meet required GAMP compliances. In fact, automated measurement modules are key to an overall automated pharma production at highest standards...
CSL Behring is a global leader in the plasma protein biotherapeutics industry. The company produces therapies to treat rare and serious condition. Also, it aims at improving the quality of life of patients worldwide. The company’s products are indicated for the treatment of coagulation disorders and immune deficiencies as well as for intensive care and wound healing.
The company required an automated pH measuring system for each of three production tanks for a new plasma protein production plant located at Marburg, Germany. These systems were essential to provide process measured values with high accuracy and meet the stringent demands of regulated production. Once the company approached Endress+Hauser with its challenges, the processes were examined in detail.
After the examination and understating requirement, the following components were offered to the company for each of its systems:
- A sterile retractable assembly including pH electrode and transmitter
- pH process valve unit with control unit
- PLC controller with separate control panel and integrated logging functions
- Buffer supply for long operating times
From Standard Components to new Technologies: Solution Used
Once the CSL Behring placed an order of these solutions, an automated pH measuring point was developed based on the functionality of the Topcal system. The measuring point is no longer controlled by an individual transmitter, but rather by a controller with versatile programming functions.
The Pharmcal system combines standard components from E+H’s product portfolio with new solutions. The solutions included a slightly modified retractable assembly CPA475 with a CPS71D Memosens sensor and a process valve unit for managing the media, which is pneumatically controlled by pilot valves in the cabinet.
Integrated Automation for Pharmaceutical Production
While the hardware was being assembled at Endress+Hauser’s plant, the controller was programmed and tested by the company. A Siemens S7 PLC is used to control each system. The PLCs are installed in a protective enclosure with the Liquiline M CM42 transmitters.
A Panel PC SPC350 with touchscreen is used to operate the pH measuring system in the production room, whereby specific program sequences can be started by the process control system. The software was programmed to control the components in accordance with Good Automated Manufacturing Practice (GAMP) guidelines and also supplied the hardware components.
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