When biochemical company Bachem Americas needed a system for supervisory control and data acquisition (SCADA) and human-machine interface (HMI), it wanted a single platform that could not only improve its processes, but also satisfy requirements of the U.S. Food & Drug Administration (FDA). The FDA’s Title 21 of the Code of Federal Regulations Part 11 — also known as 21 CFR 11 — establishes rules for the use of electronic records and signatures, covering authentication, confidentiality, integrity, availability and more.
Bachem is a leading biochemical company based in Switzerland, with facilities in Europe, Asia and the United States. The company provides services to the pharmaceutical and biotech industries, specializing in development and manufacturing of peptides and complex organic molecules as active pharmaceutical ingredients, as well as biochemical products for research purposes.
Bachem Americas has two sites in California, in Torrance and Vista. The Vista facility needed an HMI/SCADA system for a specific step in the manufacturing of a peptide. This was the cleavage operation, which involves separation from a resin support, precipitation, filtering and drying of the peptide. For this project, Bachem selected Ignition by Inductive Automation, an industrial application platform for building solutions in HMI, SCADA and the Industrial Internet of Things (IIoT).
This software platform is based on open standards, which made numerous functions flow smoothly. "The SCADA system platform was simple to understand," said Tim Tran, site manager for Bachem Americas in Vista. "The communication with various devices and equipment was very easy. The reports were very simple to retrieve and comprehend."
Rudi Kuehnel, process engineer for Bachem, described it as an innovative approach and modern. "It’s very open, as a system. You can configure it as you want it," Kuehnel said. "What we appreciate most is the monitoring, trending and control capability. It gives us control over the whole system, and it’s easy to use."
The software has also improved troubleshooting capabilities. Operators can access the system on a laptop, from anywhere in the facility — that includes full access and control. The system also includes a data historian, trending, alarming and audit trails.