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.
Bachem worked with system integrator Wunderlich-Malec Engineering (WME). WME, based in Eden Prairie, Minnesota, is an employee-owned firm specializing in electrical and control systems engineering and integration services. The company has 350 employees.
For Bachem, WME built a custom application on the software platform. The application has improved several processes at the site and also satisfies the FDA requirements. The new system also saves money with its unlimited licensing. There are no extra fees for more tags, clients, devices, users, or projects — allowing Bachem to achieve its goals for less money. Based on the value and functionality seen at the Vista site, Bachem has decided to also deploy the software at its facility in Torrance.
“Bachem picked this software because it’s easy to expand,” said Fred Zaboli, senior control systems engineer at WME. “It includes all the features Bachem wanted in a single software package … this has all the features that you want for pharmaceutical projects, and for meeting the FDA standards.”
Better testing, auditing, reporting
In addition to meeting the FDA requirements, the software provides several benefits in functionality. “As a project manager, I was very impressed with the capability in terms of validation and startup and factory acceptance testing,” said Kuehnel. “We were pretty much able to run a simulation on the first day that the programming was done. The simulation helped us to eliminate errors before starting it up in the manufacturing unit.”
Zaboli of WME said, “We developed user-defined tags and graphical templates for each device and each individual process cycle. Then we tested and qualified the whole project in a simulated environment, which helped us reduce the commissioning time.”
Bachem also needed easy access to an audit trail, both for internal use and for outside auditors. “Audit trails are very important in the pharmaceutical industry,” said Zaboli. “With this software, the audit trail is easy to activate. On other platforms, you have to do a lot of engineering and programming ahead of time. With this software, it’s an option. You just activate it.”
Reporting is another area where Bachem saw benefits from the new software. The company’s reporting processes were simplified. Easy integration with Microsoft Active Directory was another plus, since Active Directory authentication is part of 21 CFR 11.
Bachem has been very pleased with the software’s performance, and is planning to expand its use. “We plan to roll this out to the rest of the Vista site, which will be a ten-times expansion,” said Tran. The company plans to use it for new projects and to upgrade existing projects, both in Vista and in Torrance.
Jim Meyers is success manager at Inductive Automation, which creates industrial software that empowers organizations to turn great ideas into reality by removing technological and economic obstacles.