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Implement FDA 21 CFR 11 with Ignition

Bachem Americas uses the advantages of Ignition, which can be optimally connected to existing systems and supports the requirements of FDA 21 CFR 11 in terms of software technology.

When Bachem Americas needed a system for human-machine interface (HMI) and supervisory control and data acquisition (SCADA), it not only needed to improve its processes, but also meet the requirements of the US Food & Drug Administration (FDA). Title 21 of the FDA's Code of Federal Regulations Part 11 - also known as 21 CFR 11 - establishes rules for the use of electronic records and signatures that include authentication, confidentiality, integrity, availability and more.

Bachem Americas has two facilities in California, in Torrance and Vista. The Vista facility needed a control system for a specific step in the production of a peptide. The new HMI/SCADA system is for the cleavage process, which includes separation from a resin carrier, precipitation, filtering and drying of the peptide. For this project, Bachem chose the Ignition software platform. Ignition by Inductive Automation® is an industrial application platform with numerous tools for creating solutions in the areas of HMI, SCADA and Industrial Internet of Things (IIoT).

Cost-effective expansion

"Bachem chose Ignition because it is easy to expand," says Fred Zaboli, senior control systems engineer at WME. "It has all the features Bachem wanted in a single software package. If you choose any other software, they're all missing something. For example, some of them are missing alarm notification and you would have to go to a third-party provider. But Ignition has all the features you need for pharmaceutical projects and to meet FDA standards."

Tim Tran, site manager at Bachem in Vista, said Ignition was the clear choice. "We chose Ignition because it can be described in one word: Simplicity," he said. "It eliminates a lot of the complexity we've seen in other systems we've looked at.

"We were looking for a software package that was easy to use and could be easily expanded to the entire site in the future and was compatible with all existing systems," said Rudi Kuehnel, process engineer at Bachem. "With Ignition we are able to achieve this. And we especially like the CFR Part 11 compliance."

With Ignition's unique licensing model - no additional fees for more tags, customers, users or projects - Bachem can achieve its goals for less money than it would have to pay with other vendors. "Compared to other software packages, Ignition was very cost-effective for this project," says Zaboli.

There are also numerous benefits in terms of functionality. "As the project manager, I was very impressed with the power of Ignition in terms of validation, commissioning and factory acceptance testing," says Kuehnel. "We were practically able to run a simulation on the first day after programming. The simulation helped us troubleshoot before we put the system into production."

Future-proof

Bachem also needed easy access to an audit trail, both for internal use and for external auditors. "Audit trails are very important in the pharmaceutical industry," says Zaboli. "With Ignition, it's easy to activate. With other platforms, you have to do a lot of engineering and programming up front."

Bachem has also seen the benefits of improved reporting. "Ignition's reports and data are very easy to access and understand," says Tran. "Overall, the experience with Ignition has been great."

The ease of integration with Microsoft Active Directory was another plus. "The Ignition system uses Active Directory for authentication, which is part of 21 CFR 11," said Anthony Chong, senior systems engineer at Bachem. "Other software uses generic accounts and passwords, which is not part of 21 CFR 11.

Bachem is very pleased with Ignition's performance and plans to expand its use. "We plan to expand it to the rest of the Vista site, which would be a tenfold increase," Tran said. The company plans to use Ignition for new projects and for upgrading existing projects. Ignition will also be used at Bachem's Torrance facility.

"We are looking forward to expanding the system and already have some projects in mind," Kuehnel said. "For example, we want to integrate some features into our process to give operators more control over what happens outside their process room."

While WME uses Ignition in other industries and environments, Zaboli is excited about how well it works at Bachem and 21 CFR 11. "We see a lot of opportunity with Ignition at Bachem," he said. "It's a platform that allows you to do almost anything."

Wunderlich-Malec Engineering is one of the largest and most established engineering firms in the US. It has been providing engineering, systems integration and manufacturing solutions for more than 30 years.

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