Pharma Company Meets Standards for 21 CFR 11 with Ignition

When Bachem Americas needed a system for human-machine interface (HMI) and supervisory control and data acquisition (SCADA), it required one that could not only improve its processes, but also satisfy requirements from the United States 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 pharma and biotech industries, specializing in development and manufacturing of peptides and complex organic molecules as active pharmaceutical ingredients, as well as innovative biochemical products for research purposes.
Bachem Americas has two sites in California, in Torrance and Vista. The Vista facility needed a control system for a specific step in the manufacturing of a peptide. The new HMI/SCADA system is for the cleavage operation, which involves separation from a resin support, precipitation, filtering, and drying of the peptide. For this project, Bachem selected the Ignition software platform. Ignition by Inductive Automation® is an industrial application platform with numerous tools for building solutions in HMI, SCADA, and the Industrial Internet of Things (IIoT). Bachem worked with system integrator Wunderlich-Malec Engineering (WME). WME, based in Eden Prairie, Minn., is an employee-owned firm specializing in electrical and control systems engineering and integration services. For Bachem, WME built a custom application in Ignition that satisfies the FDA requirements. The new system also saves money with its unlimited licensing, and improves troubleshooting, which can be done from a laptop. Bachem’s Ignition system includes a data historian, trending, alarming, audit trails, and more.

Low-Cost Expansion

“Bachem picked Ignition because it’s easy to expand. It includes all the features Bachem wanted in a single software package. If you pick any other software, they all have something missing. For example, some of them are missing alarm notification, and you’d have to go with a third party. But Ignition has all the features that you want for pharmaceutical projects, and for meeting the FDA standards.”

Fred Zaboli, senior control systems engineer at WME

Tim Tran, site manager for Bachem in Vista, said Ignition was the clear choice.

“We picked Ignition because it can be described in one word: simplicity,” he said. “It eliminated a lot of the complexity that we saw in other systems that we reviewed.”

“We were looking for a software package that’s easy to operate, and also easy to roll out to the whole site in the future and be compatible with all the existing systems. With Ignition, we are able to have that. And we especially like the compliance to CFR Part 11.”

Rudi Kuehnel, process engineer for Bachem

With Ignition’s unique licensing model — no extra fees for more tags, clients, 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-efficient for this project. As a project manager, I was very impressed with the capability of Ignition in terms of validation and startup and factory acceptance testing. 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.”

Fred Zaboli, senior control systems engineer at WME

Bright Future

Bachem also needed easy access to an audit trail, both for internal use and outside auditors.

“Audit trails are very important in the pharmaceutical industry. With Ignition, it’s easy to activate. On other platforms, you have to do a lot of engineering and programming ahead of time.”

Fred Zaboli, senior control systems engineer at WME

Bachem has also seen benefits from improved reporting.

 

“The reports and data from Ignition are very simple to retrieve and comprehend,” said Tran. “Overall, the experience with Ignition has been great.”

Easy integration with Microsoft Active Directory was another plus.

“The Ignition system uses Active Directory for its authentication, which is part of 21 CFR 11. With other software, they use generic accounts and passwords, which is not part of 21 CFR 11.”

Anthony Chong, senior systems engineer for Bachem

Bachem has been very pleased with Ignition’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. We are looking forward to expanding the system, and we already have some projects in mind. For example, using some utility functions and integrating them into our process, to give operators more control over what’s happening outside of their process room. We see a lot of opportunity at Bachem with Ignition. It’s a platform that makes it possible to do almost anything.”

World’s Largest Yogurt Plant Thrives on Ignition

 

Chobani produced its first cup of Greek yogurt in 2007. Not long after that, Chobani became the top Greek yogurt brand in America. The award-winning company has achieved much notice for its rapid rise, innovative ideas, and quality products. In 2012 the company opened the largest yogurt-manufacturing facility in the world. Located in Twin Falls, Idaho, the plant has been expanded twice already, and it now covers 1.4 million square feet. In late 2017, Chobani broke ground on a third expansion in Twin Falls, for a $20 million global research and development center.

Chobani is based in Norwich, New York, and employs more than 2,000 people. In addition to Idaho, the company has plants in New York and Australia. To help keep production running smoothly, Chobani has been leveraging Ignition software for years. Ignition by Inductive Automation® is an industrial application platform with integrated tools for building solutions in human-machine interface (HMI), supervisory control and data acquisition (SCADA), and the Industrial Internet of Things (IIoT).

All Aboard

Chobani uses Ignition at all three of its plants — on filler and packaging lines, for quality control, in asset management, with enterprise resource planning (ERP), and in capital-expenditure project management.

 

“Ignition has really taken Chobani by storm. Once we brought Ignition onboard, it opened up a new world for us.”

Hugh Roddy, vice president of global engineering and project management for Chobani.

 

That includes access to data that Chobani never had before. With Ignition, Chobani can see data from the plant floor all the way up to the executive level.

Ignition has helped Chobani improve efficiency and reduce downtime.

 

“Once we took Ignition onboard as one of our enterprise platforms, everything has improved exponentially across the board from an operational standpoint”

The company firmly believes in sharing data with its employees.

 

“Our people, they want to be involved. They want to be part of what we’re doing here at Chobani. Having the data from Ignition at their fingertips really helps our employees be more efficient, and it makes them feel part of the team.”

Ignition also aids the convergence of operational technology (OT) and information technology (IT).

 

“Ignition allows us to integrate our OT and IT environments into one.The single platform creates numerous efficiencies. Ignition has been a very good bridge for OT/IT collaboration. We’ve been able to make gateways available to both networks, so whether people are in the office making decisions or on the plant floor making decisions, IT and OT information are both available.”

No Limits

Ignition’s unlimited licensing means that organizations don’t have to pay extra for additional tags, clients, users, or projects. Unlimited licensing has helped Chobani keep up with rising demand for its product.

 

“Because of the unlimited licensing with Ignition, we can roll out as many clients, as many places as we want, whenever we see the need.”

John Furby, automation engineer for Chobani.

One advantage is the ability to set up a single HMI for a special need. In one example, Chobani used this capability for a specific location within its new plant.

 

“Previously, operators were having to use a radio to call in, and have someone start each step of the process for them. With Ignition, we’re able to have a special HMI out there, just for them. Ignition makes it really cost-effective to do a one-off scenario like that.”

Trevor Bell, Chobani automation engineer

Without the typical licensing issues, Chobani can implement new projects much faster.

 

“With Ignition, we’ve been able to roll out several different projects more aggressively to get data to the operators on the plant floor more quickly.”

Chobani also likes Ignition’s ability to speed up the development process.

 

“Whenever we can save time in developing an HMI and implementing it, it’s really valuable for our team. Customization is easier as well. Ignition gives us a software system that we can actually develop to our own. The template development in Ignition is especially easy. We can make custom data types and custom graphics that we can easily roll out to all of our projects.”

Mobility Too

 

Ignition has also freed up operators so they can roam the plant and still have access to data on phones and tablets.

 

“Ignition has given us the ability to be mobile on the plant floor. Our operators and maintenance people don’t have to be running back to the control room. From anywhere, we can control a valve or a pump, and get full visualization of what’s happening in the plant, from raw receiving all the way through packaging.”

 

With Chobani constantly innovating, it needs flexible software that can grow with it. Ignition is a key ingredient for the future.

 

“We believe Ignition gives us endless opportunities here at Chobani. We’ve partnered with INS for five years, integrating Ignition across our sites around the world. With INS and also Tamaki Control working with us on Ignition, it’s really brought remarkable results for us here, in a very short period of time.”