Article | May 22, 2023

Set Up A Single Use System For Success: Part 2

By John Hatzis, Global Life Sciences Industry Consultant, Rockwell Automation, and Pete Genest, Former Strategic Technology Partnerships Leader, Cytiva

Automation: The Future Of Medical Device Manufacturing

In Part 1 of this blog, we made the case for small and mid-size biological producers to adopt a modern distributed control system (DCS) as they incorporate single-use systems in their facilities. It’s an approach that makes an impact both in the present and the future by creating a more flexible operation that can scale up or down with ease. We already explored how the right DCS choice affects two areas:

  • Network infrastructure by simplifying connections and providing seamless data access
  • Operational flexibility by reducing the effort involved in tech transfer and process development

We’ll finish exploring the benefits by covering four additional areas that can help you meet regulatory requirements, reduce validation effort, incorporate newer digital technologies and analytics, and lower your total cost of ownership.

Technology standardization

The more that customized technology and functionality is designed into a single-use facility, the more that specialized knowledge is required for design, operation, and maintenance activities. This requirement for specialized knowledge should prompt producers to establish and leverage standards as much as possible.

Standards such as the International Society of Automation’s (ISA) ISA-88 (1), ISA-18.2 (2), and ISA-101 (3) help create a consistent design approach across multiple pieces of equipment for functions, including procedural control, alarm management, and human-machine interface (HMI) style. These standards can be easily enabled when configuring modern control systems using commercial off-the-shelf software libraries. By using these class-based libraries, equipment vendors can create application-specific software with less time and development cost.

These libraries also smooth the way for those who inherit equipment — such as validation teams, process engineers, and support technicians — because the software is lower risk, provides consistent information, and is easy to maintain.

The libraries also include standard data structures for specific classes of devices, such as pumps, valves, and others. These data structures provide the basis of constructing analytics for equipment, helping producers increase process performance or equipment uptime in the long run.

Operator experience

The user experience of operations staff is too often left out of automation projects. But producers should consider prioritizing the user experience of the control system if they want to create a more efficient workforce. Libraries of reusable class-based objects can be used to create a common user interface style for staff, for instance. For example, a valve will look and feel the same on a tangential flow filtration skid as it does a bioreactor.

Producers should also ensure their visualization system leverages industry standards, such as ISA 101 (3). The standard can help draw operators’ attention to adverse process conditions to help make sure these conditions are seen and dealt with quickly.

Disruptive technologies

New technologies are changing how people work in a single-use facility — perhaps none more so than augmented reality (AR). How can producers apply technology such as AR in a meaningful way in facilities? The best way to find out is for automation engineers to meet with process engineering and operations teams to discuss needs and potential risks that the technology can address.

For example, single-use consumables can require operators to make hundreds of sanitary and aseptic connections during setup. One wrong connection can lead to a costly batch loss. By performing this work in an AR environment, an operator can confirm each connection and reduce the potential for mistakes.

In another scenario, production operators may not have a view of an HMI when they are performing activities such as pumping media, which can result in missing critical alarm notifications. It may be beneficial for operators to wear an AR headset while doing this work so they are more likely to see alarms as they happen.


Mitigating cybersecurity risks is a priority for most biologics producers today. A robust cybersecurity approach can help producers protect their sensitive regulatory and process data, while realizing the many benefits of digitalized operations.

Part of this approach involves designing a control system with standards like ISA/International Electrotechnical Commission (IEC) 62443 (4), which is a consensus-based cybersecurity standard for automation. The standard establishes that multiple layers of protection will provide the most redundancy in case a specific security layer fails. This concept is referred to as a defense-in-depth strategy and spans personnel knowledge and awareness, physical security, application, and device security. Some control systems are now certified to this standard.

Common Industrial Protocol (CIP) security-enabled control devices offer another layer of protection. CIP Security is an extension to the CIP from the automation industry association, ODVA. It uses data authenticity, integrity, and confidentiality to protect against attacks on industrial communications. Industrial asset-management software can also provide recovery and automatic back-up capabilities that are critical following a security incident.

Easing the journey to production

A modern, scalable and flexible control system offers a pragmatic approach to developing an automated single-use facility. With the right design choices, this architecture can help producers create a connected, information-driven facility that scales and evolves with their business.