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Manufacture Bioprocessing - Single Use Systems, Technology and Equipment

The Human Factor

sponsored by Pall Biotech

The business case for single-use systems (SUS) is becoming ever more compellingwith the trend towards flexible manufacturing and the need to get products to market faster. At Pall, we see SUS within our business growing year-on-year as more companies make the switch.

Although the switch from conventional stainless steel to SUS has come a long way, in some cases there is still room for improvement in their design. Good product design must incorporate Quality by Design (QbD) – which ultimately ensures the product is of the right quality at the end of its manufacturing process. In a presentation given by GlaxoSmithKline at the 2019 Disposable Solutions for Global Manufacturing event in Amsterdam, it was said that “QbD is key – no integrity test can replace a bad design.”

But a technology is only as good as the effectiveness of the person who uses it. One aspect of product design that is often overlooked is ergonomics and ease of use. It has been said that human error is responsible for more than 80 percent of process deviations in the pharmaceutical and related manufacturing environments (1), and biocontainer/bag leakage is still described as one of the top factors limiting the adoption of single-use technology (2). Reports have shown that improving the reliability of SUS and reducing the risk of leakage requires many actions, including improving the training of end-users and the design of the single-use systems.

In biopharma manufacturing, the design of equipment should help the end-user to operate the technology correctly, which, in turn, will lead to less errors, reduced chances of contamination, and improved product and process performance. SUS design should be intuitive, easy to use, and consistent – and must take into account that there is a human handling the systems and connecting them. This means considering people’s mobility, height, strength and reach ranges, for example, during design to ensure that systems are not too complex or too awkward to use. Small adjustments to a product design can go a long way to improving a process; for example, did you know that an uncomplicated task at knee level is much more likely to go wrong than at benchtop? Even simple things like bending down a lot or reaching can also be health and safety issues when added together.

Improving usability

There is a lot that biopharma companies can learn about usability from the consumer world. For example, consider the ubiquitous nature of mobile phones. Fifteen years ago, mobile phones could only be used for calls and text messages, but today you can surf the web, order your shopping, control your heating and more. The ease of using a mobile phone and other devices have changed our expectations of technology and we now also expect other technologies in our lives, from refrigerators to cars, to be easy to use and to incorporate smart technology that enhances the user experience. A good user experience should offer a holistic approach, incorporating both the design of the product and its software. Moving into the pharma and biopharma world, we also expect the same kind of user-friendly technology in our personal lives to be applied to the equipment we use in our professional lives; for example, we expect interfaces and equipment control systems to be intuitive and easy to use and, where appropriate, to be monitored remotely via apps.

At Pall, one of our core values is continuous improvement and we use a kaizen approach to improve our products and services. With SUS, there are some very basic principles that we adopt to enhance the user experience. One example is shadow boarding. This is something commonly used in school classes, such as woodwork rooms, where there might be a board showing the shadow of a hammer or screwdriver. If either of these tools were not in place, the student would know instantly what was missing and where it should go once found. It is a simple methodology and it works, so we apply something similar to make SUS installation intuitive. The aim is to ensure that any user can pick up our SUS products and know instantly what to do with it. We also use direct numbering with colour coding on our labelling to help users understand how to install a product. In addition, we have started to embed installation instructions for single-use manifolds on the Allegro™ STR Bioreactor and other hardware user interfaces so the user can look through them at the point of use. This can be useful to verify correct usage, and helps to reinforce training when using the hardware systems.

As one example of how ergonomics can affect product design, consider the Kleenpak Presto sterile connector. When we first started development, we looked at what the users actually needed when it came to connections and worked to understand how they were using current technologies and what the pain points were. We identified error prevention as a very important point – users needed to be sure they had made a successful connection – as well as ease of use, since users would be wearing gloves (sometimes two pairs of gloves are worn in clean rooms) when using the connectors. We also had to be aware of the level of force required to make a connection to ensure that users didn’t experience any fatigue or stress in the wrists and the hands. Biopharma manufacturing is repetitive so you need to think of the strain of repeated use. We knew from analysis of competitor products that some connectors required several different actions and a considerable amount of force to actuate.

We addressed all of these considerations and, through iterative testing with end users, came up with a number of solutions. For example, the Kleenpak Presto sterile connector has a strong visual cue if the connection has not been made successfully, as well as a simple “click, pull, twist” three step operation.

Designing for users

When discussing how to improve SUS, the topic of standardization frequently arises. To use an analogy, everyone would like a standard USB connector for everything. But if Pall and all of its competitors started to make the same USB connectors, then end-users would not get the latest innovations, have less flexibility and possibly need to compromise on using the right equipment for the process. We have, however, standardized our range so that once an end-user has brought into a Pall system, they know exactly what they are getting in terms of performance and ease of use. This helps to minimize training because everything is consistent.

Considering human factors in product design can play a huge role in improving efficiency, consistency, productivity and job satisfaction, while minimizing errors. We have been applying this approach for a number of years now and we have a lot of data that helps to drive design decisions. We don’t just think, “Users may like X and Y”; we have robust data that tells us exactly what users need, that we have addressed their problems – and ultimately this creates value for end-users because people use the equipment correctly, effectively and safely.

User-Centered Design

One key tool used in our product design is UX FMEA (user experience failure mode effects analysis). This enables us to benchmark the current end-user workflow and identify opportunities to make improvements through risk mitigation and process improvements. We do this by forming collaborative, diverse and multidisciplined project teams. User-centered design is part of the tool set where the team will:

Clearly empathize with the user through:

- Interviews

- Shadowing

- Observing

- Research

Define who are the people we are designing for:

- Creating personas

- Understanding their objectives, including the pain points and challenges they face

Generate ideas:

- collaborative, multidiscipline, diverse and inclusive creative sessions

- develop potential concepts and solutions

Prototype early and often to develop meaningful solutions

- Build mock ups and prototypes

- Understand what the final solution could look like

Test prototypes with end users

- Does the potential solution address the customer and end user pain points?

- Do users value the potential solution?

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  1. MasterControl, “Reducing Human Error on the Manufacturing Floor,” (2010). Available at Last accessed November 7, 2019.
  2. BioPlan Associates, “Sixteenth Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production” (April, 2019).

About the Author

Andrew Kit

Director of User Experience at Pall

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