By Pete Genest, Strategic Technology Partnerships Leader, Cytiva
…Lately this has become a popular question, with digital capabilities and automation emerging as a hot topic in the biomanufacturing community.
Before I dive into the answer - which deserves more than one or two sentences - let me define what we mean by ‘automation’ because the term can mean very different things depending on the context. To me, there are two types of process ‘automation’:
Type 1 is System Level Automation, a controls system and user interface that can operate a specific unit operation or single piece of equipment like a bioreactor or chromatography skid. System level automation can exist as a standalone piece of equipment or equipment that is part of a larger control environment.
Type 2 is Platform Level Automation, which is the layer above the system level automation, and includes Type 1 automation. Platform level automation serves as a single-user interface terminal that simplifies processes for the human operator. This type of automation allows the operator to view, monitor, or manipulate multiple systems, often with a single username/password and with a common look and feel to the interface. Control of the system level units can be either centralized or distributed.
I have had a few customers say, “We don’t need automation” or, “We don’t see the value in automation.” However, when customers tell me this, they are usually referring to Type 2: Platform Level Automation or a centralized automation solution. Usually that individual feels that they can operate with standalone systems or what is commonly referred to as ‘islands of automation.’
What can connecting ‘islands of automation’ do for me?
Imagine trying to operate a bioreactor completely manually, without an automated control system. Your inner monologue might sound something like this:
Agitate, pH is decreasing, add some base, not too much….DO is decreasing, add some sparge air…DO isn’t responding fast enough, add some oxygen, overshoot DO…How is pH? Need to add some base soon...how is DO?
With all these factors to manage, your lab floor would soon be reminiscent of that episode of I Love Lucy when Lucille Ball is in the chocolate factory and completely loses control of the whole batch!
To avoid this barrage of impossibly manual tasks, the industry has unanimously accepted the idea of operating process equipment in a GMP environment with Type 1: System Level Automation.
But why add a centralized automation platform? If you have islands of automation, you could have equipment from as many as six or seven different vendors. Even with well-written specifications, you will end up with operators having to learn six or seven different interfaces with different looks and different feels. That leads to the large problem of having six or seven different data historians each with different interfaces to sort and pull data from.
Centralized automation can pull all of this information together without human intervention. It saves time for the already strapped manufacturing engineer. It also results in a myriad of cost savings, depending on your opex structure, including:
- Assembly of data for a manufacturing deviation investigation (going to one historian instead of multiple)
- Efficiency of a single sign-on in a 21 CFR Part 11 compliant system
- Efficiency for operators and IT admin to learn/monitor/maintain one system
Still not convinced? I like to look at this this way – with today’s complex manufacturing systems and processes, can a manufacturer afford to not have a centralized automation platform?
About the author
Peter C. Genest
Strategic Technology Partnerships Leader, Cytiva
Peter earned his Bachelor’s degree in Chemical Engineering at Villanova University in 2003 after which he held technical and manufacturing positions at Wyeth (now Pfizer) and lead engineering roles at Integrated Process Technologies (now Lewa). In 2009, Peter moved to Xcellerex, a single-use technology/services company, acquired by Cytiva. At Xcellerex and then Cytiva, Peter was the lead solution architect and subject matter expert on the FlexFactory product offering, providing global technical and sales support to grow FlexFactory-related business. Now with the Automation & Digital group within Cytiva, Peter promotes the group’s offerings and capabilities in developing new and innovative customer solutions.