It is pretty clear that automation can improve efficiency, track performance and liberate operators from mundane routines. But with it comes cost and time factors around customization, communication and validation. So, the challenge is not just how to automate, but how to do it well.
Using a ‘plug-and-play’ approach can greatly enhance the benefits of automation. By standardizing the communication framework, it can substantially cut the time and effort needed to implement equipment in a flexible, single-use technology environment.
Think of it this way: if the ‘ballroom’ concept of facility design provides the space, plug-and-play automation makes it easier to switch partners in the biomanufacturing ‘dance’.
This is why the BioPhorum Plug-and-play project team has been working hard to move the industry from unique and custom software developments to a reusable, standardized approach allowing the quick integration of intelligent process skids.
A standard approach
As you might expect, the team is basing its approach on existing standards. These are principally ISA S88, ISA S95 and the open platform communications uniform architecture, OPC-UA.
It is also working with an organization called NAMUR, to develop and adopt its Module Type Package (MTP) approach to plug-and-play. NAMUR is an international user association for automation technology in process industries, so its members can draw on and share learning from across different industries, maximizing the quality of the guidance they produce.
In the MTP approach, an assembled piece of equipment undertaking a unit operation in the manufacturing process (a ‘skid’) is classed as a ‘module’, for which a minimum set of input and output parameters is defined. Each module can be identified, and its structure and input/output needs recognized, by the system controlling the process.
Core to the work is finalizing a single-use bioreactor interface specification. In trials, this allowed a technical team of four equipment manufacturers and three control systems suppliers to successfully perform interconnectivity tests using MTP files. In one case, a bioreactor in Molsheim,France, was remotely operated by a control system in Frankfurt, Germany.
Steve Miller, Director BioContinuum at Merck, said that when the team met in Frankfurt, it was a very positive and productive event. “The team moved forward on several fronts: plug and play for biopharma in general, approaches to GMP compliance and the interface specification for a single-use bioreactor. Our guests from NAMUR seemed impressed with the team’s ability to cover a lot of ground and align on pragmatic solutions to keep advancing the project.”
The team is also dovetailing into NAMUR’s standards development process. This follows a path into the VDI German standards body and then through to the International Electrotechnical Commission, which publishes international standards for all electrical, electronic and related technologies.
Using a plug-and-play architecture can lead to significant cost savings, as illustrated in the table:
|Activity/function||Estimated person-hours saved||Estimated schedule reduction||Estimated cost savings|
|Interface integration design, development, implementation and testing||300+ hours||2–3 months||$60–80k|
|Tools to help detect, diagnose or help facilitate communications||20–60 hours||2–6 weeks||$5–25k|
|Troubleshooting communications||30–80 hours||3 weeks||$15K|
|Workarounds and diagnostic tools||20–40 hours||2 weeks||$8k|
|Licence cost of third-party solutions||16–20 hours*||1 week*||$2–8k|