- By Bill Lydon
- May 14, 2021
Bill shares his observations of the recent BioPhorum MTP (Module Type Package) standard Plugfest days, where users and vendors collaborated moving towards the goal of achieving plug-and-play equipment interoperability for the biopharmaceutical and other industries. The user and vendor participants in the PlugFest were highly professional and focused on positive outcomes.
I was an observer at the recent BioPhorum MTP (Module Type Package) standard Plugfest days, where users and vendors collaborated moving towards the goal of achieving plug-and-play equipment interoperability for the biopharmaceutical and other industries. The user and vendor participants in the PlugFest are highly professional and focused on positive outcomes, and their progress was farther along than I had originally thought.
I was impressed with the progress and success of the remote testing approach required by the realities of the pandemic. This approach for the early stages of plugfests for other industrial technologies has a great deal of merit to save time and money.
When I observed the three different days of the PlugFest, I was also impressed by the process and BioPhorum PP05 facilitator Julian Goy’s skills and experience. My assessment is based on my training and experience as a Value Engineer and trained as a creative problem-solving group facilitator at the Creative Education Foundation, University of Buffalo. A group facilitator’s job involves managing the creative and problem-solving process of a group to improve how it operates and resolve issues, increasing the group’s effectiveness.
The BioPhorum vision
The BioPhorum’s vision is to develop the guidelines for Module Type Package (MTP) files to be used with modular equipment commonly found in biopharmaceutical processing. to achieve plug n’ play dramatically reducing engineering labor, lowering project execution time, and increasing quality. At the heart of Plug and Play is the VDI/VDE/NAMUR 2658 standard that defines the Module Type Package (MTP). The objective of BioPhorum’s plug-and-play concept is to effortlessly integrate intelligent unit operations in the S88 procedural batch engine of the overlying supervisory automation system of a Good Manufacturing Practice (GMP) compliant facility.
The “Module Type Package” (MTP) focuses on creating standardized non-proprietary descriptions of modules for process automation. MTP advancing the concepts of ISA88 and ISA95 into an open vendor independent plug-and-produce models that include attributes including alarm management, safety & security, process control, HMI and maintenance diagnostics. OPC UA is used as the way to communicate Module Type Package (MTP) data between systems.
MTP also focuses on addressing common complaints users have when vendors deliver various pieces of equipment that do not directly and intelligently communicate with control, automation, asset management and business systems requiring significant investment to integrate into plant operations. Today, the addition of hardware, software and application engineering for interfaces to integrate these decreases system reliability and increases lifecycle maintenance cost.
PlugFest advances BioPhorum Mission
This PlugFest contributes to the BioPhorum mission to create an environment where the global biopharmaceutical industry can collaborate to accelerate their rate of progress, for the benefit of all. The organization has over 108 member companies with over 3,700 leaders and subject matter experts participating. Major goals of the organization include:
Bringing leaders together to create future visions that focus industry’s energy on key emerging opportunities.
Mobilizing communities of the top experts around opportunities, up and down the biopharma value chain.
Creating partnerships that enable change and provide quickest route to implementation and results.
Replacing isolation with collaboration so that the industry shares, learns and builds the best solutions together.
The BioPhrum global collaboration is a vehicle for change with industry leaders and experts working in concert to deliver results by pooling knowledge, practices and ideas. Currently, the BioPhorum organization has eight Phorum initiatives:
- Development group drug substance
- Fill finish
- Information technology
- Supply partner
- Cell & gene therapy
The Plug and Play Workstream is an example of the many subgroups that support the Phorum initiatives.
Having been involved in various industry organizations and standards groups over the years, I find the dedicated professional BioPhorum facilitators an innovative approach to achieve goals and outcomes. The role of the BioPhorum facilitators:
Always present: BioPhorum facilitators are focused; never deflected by competing job priorities as volunteer’s
Neutral with no agenda: They have just one boss–their team, and one goal–their team’s mission.
Guardians of collaboration: ensuring equal contributions, open debate and facilitating solutions.
Process managers: Constantly designing and adjusting the way teams interact, share, debate and build solutions for effective collaboration
Situational leaders: Always understanding the needs, the community’s energy and thinking how to move the engagement onto the next level of industry value.
Remote connections to systems and equipment at different physical locations which normally would be in a single plant were used to communicate and verify operations. This innovative use of technology during the pandemic to accomplish tasks illustrated that a significant amount of progress can be made without the cost of all participants in a plugfest being in one location. The remote communications were obviously slower, but testing the transferred information, logic and operations was effective. In the future, anyone doing a plugfest should consider this efficient method for the first stages of testing.
The PlugFest, named PP05, was a successful series of tests designed to help the Plug and Play workstream (P&P) build towards public, proof of concept testing, and the commercial launch and use of Plug &Play capability.
The goal of the tests was to run multiple bioreactor services on Process Equipment Assemblies (PEA - e.g. single-use bioreactors, chromatography and filtration unit skids) from three different bioreactor suppliers and stress test. Each set of services were controlled from three different POLs (Process Orchestration Layer). A total of six executions of the services were run simultaneously on two Process Equipment Assemblies (PEA - e.g. single-use bioreactors, chromatography and filtration unit skids).
The three Process Orchestration Layers (POL) testing participants Emerson, Rockwell Automation, and Siemens. Each hosted virtual testing on three separate days. The PEA testing participants were Cytiva, Merck KGaA (LifeScience), and Pall.
Outputs from PP05 include, completed test specification records, .mp4 recordings of the test sessions, and a list of conclusions and next steps. Some issues were identified and documented that will be worked out and this is exactly the value of having a plugfest.
The next goal is a physical Face to Face (F2F) meeting as soon as possible with simultaneous meetings in the US and Europe.
Open Architecture use case
In 2012 I wrote an article, Open Architecture "Use Cases" - the Next Frontier forecasting the next major frontier in the evolution of open architecture is the development of application standards built around Use Cases to increase automation productivity and efficiency. The BioPhorum Module Type Package work is a great example of an open architecture use case centered on pharmaceutical & biotech production.
In software engineering, Use Cases define an application challenge and are the focal point for creating high level structured designs used to build solutions. These solutions solve the stakeholder’s goals of maximizing interoperability, code reuse, quality, and efficiency. A Use Case focuses on the relationship between systems, operators, communications and the overall process that needs to be performed. Functional abstraction is fundamental since it separates purpose of a module from its implementation.
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