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Life Sciences

MTP and Plug and Produce: Why Visibility Needs to Move with the Modality

By
Team Kinetic-ID
Jul 29, 2026
4 min read

Key takeaways

  • MTP (Module Type Package) standardises how process modules integrate at the control layer: the Process Orchestration Layer reads the MTP file and auto-generates the HMI, alarms, and interlocks, removing custom engineering for each module.
  • What MTP does not standardise is the physical access point where operators interact with that data. Control-layer integration is not the same as visibility at the point of work.
  • In a modular environment, the process location moves between campaigns, so a fixed terminal that suited one configuration may be poorly placed after the next. The visibility gap follows the process.
  • The POL re-integrates a changed module layout automatically, but does nothing to relocate physical access points. That stays a separate deployment decision.
  • GMP-rated mobile workstations (ID-Flow 5 and 6 for Grade C/D and B/C; ID-Flow 9 and ID-View for fixed Grade B and critical zones) give the physical layer the same flexibility MTP brings to the control layer.
  • Seamless data connectivity at the control layer is a solved problem. Point-of-work access at the floor layer still needs deciding, and revisiting every time the process changes.

Walk into a facility running a modular process configuration, and the floor looks different from the fixed-plant environments that defined pharmaceutical manufacturing for most of the last century. Process modules, upstream bioreactors, buffer preparation units, and filtration skids are arranged not as permanent infrastructure but as configurable assemblies, connected and orchestrated through a central software layer. When production requirements change, modules are reconfigured or substituted, and when a new product is introduced, the line is restructured instead of having to be rebuilt.

The Module Type Package standard, specified in the VDI/VDE/NAMUR 2658 guideline series and built on NAMUR's NE 148 requirements for modularising process plants, provides the engineering foundation for this flexibility. International standardisation is underway as IEC 63280, and the ISPE Pharma 4.0 Plug and Produce working group is carrying the approach into pharma. 

An MTP file packages everything a process module needs to be integrated:

  • HMI template
  • Data objects
  • Alarm definitions
  • Communication services

When the module is connected to the Process Orchestration Layer, the POL reads the MTP file and generates the operator interface, alarms, and interlock configurations automatically, without bespoke engineering work for each integration.

This is a real shift at the control architecture level, and an increasingly well-demonstrated one. The engineering time required to connect a new module to a production environment falls substantially. The barriers to reconfiguring a production line, which in a traditional fixed-plant environment involve months of validation activity and custom integration work, are reduced to something closer to a scheduled engineering exercise. The ISPE 2026 Europe Annual Conference in Copenhagen placed Plug and Produce and seamless data connectivity together as a paired theme for good reason: the data connection between modules is what makes modular reconfiguration operationally viable, and MTP is the standard that makes that connection predictable.

Pharma Factory Floor Worker

What MTP Standardises, and What It Doesn't

The MTP specification is explicit about its scope. 

‍It standardises the description of a process module's functions and interfaces at the control layer: how the module communicates, what data objects it exposes, how its HMI is structured, what alarms it generates, and how it integrates with the Process Orchestration Layer via OPC UA. 

That standardisation removes the primary friction point in modular automation, the custom engineering required each time a new module enters a production environment. What MTP does not standardise is the physical access point through which an operator interacts with the data those modules generate. This distinction tends to be overlooked in the planning conversations around MTP deployments, because the POL handles the integration automatically and the operator interface is generated as part of that process. The implication, if the architecture is examined only at the control layer, is that visibility is solved: the data flows, the HMI is generated, the alarms are configured. But an operator interface that exists in the POL is not the same thing as an operator interface that is positioned where the operator is working. 

When the Process Moves, the Visibility Gap Moves With It

In a fixed-plant environment, the criticism of fixed terminal deployments is well-established. Operators must leave the process to access the MES or DCS, documentation happens retrospectively and from memory, and the distance between the event and the record of it is a consistent source of data integrity failures and deviations. The argument for point-of-work visibility, bringing the data access interface to the operator rather than requiring the operator to come to the interface, is a response to that fixed-architecture problem.

In a modular environment, the same problem exists, but with an additional dimension. In a fixed plant, the process location is stable, and the terminal placement decision is made once. In a modular environment, the process location is variable: modules are repositioned, production campaigns change, and the operator's working position shifts accordingly. A terminal that was correctly placed relative to the process in one configuration may be poorly placed in the next, and the reconfiguration of the automation layer, handled cleanly by the POL reading the new MTP file, does nothing to relocate the physical access point.

The visibility gap, in other words, does not stay in one place in a modular environment. It follows the process.

Production configuration What the POL handles What requires a physical decision
Module added or substituted Reads the MTP file and automatically generates the HMI, alarms, and interlock configuration. Where operators access that interface relative to the module's position.
Line reconfigured for a new product Updates the orchestration logic and data model automatically. Whether the terminal arrangement reflects the new working positions.
Module relocated within the facility Re-integrates the module into the POL without custom engineering. Whether the visibility infrastructure moves with the module or stays fixed.

The Process Orchestration Layer handles the integration problem at the control layer. It does not relocate the visibility infrastructure to match where operators are now working.

What It Looks Like in Practice

Consider a biopharmaceutical facility running a modular upstream processing configuration. The process modules, a seed bioreactor, a main bioreactor, and a tangential flow filtration skid, are positioned in a production suite and connected to the POL via OPC UA. The MTP files have been loaded, the HMI is generated, alarms are configured, and the integration is complete. The automation layer is working as designed.

The fixed MES terminal sits at the entry end of the suite, positioned when the facility was originally commissioned for a different production campaign. During the current run, operators are working primarily at the bioreactor and the TFF skid, both at the far end of the suite. Parameter logging happens from the terminal, which means operators are periodically leaving the process to document it. An alarm fires at the TFF skid during a filtration step; the operator at the skid is not within line of sight of the terminal and does not see the alert for several minutes. So, while the MTP integration is handled automatically, the visibility at the point of work is not.

When the campaign ends and the suite is reconfigured for a different product, a faster process, or a different module arrangement, the TFF skid is repositioned closer to the entry, the POL re-integrates the changed configuration automatically, but the terminal stays where it is. Depending on the new layout, it may now be better positioned or worse, but the decision of where to place physical access points is not part of the MTP reconfiguration workflow. 

The Questions Automation and Digital Manufacturing Teams Should Be Asking

For automation engineers specifying MTP-based environments, the gap sits between the control-layer integration plan and the physical deployment plan. The POL architecture diagram will show how modules connect and how data flows. It will not show where operators stand when they are managing those modules, how far they are from the nearest data access point, or whether the terminal arrangement will remain appropriate after the first reconfiguration.

The practical questions worth building into the specification:

Question What you're checking
For each process module, what is the operator's primary working position and how does it relate to the nearest MES or POL access point? Whether the terminal placement was designed around the operator's working position or placed for engineering convenience.
When this configuration is changed, a module substituted or a line restructured, does the visibility infrastructure adapt, or does it stay fixed while the process moves around it? Whether visibility is treated as a fixed asset or a deployable one across reconfiguration cycles.
If mobile workstations are part of the deployment, are they GMP-rated for the environments the modules will operate in, and do they support hot-swap battery architecture for continuous use across shifts? Whether the hardware specification matches the cleanroom grade and operational continuity requirements of the modules.
Is the assumption that a generated POL interface, visible on a terminal somewhere on the floor, constitutes effective point-of-work access, and is that assumption being tested against how operators move on the floor during a production run? Whether control-layer integration has been conflated with floor-level visibility.

For digital manufacturing teams, the MTP and Plug and Produce architecture is often positioned as the pathway to seamless data connectivity across modular production lines. That connectivity exists at the control layer. The floor-level question, whether that data reaches the operator in a form they can act on at the moment they need it, depends on the physical access infrastructure.

Visibility Infrastructure in Modular Environments Needs the Same Flexibility as the Process

The MTP standard enables a production architecture where process modules can be reconfigured without extensive re-engineering of the control layer. That flexibility is well-demonstrated at scale across pharma and biotech deployments, and it is one of the reasons modular manufacturing has moved from a pilot-stage concept to an operational reality. But the architectural thinking that applies to process modules does not automatically extend to the physical infrastructure through which operators access it.

Mobile workstations for life sciences manufacturing, GMP-rated, designed for cleanroom environments, equipped with hot-swap battery systems that support continuous deployment across shifts, are the physical layer that can match the flexibility MTP introduces at the control level. The ID-Flow 5 and ID-Flow 6 bring MES, POL, DCS, SCADA, and LIMS access to Grade C/D and Grade B/C environments on a mobile platform that moves with the operator and with the process. The ID-Flow 9 and ID-View extend that to fixed Grade B and critical zone positions where in-room access is required but a mobile unit is not appropriate. In facilities where the process configuration is expected to change, which is, by definition, any facility built around the Plug and Produce model, relying on fixed terminal placement in the areas that keep changing is a constraint that compounds with every reconfiguration.

Seamless data connectivity at the control layer is a solved problem. Point-of-work access at the floor layer is an infrastructure decision that still needs to be made and in modular environments, it needs to be revisited every time the process changes.

If your workstation infrastructure isn't part of your modular deployment plan yet, here's how we can help

Kinetic ID builds GMP-rated mobile and fixed workstations for life sciences manufacturing environments, from Grade D processing areas through to Grade B fill-finish suites. The ID-Flow range covers mobile deployments with hot-swap battery architecture and validated stainless steel construction; the ID-View covers fixed in-room access. Our solutions team can walk you through the product options, grade requirements, and deployment configurations relevant to your MTP and modular production environment.

Speak with a solutions consultant

Frequently Asked Questions

Plug and produce is an approach to modular manufacturing in which individual process modules, such as bioreactors, filtration skids, or buffer preparation systems, can be connected to a central orchestration system and made operational without custom integration engineering. The Module Type Package standard, specified in the VDI/VDE/NAMUR 2658 guideline series and based on NAMUR's NE 148 modularisation requirements, provides the technical foundation. Each module carries an MTP file containing its HMI template, data objects, alarm definitions, and OPC UA communication configuration. When the module connects to the Process Orchestration Layer, the POL reads the MTP file and automatically generates the operator interface and integration logic. This allows production environments to be reconfigured more quickly than traditional fixed-plant designs, with less re-engineering between campaigns.
An MTP, or Module Type Package, is a standardised file that describes the functions and interfaces of a pharmaceutical process module at the control layer, independently of the module's manufacturer or underlying automation platform. It contains the information needed to integrate the module into a production environment, including operating screens, data objects, communication services, alarm definitions, and OPC UA endpoint configuration. When imported into the Process Orchestration Layer, the MTP enables automatic generation of the operator interface and interlock configuration, removing much of the custom engineering otherwise required for each integration. MTP is central to the ISPE Pharma 4.0 Plug and Produce initiative and is increasingly used in facilities pursuing modular and flexible manufacturing architectures.
In a modular environment, process modules can be repositioned, substituted, or reconfigured between campaigns, meaning the physical location of production work can change. Fixed data-access terminals, including MES workstations, DCS interfaces, and POL HMI displays, do not automatically move with the process. Operators may therefore end up further from the nearest documentation or monitoring interface after a reconfiguration, reintroducing documentation delays and slower alert response. MTP integration provides seamless connectivity at the control layer, but it does not relocate physical access points. Mobile workstations positioned at the operator's working location, and moved as the production configuration changes, help close this floor-level visibility gap.
The Process Orchestration Layer, or POL, is the central software platform that coordinates process modules in an MTP-based modular production environment. It reads MTP files from individual modules, also known as Process Equipment Assemblies, and automatically generates the operator interface, alarms, and interlock configuration needed to operate them as an integrated production line. The POL communicates with each module through OPC UA, the communication standard that supports MTP connectivity. Because it can read and integrate MTP files without custom engineering for every module, the POL enables the Plug and Produce principle. It manages automation and control logic, while the physical infrastructure through which operators access the system remains a separate deployment decision.
Point-of-work visibility means placing data-access infrastructure where operators perform the work, rather than requiring them to walk to a fixed terminal. In a modular environment, this principle has an added requirement because the location of the process changes between production campaigns. An access point that works well for one configuration may no longer be appropriately positioned after a module is moved or the line is restructured. GMP-rated mobile workstations that can move with the operator and the production configuration provide a form of point-of-work infrastructure that matches the flexibility introduced by MTP and Plug and Produce at the control layer.

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References

  1. NAMUR NE 148. Automation Requirements Relating to the Modularisation of Process Plants. https://www.namur.net
  2. VDI/VDE/NAMUR 2658. Automation Engineering of Modular Systems in the Process Industry (Part 1: General Concept and Interfaces; MTP core specification, with international standardisation underway as IEC 63280). https://www.vdi.de/en/home/vdi-standards/details/vdivdenamur-2658-blatt-1
  3. ISPE Pharma 4.0™ Plug and Produce Working Group. Concept Papers. Pharmaceutical Engineering, May/June 2024. https://ispe.org/pharmaceutical-engineering/may-june-2024/pharma-40tm-plug-and-produce-working-group-publishes
  4. ISPE. Pharma 4.0™: Plug & Produce Architectural Principles. https://ispe.org/pharmaceutical-engineering/white-papers/pharma-40-plug-produce-architectural-principles
  5. ISPE 2026 Europe Annual Conference. Featured Topics: Plug & Produce and Seamless Data Connectivity. Copenhagen, April 2026. https://ispe.org/conferences/2026-europe-annual-conference/featured-topics
  6. COPA-DATA. Module Type Package. https://www.copadata.com/en/industries/process-manufacturing/mtp-modular-production/mtp-insights/module-type-package/
  7. Profibus & Profinet International. MTP – Module Type Packages. https://www.profibus.com/technologies/mtp
  8. Honeywell Process Solutions. Modular Automation: The Plug-and-Produce Opportunity for Life Sciences. https://process.honeywell.com/content/dam/process/en/campaigns/hps/modular-automation--the-plug-and-produce-opportunity/documents/hon-ia-pas-mtp-3327780-white-paper.pdf
  9. Bittorf et al. (2023). Design of Module Type Package Services for Modular Downstream Units and Process Analytic Technology. Chemical Engineering & Technology. https://onlinelibrary.wiley.com/doi/full/10.1002/ceat.202200390