Setting the standard: MTP technology and its impact on life sciences production
Author : Reinfried Kößlbacher, COPA-DATA
26 April 2024
Module Type Package (MTP) is being considered for inclusion in an international standard for automation engineering. Here, Reinfried Kößlbacher, Area Sales Manager at COPA-DATA examines what this production methodology means for life sciences manufacturing in relation to customised medicines, ease of engineering and regulatory compliance.
MTP is a modular production methodology that is revolutionising life sciences. MTP was initially coined by the User Association of Automation Technology in Process Industries – also known as NAMUR – and provides a framework for the standardisation of production modules. Explained simply, MTP creates interoperability; the ability to reconfigure production modules and enable modular manufacturing.
MTP is suitable for a range of industries, including food and beverage, automotive and other general processing sectors. However, pharmaceutical manufacturing is where the practice has garnered the most attention. Drug developers are under increasing pressure for shorter times-to-market, while demand for customised and small batch products continues to grow. In fact, the EU is increasingly pushing the development of personalised medicines in a bid to improve public health, with 28 individual policies promoting customised medicine implementation.
As such, MTP provides a suitable solution to meet the changing needs of the sector. But, how exactly is MTP achieved using the zenon MTP Suite?
Achieving interoperability
The basic requirement for modularisation is a uniform description of each individual production module. In pharmaceutical production lines, this could describe everything from encapsulation machines, right through to sterilisation equipment and the individual components involved in packaging processes.
Each one of these production modules must speak the same language, regardless of the age, manufacturer or communication protocol of the machine. This interoperability means that modules are readable in a standardised format with a common description of capabilities. At this point, they can be integrated into the Process Orchestration Layer (POL) – at COPA-DATA, this is referred to as zenon POL.
zenon POL interlocks with the zenon Engineering Studio – an innovative platform to host engineering projects – which in turn, creates the control system automatically by drag and drop of the process modules, and connecting them using the mouse cursor.
At COPA-DATA, we prioritise openness and interoperability in our open DCS (Distributed Control System), facilitating seamless communication between hardware components in modular systems. This includes older legacy equipment that may still be in operation in pharmaceutical plants. These systems can be made MTP-capable with an integrated zenon Logic service, meaning that they can be integrated without any additional programming effort.
Compliance for pharma
Crucially for the life sciences sector, MTP can also improve compliance with regulatory standards. Among these is the VDI/VDE/NAMUR 2658 standard for Automation Engineering for Modular Systems in the Process Industry. This is used in the MTP Editor, a graphically-guided tool within the zenon MTP Suite, that makes it easy to create and edit MTP files. This is supported by a real-time validation service that ensures VDI/VDE/NAMUR 2658 compliance of all newly-created MTP files.
Data integrity is also a consideration covered by the MTP Suite. The process equipment assembly (PEA) Software Suite allows operators to visualise and control their automation projects. This presents a user-friendly HMI that features ISA-88 batch control and audit trails, all while ensuring data integrity in accordance with the FDA 21 CFR Part 11 and Annex 11 of the EU GMP guidelines.
Setting the MTP standard
The MTP Suite from COPA-DATA complies with all necessary regulations for the life sciences sector. What’s more, should a New Work Item Proposal (NWIP) submitted to the International Electrotechnical Commission (IEC) go ahead, MTP could become part of an international standard itself.
The NWIP submission in October 2019 suggests the adoption of MTP as the international standard IEC 63280: Automation Engineering for Modular Systems in the Process Industry.
The push for a standard to promote the adoption of MTP reflects an industrywide desire for improved standardisation. If the transition goes ahead, the life sciences industry will experience streamlined engineering with no need for programming skills, faster time-to-market and improved global access to collaboration.
More information on the zenon MTP Suite here.
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