- By Bill Lydon, Automation.com
- March 21, 2020
By Bill Lydon
The current state of pharma manufacturing maturity and the future of automation in the sector were important topics at the annual Pharmaceutical Automation Roundtable (PAR) held October 2019 at a Novo Nordisk facility.
This group of engineers boasts a wealth of practical knowledge and knowhow and is always willing to share with other participants to create a collaborative learning environment for all. Thus, the PAR meetings represent one of the most knowledgeable groups of automation professionals gathered in one place, at any one time, to discuss automation issues. This article (as with all in the series mentioned in Related Articles, below) presents a summary of the discussions at this meeting. Presentations and comments by PAR attendee members are reported anonymously. Find out more about PAR and the companies involved below.
This year’s discussion revolved around the results of a survey completed by approximately 100 people from 19 pharmaceutical companies around the world. Respondent demographics included:
- Geography: Approximately 60% were from North America, about 30% were from Europe, 8% were from Asia and less than 2% were from South America.
- Age: Approximately 53% were age 35-50; about 30% were over 50; 17% were 35 years old or younger Millennials or Generation Y)
- Level 1 - Predigital - Manual, Paper-Based Processes
- Level 2 - Digital Slices - Islands of Automation
- Level 3 - Connected Plant - High Level of Automation, Integration & Systems Standardization
- Level 4 - Predictive Plant - Integrated Plant Network, Pervasive Real-Time Predictive Analytics
- Level 5 - Adaptive Plant - Plant of the Future, Autonomous, Self-Optimizing, Plug-and-Play
In maturity Levels 1 and 2, the focus is on operations at individual plants. As maturity increases from Level 3 to Level 5, greater emphasis is placed on the plant as part of an integrated network of internal and external plants. This includes the end-to-end value chain that encompasses the patients who are the ultimate consumers and recipients of the medicines manufactured at the plants.
Level 4 maturity, called Predictive Plant, represents the highest level of automation and integration achievable with current technology. Level 5 maturity, Adaptive Plant, is not achievable with today’s technology and requires significant advances not only in digital capabilities but also in manufacturing process, sensor and analytical technology. These advances are described in detail in the BioPhorum Biomanufacturing Technology Roadmap. The Biomanufacturing Technology Roadmap is another important resource.
Packaging LinesSurvey respondents were asked to rate the level of packaging line automation over time. The responses show a shift to more connected plants and eventually predictive operations. A minority (18%) believe Adaptive Plant operations will be achieved in 10 years.
Asked about the maturity level of their newest plants and facilities, respondents indicated that more than 60% were at Level 3 - Connected Plant. Based on responses, the level of automation over the next 10 years of API sites, parenteral filling, packaging lines, and warehouses will increase the levels of automation at similar rates.
|Level 1 - Predigital||Level 2 - Digital Slices||Level 3 - Connected Plant||Level 4 - Predictive Plant||Level 5 - Adaptive Plant|
System ArchitectureSurvey responses related to the state of their current system architectures were as follows:
|Current Situation||Five Years|
|No unified architecture||10%||65%|
|Standardized proprietary architecture||75%||78%|
|Standardized Architecture Using Interfaces Between Proprietary Systems||80%||75%|
|Standardized Open Architecture||7%||58%|
Control System ProtocolsUsers are moving from OPC to OPC UA, but some are now exploring MQTT and MTConnect, according to the survey.
|Current Situation||Five Years|
Process Automation ProtocolsEtherNET/IP is and will remain the main process automaton protocol. In five years, there will still be a reasonable amount of Profibus, Modbus, ProfiNet, HART, and Foundation Fieldbus, according to survey results.
Basic ControlExtinction of sites with “No control or monitoring only” is expected in the next 5 years. The majority of operations are orchestrated by a batch system. In general, in 5 years’ time, expect:
- More operations centralized in one system.
- More simple sequences automated.
- More parameters controller with closed loop.
- More basic operations automated.
Process ControlVirtual servers, MES, and Ethernet I/O are now considered widely used. These are mature technologies that will continue to grow in use. Many believe there will be more intelligent control methods used in the future, including:
- Process Based Event Automation
- Model Predictive Control
- Neural Network Control
- Fuzzy Logic Control
- Gap Control
- Growing use of Electronic Batch Records(EBR) with review by exception.
- Increased automation of product tracking and genealogy.
- Further use of paperless tickets and electronic data collection.
The value of Process Analytical Technology (PAT) is understood but, when compared to alternative investments that increase quality and yield on an existing production line, PAT has lower return on investment, so it is hard to justify. The cost of adding PAT when designing a new production line makes it feasible. Some commented that many of the PAT solutions today do not measure up to the reliability standards of process sensors, which can be a challenge.
Process Analytical Technology
Manufacturing Execution SystemsRelatively no changes are expected in the next 5 years for Manufacturing Execution Systems (MES), except for electronic batch records. MES Functionalities are expected to remain relatively stable in the next 5 years except for increased use for labor management and performance analysis functions.
|Recipe Management||64 %|
|Electronic batch record reports & review by exception||61 %|
|Material Management (material tracking)||59 %|
|Equipment Management (scheduling, status tracking)||57 %|
|Paperless Tickets||48 %|
|Resource Management (people/documents/procurement)||39 %|
Cloud computing is making it possible to do sophisticated analytics, simulation, predictive maintenance, and other functions more easily at a lower cost.
The Pharmaceutical Automation RoundtableThe Pharmaceutical Automation Roundtable (PAR) was founded more 20 years ago by Dave Adler and John Krenzke, both with Eli Lilly and Company. At the time, the purpose of PAR was to provide a means of benchmarking and sharing best practices for automation groups among peer pharmaceutical companies. The group specifically does not discuss confidential or proprietary information, cost or price of products, price or other terms of supply contracts, plans to do business or not do business with specific suppliers, contractors, or other companies.
The PAR meetings consist of various presentations, given by PAR members, on specific automation-related topics. Other members then provide comments about their experience, ideas, and challenges relating to the presented topics. The participating companies in the 2019 PAR annual meeting included: Abbvie, Amgen, Baxalta, Biogen, Bristol-Myers Squibb, Boehringer Ingelheim, ImClone Systems, Lilly, Merck, NNE Pharmaplan, Novo Nordisk, Perrigo, Pfizer, and Sanofi Pasteur.
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