How process simulation can be implemented into engineering programs for the pharmaceutical industry
By Kathryn Pomeroy, Actemium TorontoFeatures Actemium pharmaceuticals process automation simulations
Within the industrial automation industry, there has been an increase in the use of custom process simulation as engineers work to refine or create manufacturing automation for their clients. In the process of upgrading mechanical solutions to automated systems, simulating that same system can save on time and costs, and facilitate the decision-making process when it comes to committing to large overhauls of existing systems.
A professionally executed simulation can offer a better visualization of the end-product that an automation engineering firm is promising, affording the client more confidence as they work through details and make key decisions. It is important to note that simulations cannot replace field testing and system commissioning, but they can facilitate project execution with lower environmental impact. They may also contribute to lower total project cost, project time, testing time, rework, and allow increased review by the client’s non-technical team members to collect as much input as possible. The combination of simulated processes with field testing is what makes for a winning pairing.
The scope of a simulation is usually proportionate to the complexity of the associated project as well as the expectations of the customer. A small, less complicated process will not get as much value out of a simulation and could be an unnecessary expense. Also, if the need for extensive field adjustment and tuning of hardware contributes to most of a product’s cost, a complicated simulation may not be as valuable to the customer. In the case that a system is a layered sequence of operations, then the customer will appreciate the opportunity to review the sequence of steps and actions in detail at their leisure.
For the pharmaceutical industry, manufacturing processes are often complex and thus benefit from simulation. Pharmaceutical manufacturing processes are also subject to tighter restrictions, documentation, testing, and specifications in comparison to other industries, so change at any point in the planning process can incur large costs and delays. Simulation works to soothe these concerns by providing clients with the maximum amount of information and insight.
Part of the consultation process
Simulations function as an accompanying piece of content in the overall consultation process. Typically, an engineering firm or automation consultancy builds a functional, field testable solution and presents it to the client with the relevant parties in attendance. In execution, this presentation of a completed system occurs towards the end of a project’s development timeline, when rework can be expensive. Running and presenting simulations can take away the stress of this commissioning and presentation since issues can be identified and addressed earlier in the consulting process. It opens more avenues of feedback from the client, up front which can aid in catching mistakes, changes, and addressing evolving concerns.
Simulations gain value from being reviewed by key individuals and groups within the client’s organization. Those reviewers may have a background in automation but may also have expertise in other areas of the client business. They may be centrally located, and simulation reviews may be reviewed by a co-located group, but it is equally likely with current business operations that, once recorded, the program simulation videos can be reviewed by geographically separated groups and in drastically different time zones.
Consequently, it is vitally necessary to understand what each of these groups find most interesting or essential with respect to the simulated process. If irrelevant data is presented to a client, those reviewers have no avenue to provide their valuable input and achieve streamlined project costs and timelines.
For this reason, simulation programmers need to understand the processes to identify which parts require particular focus and which can be simplified:
- Are there fast, intricate process steps which should be slowed down so that reviewers can understand and review minute, short-duration details?
- Are there long, monotonous process steps which could be sped up and skimmed over to make the most out of a reviewer’s time and attention?
- When is it a good idea to demonstrate alarm conditions or process interruptions, instead of a smooth uninterrupted manufacturing process?
The best automation engineering consultancies will determine the most relevant information by combining their expertise and experience, to provide their clients with the best review session possible.
As previously mentioned, incorporating simulation into the consultation process is of particular benefit to pharmaceutical projects. Specifications, documentation, and testing play a significant role in the success of any pharmaceutical project. The further the execution of the project schedule progresses, the more complicated any new, unplanned changes become. Documents may have to be re-updated, and there could be impacts to related pre-existing systems, physical hardware complications, wiring concerns, and a need for re-testing of the commissioned system.
Simulations are not valuable if they are not reviewed, so both the development team and the customer must be available to comprehensively review the material and make informed decisions.
All of these can contribute to operational costs and timelines, which could further delay future work depending on the systems in question. Modifications of any kind are rarely made on a whim, so when requested following a simulation review, it is with the understanding of their impact and of their importance for project success. However, implementing changes earlier in the project equates to more efficiencies.
In terms of the overall project timeline, programming and reviewing simulations can affect the schedule by adding in a few milestones, such as:
- Time to program the simulations
- Time to record the simulations
- Time for customer to review simulations
- Time to review comments by customers
- Time to action the reviewer comments
To ensure the least delay possible, there needs to be a strong partnership between the development team and the customer project team. If the project manager works effectively with the development and customer teams, it may only add a few weeks to the project’s schedule. It is often possible for simulations and recordings to begin before all the project’s programming has been completed, as well as before all documentation and clean-up has been performed. Therefore, while simulations do take time, the delay to the project overall is usually minimal.
In some cases, the extension of a development schedule is acceptable, especially when the alternative is the extension of the commissioning period. That is to say, a change which would have been needed if it was found during commissioning or simulation phases is better found during simulation, where the cost is lower as less has been solidified for a given project.
Simulation can be beneficial even for expeditious projects, as it can be prioritized for the most sensitive sections of a manufacturing program as laid out by the customer. Then, the consulting firm can utilize experience with related processes and projects and leverage simulations to generate data for sample production reports, screen captures, operator training materials, and other project documents.
Cost is worth it
When a project involves simulation, there will inevitably be an increased time-cost due to the need to program the simulation code. However, simulations can be kept simple to ensure most of this cost goes towards generating a quality representation of the system and cultivating valuable review material.
Simulations are not valuable if they are not reviewed, so both the development team and the customer must be available to comprehensively review the material and make informed decisions. For a medium-sized control system, simulation is likely to add a couple of weeks to the development phase where the programming is partially complete before the system would move on to factory-acceptance-testing. It is important to note that some of this testing is work that programmers would already be carrying out, to check their own work, but a simulation allows the client to confirm that the programming meets their needs ahead of formal acceptance-testing.
This time-cost is offset by the value it brings to the customer. For customers in the pharmaceutical industry specifically, they enjoy fewer late-stage changes which could incur extra documentation, validation re-work, and cascading changes in other interconnected automation systems.
The earlier a change or correction is made, the lower the cost and time to the client. Additionally, the earlier a process is refined to its final state, the earlier the client can finalize documents for validation, SOPs (standard operating procedures), internal documents, and interactions with other systems within the facility.
Not without limitations
Simulations are not without their risks and limitations. There exists a cost-benefit balance for the work, which can be disrupted by overly complicated or unrealistic programming. If a simulation doesn’t sufficiently represent the real world, then the effort expended on it could be seen as wasteful. If a simulation becomes too complex and the programmer requires an inordinate amount of time to generate video captures of the simulation, then the input of work may not match the value of the outputted convenience.
A programmer focusing on the simulation of activities with less relevance to the customer also contributes to wasted time, so the best practice must involve balanced expectations between the developer and the customer. It is best to keep simulations only as complicated as the process requires. For example, complicated differential calculations for simulating reactor thermodynamics might seem valuable for certain projects. However, if the programmer and the customer cannot justify that development load, it may instead be more valuable to employ simpler, less intensive calculations and refine final system tuning during commissioning.
It is also possible for the customer to have unrealistic expectations regarding the effectiveness of a simulation, or for the simulation environment to be idealistic. Most applications don’t warrant video-game physics-engines, as the cost of developing a custom simulation which mirrors real-world behaviour would be much higher and likely outweigh the benefits.
Ultimately, the simulation process still requires an effective partnership between the developers and the customer to achieve the best results for everyone involved.
With optimal use and conditions, simulation of processes can help the developer and customer identify issues and experiment safely earlier in the project timeline. It also enables more effective collaboration within the client organization, as more people can view and understand the process without having large teams fly out to presentations.
In the pharmaceutical industry, even small changes to automated processes can have expensive, time-consuming consequences. Simulating these processes affords the client increased foresight and the ability to work proactively and keep costs and schedules tight.
Kathryn Pomeroy is an Automation Project Manager with Actemium Toronto. She’s responsible for managing the full project life cycle and delivering quality integration services to meet customer project deliverables.
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