by Kelsey H | May 14, 2024 | Debottlenecking, Process Improvement
Bringing these new products to the commercial market creates a wide range of challenges for leading biopharma manufacturing facilities. Plants operations can often look drastically different once a new commercial manufacturing run is added to production. Our colleague from Sanofi, Jon Forstrom, noted in a recent keynote presentation at the BioProcess International Conference that four in five biopharma plants no longer manufacture the products they were designed for. Instead, they now manufacture other, newer products.
In the second part of our new product development series, we examine ways the manufacturing environment must evolve to accommodate the transition from clinical to commercial manufacturing. We’ll also showcase the way digital twins can provide valuable time and cost saving support to facilities. According to McKinsey analysis, companies who utilize these digital resources to scale up production can see a 25 to 40 percent increase in plant capacity among other improvements in the most critical performance metrics.
Evaluating Supply Chain and Inventory Processes
When it comes time for a site to scale up manufacturing a new biopharma drug, it will be necessary to re-evaluate all elements of the existing supply chain. This could require using an alternate raw material supplier rather than the one used during the clinical phase if they cannot meet the expanded requirements. Depending on the ingredients of the new product, a facility may be able to identify a current supplier able to provide all the necessary materials for existing and new product lines. If a new supplier needs to be sourced, complexities could arise in receiving schedules compounding the initial uncertainty that comes with acquiring a new vendor.
If the vendor list does need to expand and raw materials start to arrive on different timelines, this could also require overhauling the inventory management system to account for the changes. Will supplies for the new drug arrive just as inventory levels for an existing product are at their peak? Does the facility possess the necessary equipment to accommodate the necessary hold times or temperature storage requirements?
With an advanced process modeling tool, planners can easily troubleshoot ways to account for changes in raw material deliveries and unforeseen storage bottlenecks. Planners can adjust the production schedule to relieve inventory pressure or expand the existing storage footprint to accommodate the new influx of materials. The site will also be able to evaluate improvements to their inventory system to handle changing ingredient storage requirements, such as longer hold times or temperature restrictions.
Reallocating Resources for Commercial Production
In addition to acquiring and storing raw materials, it can also be difficult for plants to adapt their processes to optimize the allocation of resources needed for scaling-up new products. Site leaders are often uncertain about how to best adjust labor and equipment schedules to meet the needs of an expanded range of products. If the new product demands a more skilled labor force, human resources may have to invest time to reskill or upskill the existing workforce. Operations leadership might also look to invest in automation to reduce the burden on HR. If the site lacks adequate labor or equipment resources, the plant will need to determine the most optimal production compromise until the shortage can be corrected.
Leveraging a highly accurate, virtual model of a real-world manufacturing plant will provide a greater understanding of main line activities and underlying detailed process dynamics. Because it’s an exact replica of the real site, planners can use the digital twin to test possible changes to best suit the new products. Running experiments with different allocations of labor and equipment can determine the optimal configuration to accommodate the new product. An advanced tool like VirtECS will also identify the most efficient production path to maximize output if critical resources are limited and cannot be addressed immediately.
Adjusting the Production Schedule
Even with all the correct materials and resources in place, facilities often face a lot of uncertainty determining the optimal times to start the various production runs. Planners may try to slate the new product into the various openings presented by the current production schedule. This approach can create unnecessary bottlenecks or challenging changeovers in the overall production schedule. Further, this could decrease run rates, hurt overall plant production output and increase product lead times.
Planners may not immediately recognize the facility is running at suboptimal production because there is a lack of historic data to show what the plant is capable of producing with the new product included. This could force leadership to underestimate how much product can be delivered to market.
Digital twins take the guess work out of production scheduling, even with a new product. Planners will always know the true maximum capacity of their plant’s resources, making it easier to find opportunities to improve the current manufacturing yield and debottleneck production. Consistently identifying and taking advantage of efficiencies in the manufacturing process will lower the overall cost of producing the new drug. Every additional cost-saving effort can often mean the difference between profitability or loss.
VirtECS has been implemented in sites for several global manufacturers to solve their challenges in scaling-up production of new products. In his keynote presentation, Forstrom noted that with the VirtECS digital twin, “We can rapidly simulate scenarios where we fit new products into old plants. Where it would normally take weeks or months to do a full analysis, we’ve turned around some of these analyses with VirtECS in a day or two.” To hear more about Forstrom’s experience using a VirtECS model at Sanofi, you can watch his full presentation here.
by Kelsey H | Jul 19, 2021 | Debottlenecking, Process Improvement
In our line of work, reducing bottlenecks is the name of the game. We know how important it is for successful plants to produce as much output as possible in the shortest amount of time. With this goal in mind, it can be difficult to sacrifice additional run time to keep up with maintenance tasks.
However, the consequences of postponing maintenance can be harsh and will eventually lead to even more bottlenecks in your process down the road. When equipment breaks down and employees don’t have all the tools they need to perform their jobs effectively, you may have to deal with decreased output and lost revenue. According to research from Aberdeen, every hour of unplanned equipment downtime costs manufacturers $260,000 on average. With just a few adjustments to your maintenance scheduling process, these bottlenecks (and the high costs associated with them) can be avoided.
Survey the Plant
Before you can deduce the best process for your maintenance activities, we suggest getting started by compiling a detailed survey of every asset within your plant. This process will help ensure all the equipment used for production is accounted for. Once you have your full list, identify the maintenance actions needed for each individual item. If you need help determining the recommended frequency and time spent on maintenance for a particular part, be sure to consult the manufacturer’s instructions. With a complete catalog of tasks to work from, your maintenance team will then be able to anticipate all the plant’s upcoming needs. At the same time, your operations team can begin to reconcile their daily or weekly output with the corresponding maintenance requirements.
Prioritize Activities
After your survey of assets and related maintenance tasks is completed, your maintenance team can get to work planning a strategic approach. In every plant, some resources will be more integral than others, so it can be helpful to prioritize each asset based on how critical they are to the production process. The most vital equipment may be necessary for long periods during the production cycle, but it also must be well-maintained to function effectively. The maintenance for these high-priority assets will require more thoughtful planning. On the other hand, less-critical pieces of equipment can be arranged into the rest of the maintenance schedule as needed and won’t require as much detailed attention.
Create an Optimized Plan
With every maintenance activity prioritized, you can begin fitting each action into your ongoing production schedule. Aim to start by scheduling the highest-priority tasks first, and look for times when those pieces of equipment will not be in use to minimize the disruption to the plant’s workflow. If there will still be maintenance outages needed, plan for these in advance to give production planners time to prepare and work around them.
Taking these steps toward a more optimized maintenance schedule is a huge improvement over continual outages for reactive maintenance. It may seem counterintuitive to plan downtime when equipment isn’t technically broken, but when you can’t anticipate which pieces of equipment will be down and when, it often causes substantial waste and more missed opportunities for revenue.
It’s also especially helpful to schedule maintenance using an advanced planning and scheduling tool, such as VirtECS. This tool allows you to plug different blocks of time for maintenance into your schedule and see how it will affect your total output in real time. VirtECS completes all these calculations to find the most optimal schedule in just minutes. VirtECS can also communicate the finalized schedule to every employee who needs it, from maintenance experts to engineers on the plant floor, to keep processes flowing smoothly. Find out more benefits of implementing VirtECS at your plant here.
by Kelsey H | Feb 16, 2021 | Debottlenecking
Those who work in manufacturing know that getting a product from the beginning to the end of production is an incredibly complex and time-consuming procedure. The whole process is made more complicated by factors such as equipment designs, industry regulations, and employee schedules.
However, your plant’s constraints don’t have to be limitations on production. Instead, view them as pieces to the puzzle of your production schedule. While every business is unique, there are a few common constraints we help our clients solve. Keep reading to discover the issues caused by each of these constraints and how we recommend solving for them.
Purchase Material Availability
At your manufacturing plant, I’m sure you can identify a few crucial raw products that are essential to production. When there are inevitable disruptions to the supply chain, or if your inventory storage capacity is limited, you might find yourself short on these necessary materials. Delaying the start of a production run does not bode well for on-time deliveries, and ultimately, customer satisfaction.
In order to stay on top of supply chain delays and keep accurate material records, consider using inventory management software. This tool provides a platform for employees to update inventory records and track the current supply and demand of different materials in one place. Pairing this software with regular inventory inspections can help your organization better plan around potential shortages or delays. You can sidestep avoidable surprises, errors and wasted time.
Cleaning Between Tasks
Regular machine maintenance is crucial to help prevent sudden breakdowns and costly downtime at your facility. A number of industries, particularly those that work with pharmaceuticals or medical equipment, also require a strict cleaning regimen between production runs. If these regulations are not performed at optimal times, the cleaning can cause delays and eat up valuable production time. It may be easy to chalk these delays up as unavoidable, but the truth is, cleaning can be organized into your production plan with little to no disruption.
If you want to limit the cleaning process’s interference with regular manufacturing activities, we recommend scheduling maintenance as you would any other production process. This will give you time to analyze your production schedule and find opportunities to fit in maintenance without limiting the rest of production.
Specialized Labor
Throughout the production process, there will be certain tasks and responsibilities that only employees with specific training or experience can complete. Meanwhile, you may also have processes that run most efficiently when multiple employees are working on it at the same time. If your schedule does not account for these specifications, you risk developing a bottleneck and extending run times.
One potential solution is the implementation of a resource allocation tool. This kind of software can help quickly identify a number of workable schedule options that specify the optimal distribution of employees across the plant floor. Resource allocation software can also help determine if potential investments in labor, such as hiring additional employees, will generate a positive return. With this scheduling data, you’ll know that your plant floor is as well distributed as possible.
Equipment Allocation
Combatting extended periods of downtime between processes is an ongoing challenge on the plant floor. Even if things seem to be running smoothly on the surface, there may be hidden bottlenecks that are hindering your production efficiency. These constraints are driving up costs and decreasing your plant’s overall possible output.
In order to improve your plant’s run rate, you must identify all possible bottlenecks and potential efficiency improvements in your system. The easiest way to do this is with scheduling software, which can analyze your entire process to find the points of congestion. These features can help you decrease downtime and find unique production scheduling solutions to problems you may not have known you had.
VirtECS is an advanced planning and scheduling tool that has been designed to specifically solve these kinds of manufacturing constraints, along with many others. VirtECS is able to fully enforce all cross-area constraints and combine with other necessary tools to fully customize the handling of product-to-product timing and changeovers. As a result, VirtECS produces only feasible and executable production schedules that fit your plant’s specific needs. If you’re interested in learning more about how VirtECS can increase efficiency at your plant, download our guide here.
