How viable is the concept of continuous processing in a bioprocessing environment? The notion that batch is the only option is being challenged. Researchers believe that this is the next big step and they are proving this in the laboratory. One of the challenges left is implementing this method in the production environment on an automation system that is safe, efficacious, and satisfies the regulatory requirements.Is it possible to achieve these results with current automation strategies and products? The answer is a resounding YES. It is not only possible but there is already a model for this that works.
Let's start with some definitions so that we have a basis for this discussion. There are two basic methods of production: continuous and batch. Continuous processing is the continuous flow of material through one or more pieces of processing equipment, that when a steady state is achieved, a consistent product is produced for so long as the operation runs. Some processes are inherently continuous; steam production is a classic example. Batch processing is the flow of a finite amount of material through one or more pieces of processing equipment, that when a steady state is achieved, a consistent product is produced until the material is exhausted and processing is complete. A simple example of batch production is making cookies. Why is this important? These methods are nearly indistinguishable; the differences are how much material they are fed and how long they run.
How does this apply to automation in continuous bioprocessing? Automation of continuous and batch processes has been in existence for decades, where automation is defined as some combination of sensors, devices, instruments, controllers, operator interfaces, networks, computers, software, and logic that work together to drive, monitor, and control systems. Regardless of the industry or application, the same combinations and principles are applied. These apply to continuous bioprocessing as well. These projects can be executed with the same tools, in the same way and with the same successful results. There are some considerations when executing any project, and these apply to continuous bioprocessing as well. The first consideration is the KISS philosophy: Keep It Short and Simple. This is especially important in applications in regulated industries where everything that is implemented in an automation system must be validated. What is nice to have or fancy is not necessarily what you need. Second, use guidelines such as Gamp5 (good automated manufacturing practices) and ISA-88 (batch control standard), in addition to your company's policies and procedures, to have a methodical approach to execution. Third, and most important, is YOU; apply your knowledge of the industry, process, your company's policies and procedures, and regulatory guidelines, throughout the life-cycle of the project. Make decisions early to reduce the necessity for changes later in the project; small changes along the way can have a negative impact on your budget and schedule.
Regardless of the process, industry or regulatory requirements, automation can be easy. Automation systems must be designed and built to function correctly, report information accurately, be safe, have longevity, and satisfy regulatory requirements. They must also be robust to maximize profit while reducing the risk to personnel, equipment, and product. By making decisions early, documenting your design in a logical and concise manner while utilizing existing standards, and being present during all stages of the project, you are an integral part of its' success. The good news is that there are automation systems that will support your process, company, and current regulatory requirements.
Give us a call to discuss our expertise in implementing automation systems from specification through verification.
Why do so many Electronic Batch Record (EBR) initiatives fail to deliver value? The answer is usually simple; the results that would be deemed valuable were never defined up front. Most EBR initiatives start off with the goal of getting rid of the paper batch record and then end with the stakeholder saying, "Great, now how did this help us again?" If the truthful goal is simply to "go electronic" very little value will be realized from an EBR effort, with the exception of pure regulatory compliance. So how do you avoid this pitfall in your EBR initiatives? Define the aspects up front that add value, work toward those, and let those aspects drive the EBR architecture and infrastructure.
Is part of the EBR initiative to streamline production?
If so, then a simple conversion of the paper batch record to an electronic system will not do the trick. In fact, in most cases, cycle times will initially go up after the transition. Streamlining your production often means that your EBR system will end up incorporating many MES type functions for equipment and usage scheduling before cycle times are reduced.
Is "Right the First Time" part of the EBR initiative?
If this is your goal, then the EBR system will need to be integrated with systems that can provide critical data points to the production process (scale weights, room conditions, etc). The EBR system should also be performing calculations that were previously done manually to guarantee accuracy. Your EBR system may end up looking more like a "workflow" application, one that is very prescriptive with work instructions.
Is a streamlined quality review part of the EBR initiative?
Batch reports are often flooded with data that may or may not impact product quality. Exception based reporting is the answer. Quality must trust that the EBR system properly indicates when a deviation from the normal process occurs or when parameters drift out of specification. This can help reduce the review process dramatically.
These are only a few of the aspects that must be considered during the system development process to allow you to extract the full value out of the final EBR system. Let us help you explore these and other key factors of your EBR initiative to help gain the most value from the final implementation.
During a project for a pulp and paper mill client, we were tasked with optimizing the water usage on a wash line. This entails feeding material into the wash line and spraying it with water to wash out undesired materials to promote a uniform consistency. There are a number of measurements used throughout the line to monitor key variables to identify the "quality of wash", etc. This process requires a complex control scheme.
This particular control scheme attempted to automate many of the things an Operator might do to actively manage the system in question. Still, there remained as always, factors outside of the control system's visibility. For such items, an effective interface for the Operator or Engineer to enter these factors into the system is required. This may be as simple as high and low limits, or as complex as the maximum rate of change for the trim ratio of a cascade loop. Our job as the enabling engineer is to design a way to present this data concisely and accurately as an integral part of the control scheme.
Take for example the following data entry section:
The basic design was made to allow the Operator the ability to check the enable box to turn the Dilution factor On or Off. Then, the Operator has two spots (the yellow numbers) where desired set points could be entered. In addition, the current mode of the controller is shown in a compact form. (For this screenshot we are in manual.) Finally, a few additional values were calculated and displayed in grey to indicate the Operator cannot enter any data.
There are a few key takeaways to point out.
At the end of the day, you need to keep two guiding principles in mind when it comes to HMI design. First, the Operator has enough on their plate already. Adding complexity and distraction with your HMI just makes things worse. Second, and most important, the Operator is the primary customer. With that in mind, do not design an interface only an engineer could love. If you will keep these goals at the forefront of your project when designing the HMI's you will end up with a happy customer... your Operator.