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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.