Why Automation is Foundational to the Maturing of the Cannabis Essential Oil Industry
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A standalone fully automated Supercritical CO2 Extraction System. Photo Courtesy of Apeks Supercritical by Gibraltar.
Automation applies to nearly every aspect of modern life from automobile manufacture to pharmaceutical production and from high throughput laboratory screening to package delivery. The cannabidiol (CBD) essential oil industry, both production and laboratory, is no exception. Automation will become an ever-increasingly important means of achieving efficient high volume, high quality production whilst assuring purity and potency compliance to government regulations.
Automated CBD extraction processing ensures that every batch is within specification. And this is exactly what government regulators require: consistency, repeatability, quality, and pure, unadulterated product. Regardless of the fragmented state of national and international regulations, or lack thereof today, everyone in the industry recognizes that in the future regulation will be similar to current good manufacturing practices (cGMPs) found in the pharmaceutical and food industries. Consistent performance will be essential for the maturing of the cannabis industry.
Jeremy Sexton, director of engineering for processing solutions by Gibraltar, which includes Apeks Supercritical and Delta Separations, leaders in both carbon dioxide and ethanol-based extraction systems respectively, offered these thoughts on cGMPs and automation equipment.
“Not only must the process conform to cGMPs, it is equally important that the components carrying out the process meet exceptional standards,” he said. “Building a machine that lives in a cGMP environment requires the original equipment manufacturer (OEM) to use specific types of wetted components and be able to trace those components with documentation to verify what has been used
Automating the extraction process not only makes compliance to cGMPs expected by the FDA of mature industries easier, but also maximizes essential oil output at minimum labor cost. Automated processes lead to low waste and contribute to a favorable bottom line.
Sexton added an important note on other implications of having an automated system. “Automation and data collection involve utilizing Title 21 of the Code of Federal Regulations (21CFR11) as a guide for electronic record keeping and electronic signatures,” he said. “It’s been our experience that facilities that have an International Standards Organization (ISO) 9001 program are typically in an excellent position to implement and follow the guidelines for the extensive amount of documentation required, including documentation on system calibration.”
21st century automation’s application to the oil extraction process
Regardless of whether CBD oil is extracted via supercritical CO2, ethanol, or steam distillation, chemical processing is involved. Each of these modes of extraction has a unique “recipe” where fluids are pumped at specific flows and pressures, ingredients added, and mixtures heated, chilled, distilled, or pressurized.
A complete automated processing system can be delivered fully assembled and ready for production. These units are called skids. A skid can be used for part of a process or all of it, depending on its design. Skids can be standardized off-the-shelf products or customized. Typically, skids are used for low to moderate levels of production. For large scale production, automated systems are assembled on site and are only limited in terms of output by budget and available floor space.
Whether a facility uses a skid or a large-scale production system, process automation can be analyzed by major system/component types. For example, fluid flow is regulated by automated valves – ball, butterfly, and solenoid. Pumps, motors, and compressed air move fluids, ingredients, and actuators. There are components to heat, chill, and pressurize. Analog and digital sensors measure pressure, flow, temperature, and position. A new generation of smart sensors can also predict component failure and give the operation time for a planned versus unplanned shutdown. Human-machine interfaces (HMI) – monitors or industrial computers – provide a window into the process. From the HMI operators can, for example, monitor the status of the process, view the condition of components such as pumps, access a runtime data log on crucial processes, and find information on system maintenance, and/or operate the system as a manual operation.
Automated systems can be programmed to produce multiple products similar to a brewery where a single brewhouse can be used to turn out different styles of beer. As long as the basic process is the same, automated essential oil systems can produce a range of products.
The brain of the automated process control system is typically a programmable logic controller (PLC), which is a specialized computer first developed in the 1960s for the automotive industry. The PLC sends signals to the valves, pumps, and motors to open and close and to turn on and off. The PLC monitors conditions based on sensor data and alerts operators through the HMI to fault conditions. Specialized PLCs control both electric and pneumatic systems from a unified control architecture. Through an Internet Gateway, the system can be accessed by authorized personnel located remotely.
In a PLC-based system the recipe is carried out with 5-to-10 millisecond accuracy in terms of controlling heat, pressure, and flow. This is the level of repeatable process control that cGMPs require. An operator with a clipboard opening a valve at a specific time or turning off a motor following a set duration cannot approach the precision of automated process control batch after batch and day after day. This is why the cannabis industry is moving toward automation – a mature regulated industry requires consistency and must have the process records to prove it. Automated systems not only control the process, but also provide validation documentation in conformance to 21CFR11 guidelines.
Automation does not stop with essential oil extraction
It can be useful to think of automated systems as a series of integrated modules, all of which are designed to boost throughput and quality while lowering waste and labor. The beginning module is oil extraction. The output of that extraction process is automatically pumped into an interconnected module for filling and capping jars of tinctures and/or lotions. Via conveyor, the next modules in line are labeling, packing in cartons, case packing, and palletizing. Data collection provides track-and-trace information. Modules can be added at any time as needs arise. And all these automated modules can be linked into an end-to-end process so that as volume grows, automated solutions are there to support increased production.
The importance of GAMP 5 to the cannabis industry
Government regulators demand consistency and the public expects it. The question becomes: How does an automated system supplier – a skid manufacturer or a design/build engineering company, for example – ensure that the automated system is actually producing an end product that will meet specifications? An automated process does not ensure the required final product result. The answer is that the automated system must be validated to ensure its conformance to specifications.
These same questions about validation were asked by the pharmaceutical and food industries decades ago when computerized controls were first used. A consensus was reached in the early 1990s with the formation of a group in the United Kingdom dedicated to developing Good Automated Manufacturing Practices (GAMP). GAMP provides guidelines for ensuring automated systems comply with U.S. Food and Drug Administration (USDA) expectations for cGMP. The first GAMP document was published in 1994. GAMP 5, issued in 2008, deals with developing control systems that lower the risk of variation. Today, GAMP is a technical subcommittee of the International Society for Pharmaceutical Engineers. GAMP 5 has become the de facto methodology for validation in the pharmaceutical industry and other businesses where the health and safety of the public is a primary concern and processes are computer-controlled.
GAMP documentation is an extensive process and requires technical expertise. The strenuous GAMP process is valuable because it documents at a world-class level that this extraction control system conforms to global good practices. Once the system is in operation at the customer site, GAMP processes and procedures must be followed in terms of training, operation, maintenance, and change management. Following GAMP 5 helps to ensure that practices comply with FDA or other government requirements. Manual control with written records simply cannot compare.
Lab automation has different automation requirements but the same compliance goals
Laboratories are vital to the cannabis industry both for new product development and product testing. Utilizing more automated lab processes lowers the opportunity for human error. While the pumps, valves, motors, vessels, and sensors used in lab equipment are smaller than in a production setting, the principles of control remain the same. In addition, lab equipment has the need for microliter-level control of fluids, a level of precision not required in the extraction process. There is also the mechanical need in automated lab equipment to control the motion of pipettes, microplates, vials, and caps. Printers and track-and-trace systems such as barcode readers and vision sensors are also within the control system’s purview. Accuracy and repeatability in the lab are essential, and automated laboratory devices are built and validated to exacting standards. Validated equipment, like equipment in the production room, must undergo instrument, operational, and performance qualification; preventative maintenance; and re-qualification after servicing. In addition to lab equipment, top testing laboratories adhere to Good Laboratory Practices (GLP), and many earn ISO 17025 accreditation for their processes.
Technical support for automated systems
One of the key factors to evaluate when buying an automated system or piece of laboratory equipment for high volume oil extraction or high-volume laboratory testing is the availability of replacement parts. Proprietary/custom spare parts indicate long wait times for replacements. It is also a good idea to work with an OEM that builds extraction systems from the ground up and does not outsource subsystems such as control panels to a panel shop. Ground-up manufacturer's technical support personnel typically have faster response times and a complete knowledge of hardware, software, and conformance to guidelines that leads to optimum issue resolution.
No one expects a lab technician or cannabis business owner to be an expert in automation or equipment and process validation. What is beneficial, and increasingly important, is that key personnel have a general understanding of the terms and the issues involved in process and laboratory automation. A level of understanding sufficient to inquire about and assess key areas is vital to growth, competitiveness, and compliance.
The author of this article, Mike Severino, welcomes your comments: firstname.lastname@example.org