Why automation is the foundation for a mature cannabis oil industry
From automotive manufacturing to pharmaceutical production, and from high-throughput lab screening to package delivery, automation applies to nearly every aspect of modern life. The cannabidiol (CBD) essential oil industry, both in production and in the lab, is no exception. Automation will become an increasingly important means of achieving efficient high-volume, high-quality production while ensuring purity and efficacy in compliance with government regulations.

Automated CBD extraction processing ensures that each batch is within specification. This is exactly what government regulators require: consistency, reproducibility, quality and a pure, uncontaminated product. Regardless of the fragmented state of national and international regulations, or the lack of regulations today, everyone in the industry recognizes that future regulations will be similar to current Good Manufacturing Practices (cGMP) in the pharmaceutical and food industries. Consistent performance is essential to the maturation of the cannabis industry.

Jeremy Sexton, director of engineering for processing solutions in Gibraltar, presented Apeks Supercritical and Delta Separations, leaders in CO2 and ethanol-based extraction systems, respectively, with ideas about cGMP and automated equipment.

"It is equally important that the process not only meet cGMP requirements, but that the components performing the process meet specific standards," he said. "To build machines that can be used in a cGMP environment, original equipment manufacturers (OEMs) must use specific types of wetted components and be able to track those components using documentation to validate the components that have been used

Automating the extraction process not only makes it easier for mature industries with FDA expectations to meet cGMP requirements, but also maximizes essential oil production with minimal labor costs. Automating the process reduces waste and contributes to increased profits.

Sexton adds an important note about the other implications of using an automated system. "Automation and data collection involves utilizing Title 21 of the federal regulations (21CFR11) as a guide for electronic records and electronic signatures," he says. "In our experience, plants with International Standards Organization (ISO) 9001 programs are typically in a superior position to implement and follow guidelines regarding extensive documentation, including system calibration documentation."

21st Century Automation in the Oil Recovery Process

Whether CBD oil is extracted by supercritical CO2, ethanol or steam distillation, chemical processing is involved. Each of these extraction methods has a unique "recipe" in which fluids are pumped at a specific flow rate and pressure, components are added, and the mixture is heated, cooled, distilled or pressurized.

The complete automated processing system can be fully assembled and delivered for production. These units are called skids. Skids can be used for part or all of a process, depending on their design. Skids can be standardized off-the-shelf products or can be customized. Typically, skids are used for low to medium level production. For large scale production, the automation system is assembled on site and is limited only by budget and available floor space.

 

Operation overview screen on the HMI of the extraction system. Photo courtesy of Festo.

Whether the plant uses a skid-mounted system or a mass-production system, process automation can be analyzed by the main system/component types. For example, fluid flow is regulated by automatic valves (ball valves, butterfly valves and solenoid valves). Pumps, motors and compressed air move fluids, dosing and actuators. Components with heating, cooling and pressurization. Analog and digital sensors measure pressure, flow, temperature and position. New generation smart sensors also predict component failures and give run times for planned downtime versus unplanned downtime. The human machine interface (HMI) - a monitor or industrial computer - provides a window into the process. For example, from the HMI operators can monitor process status, view the condition of components such as pumps, access run-time data logs of critical processes, and
The automation system can be programmed to produce a variety of products similar to a brewery, where a single brewery can be used to produce a different style of beer. An automated essential oil system can produce a range of products as long as the basic processes are the same.

The brain of an automated process control system is usually a programmable logic controller (PLC), a dedicated computer first developed for the automotive industry in the 1960s. the PLC sends signals to valves, pumps and motors to turn on and off and to turn on and off. the PLC monitors status based on sensor data and warns the operator of fault conditions via an HMI. Dedicated PLCs control electrical and pneumatic systems from a unified control architecture. The system can be accessed by authorized personnel at a remote location through an Internet gateway.

In a PLC-based system, the recipe is accurate to 5 to 10 milliseconds in terms of controlling heat, pressure and flow. This is the level of repeatable process control required by cGMP. Operators with clipboards that open valves at specific times or turn off motors after a set duration cannot achieve the accuracy of automated process control batch after batch and day after day. That's why the cannabis industry is moving toward automation - a mature regulated industry needs consistency and must have the process records to prove it. Automated systems not only control the process, but also provide validated documentation of compliance with 21CFR11 guidelines.

Essential oil extraction is more than automation

It can be useful to think of an automated system as a series of integrated modules, all designed to improve throughput and quality while reducing waste and labor. The starting module is oil extraction. The output of this extraction process is automatically pumped to an interconnected module to fill and cap the tin agent and/or emulsion. Via a conveyor, the next module in the line is labeling, carton packing, case packing and palletizing. Data collection provides tracking information. Modules can be added at any time as needed. And all of these automation modules can be linked to the end-to-end process so that as production grows, the automation solution can support the increased throughput.

The importance of GAMP 5 to the cannabis industry

Government regulators demand consistency, and the public expects it. The question then becomes: how can an automated system provider (e.g., a skid manufacturer or design/architectural engineering firm) ensure that the automated system actually produces a final product that meets specifications? The automated process cannot ensure the desired end-product outcome. The answer is that the automated system must be validated to ensure that it meets specifications.

Decades ago, when computer control was first used, the pharmaceutical and food industries raised the same questions about validation. In the early 1990s, a consensus was reached when a group was formed in the UK to work on the development of Good Automated Manufacturing Practices (GAMP).GAMP provides guidelines to ensure that automated systems meet the US Food and Drug Administration's (USDA) expectations for cGMP.The first GAMP document was released in 1994.GAMP5 was released in 2008 and is dedicated to developing control systems that reduce the risk of variation. Today, GAMP is a technical subcommittee of the International Society of Pharmaceutical Engineers.

GAMP documentation is an extensive process that requires specialized technical expertise. The painstaking GAMP process is valuable because it demonstrates at a world class level that the extraction control system conforms to global good practice. Once the system is operational at the customer site, it is essential that GAMP processes and protocols are followed for training, operation, maintenance and change management. Compliance with GAMP 5 helps ensure that practices are in compliance with FDA or other government requirements. Manual controls with written records simply cannot be compared.

Laboratory automation has different automation requirements, but the compliance goals are the same

For new product development and product testing, laboratories are critical to the cannabis industry. Utilizing more automated lab processes can reduce the potential for human error. While the pumps, valves, motors, containers and sensors used in lab equipment are smaller than those used in a production environment, the control principles remain the same. In addition, laboratory equipment requires microscale control of liquids, which is not required to achieve a certain level of precision in the extraction process. In automated laboratory equipment, machinery is also needed to control the movement of pipettes, microplates, vials and caps. Printers and tracking systems (such as barcode readers and vision sensors) are also within the scope of the control system. Accuracy and reproducibility in the laboratory are critical, and automated laboratory equipment is manufactured and validated according to strict standards. Verified equipment, such as that in the production room, must be certified for instrumentation, operation and performance; preventative maintenance; and requalification after repair. In addition to laboratory equipment, top test labs follow Good Laboratory Practices (GLP), and many are ISO 17025 certified for their processes.

Technical support for automated systems

One of the key factors to evaluate when purchasing automated systems or laboratory equipment for high-volume oil recovery or high-volume laboratory testing is the availability of spare parts. Proprietary/custom spare parts indicate long waiting times for replacement. It is also a good idea to work with an OEM that will build the extraction system from scratch and will not outsource subsystems (such as control panels) to a panel shop. A solid manufacturer's technical support staff usually has faster response times and a thorough knowledge of hardware, software, and meets the guidelines that will best solve the problem.

 

 

On-site service support - start-up and commissioning. Photo courtesy of Gibraltar Apeks Supercritical.

No one expects a lab technician or cannabis business owner to be an expert in automation or equipment and process validation. It is useful and increasingly important that key personnel have a general understanding of the terminology and issues involved in process and laboratory automation. A level of understanding sufficient to query and assess key areas is critical to growth, competitiveness and compliance.

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