Psychedelic Trip: Let there be Data

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As the world turns an eye to therapeutic alternatives and the reform surrounding them, there's a topic that keeps capturing headlines - psychedelics. While still grouped as an illicit drug by today's standards, psychedelics are slowly, and discretely making their way to research facilities near and far. The mindset is this: If Cannabis can do it, so can psilocybin. But if the diligent systems and bureaucratic intricacies that once surrounded cannabis legalisation (and in some cases depending on geography still do) should serve as an indication: a fledgeling future for medicinal psychedelics will weigh heavily on precise data, process, and compliance.

 

Overcoming a Century-Old Stigma 

Changing the public perception of something embedded with stigmas is no easy feat. Since the Opium Act of 1908, governments around the world have worked to protect citizens from what they categorised as illegal substances. Such was the case with Cannabis when it joined the restricted list in 1923. 

Through legislative processes grounded in research and data, we've seen global strides taken in the face of changing public and government opinion. Efforts by countries, especially Canada, that have led the way in setting a progressive precedent for other nations to follow, and a blueprint for future industries to reference when faced with similar hurdles along the way. Nationwide Cannabis legalisation in 2018 in Canada, opened the doors to better study and understand the benefits of the plant, the seemingly endless types of cannabinoids and how to extract them, isolate them, and utilise them for different applications. In the lead-up to and amid Legalisation 2.0 extraction played a leading role not only in delivering a quality product for Licensed Producers but set a precedent in areas of controlled research. And while it may not have been high on the initial list of reasons, after years of in-depth study on Cannabis has indirectly given the approval of and confidence for emerging industries like medicinal psychedelics to follow. 

 

It's Not about the Trip; It's about the Journey

The success story that Cannabis is basking in today didn't come without obstacles. Remember the restricted list of 1923? Cannabis sat on it for decades, as the government largely overlooked decriminalisation and regulation - and how to merge the two. Positive as the shift was when they approved the production and distribution of medical Cannabis in 2013, it brought to light the grey areas behind the term 'legal'.  

The research of micro-dosing of psilocybin, the primary psychoactive ingredient in mushrooms, and slated to be the next major breakthrough in healthcare, is facing similar obstacles surrounding the contradictory legalities that its predecessor once endured. At present, psilocybin is still considered a drug, illegal on many lists and making research efforts to study the potential benefits, and the restrictions controlling the 'how' an uphill battle. 

Initial efforts have once again raised awareness to the same vital points flagged when Cannabis came into question on the road to legitimacy - compliance, safety, and good manufacturing practices. It has also brought to the forefront those entities and bodies who will once again play a supporting role in enhancing programs behind the research and development of the world's next therapeutic alternative. 

Institutions that have been granted a head start in exploring the ins and outs of the plant are highlighting areas that need more in-depth consideration. Safe manufacturing practices and the right systems required to gather data on the complexities of specific molecules and compounds are cited as the more complicated areas, among others. The University of Toronto recently launched the Psychedelic Studies Research Program (PSRP), dependent on Health Canada's approval of both the clinical trials and manufacturing process. PSRP has cited that without quality standards in place and the regulation that outlines the standards, it is impossible to manage the output of substances that are needed for controlled research. To reach that vital point of discovery will mean putting trust in science and a system with measures in place to support the regulation of those findings.

Have a product you want to be extracted for research purposes? To learn more about our research and development programmes, reach out today.

Keeping it Real: Edibles, Concentrates, and Topicals

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Has it been a year already? Marking the anniversary since the legalization of cannabis in Canada brings with it an even more exciting milestone for the market - the addition of edibles, concentrates, and topicals. It's a promising step for the industry at large in encouraging healthy competition. More importantly, it shines a light on the behind-the-scenes work to ensure safe practices and responsible processing for every product bound for the market.   

Legalization 2.0

Reaching this point in the journey of legalization certainly didn't happen overnight. It's a significant shift in both policy and mindset that hasn't happened since the end of alcohol prohibition. In fact, this recent news has been in the works for years, just not out in the open. A task force comprised of consultants, federal bodies, and industry experts have been leading studies and gathering facts to develop the framework for what's been coined 'Legalization 2.0'. 

What took so long exactly? Most of those closed-door conversations centered around establishing what safe consumption limits looked like, which standard packaging rules to apply, and how to enforce specific marketing standards. As straight forward as those measures may seem to anxious consumers, it's a learning curve that will take some time for even for the most prepared in the industry to get right, and a valid reason behind the uncertainty on how soon products will hit stores. In line with Health Canada’s mandatory 60-day notice period for companies to submit documented proof of compliance, it's assumed the mass availability of such products won’t happen before January of 2020. 

For more information on Canadian Regulations, visit the Government of Canada website

A Battle with the Black Market

While a progressive move, Canada's strict regulations on cannabis are set to ensure the health and safety of the public, with ambitions to displace the industry’s black market. Global research consultancy firm Deloitte estimates that the second wave of cannabis legalization is expected to open a $2.7 billion market in Canada, with cannabis-extract-based products accounting for about $1.6 billion. Figures like these pose a question of how the 'bad guys' fit into that future equation. Recent scandals of THC-vaping products suggested to be tied to illegal vendors have created an air of caution with consumers and opened the gates of opportunity for those able to answer the demand with safe, consistent, and affordable product lines. As the legal industry matures and responds to the factors that have kept the illegal side booming -- which include cost, location, and supply -- it’s bound to cut deep with the black market.

From gummies and creams, cookies, and shatter, keeping these edibles, concentrates, and topicals pure doesn't start in the storefront, rather begins in the stage of turning flower into extracted oils. When it comes to extracting with the cleanest process and producing a pure broad-spectrum output, CO₂ remains the reigning champ. Unlike butane and ethanol methods that are toxic and flammable, CO₂ extraction uses temperature and pressure to produce a clean, quality pull of essential compounds. No harsh residual chemicals or contamination of harmful toxins within the final product - be it concentrates, topicals and edibles - means you can count on it being 100% pure cannabis, and 100% safe.

Learn more about the pure process of CO₂ extraction in our Guided Tour

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Top 3 Skills to Look for in an Operator

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The success of the most sophisticated systems in the world, from planes and trains, to computers, and medicine are all dependent on one thing - their operators. A testament that no matter how complex a design or automated a process might be, there still needs to be an expert in control. Extraction is no different. In fact, the reliability of your investment depends on the men and women balancing variables, comparing numbers, and using their intuition to reach an optimal output. How do you find the top talent to run the most critical part of your business? We’ve got you covered with the top three essential skills to look for in an extraction Operator. 

1. MECHANICAL APTITUDE

An Operator wears many hats when it comes to CO2 extraction, from handling biomass, and monitoring the flow of solvent to adjusting the pressure and conducting preventative maintenance tests. Talk about a long list of duties, which is simpler for those who come from industries that require the same knowledge, such as mining, oil and gas, heavy equipment operations, and other processing machinery. What exactly does experience on a rig have to do with operating an extraction machine? More than you think. Having a mechanical aptitude of any kind means being aware of the function of the component that makes up a complex system. 

Take the phase management aspect of CO2 extraction systems. It offers versatility and control of specific extraction parameters in the process, but with that comes a level of manual application - turning levers and setting pressure and temperature boundaries. It’s like hopping into a Ferrari. You better make sure you know what all the buttons do if you want to utilize the car’s full power potential and get the most out of the experience.

Coming from a similar industry and understanding the motions isn’t the only valuable takeaway. Previous experience also brings a familiarity with the technical terms of the job. To find someone who has not only mastered the craft but is fluent in the language around the process, equipment, and roles from day one, means saving valuable training time and resources.

2. CRITICAL THINKING 

As much as it is a science, let’s not forget that extraction is also an art. Sure the systems are meticulously designed and built to do the work, but some aspects require creativity. Operators are in a constant state of trying to strike the right balance with several variables - temperature, time, pressure, and more - all in an aim to find that extraction sweet spot. The pace of the industry is moving quickly, and with technical systems to match, having the ability to think critically has never been more precious to a company’s bottom line. 

Machines won’t always run the way intended, and troubleshooting won’t always be straightforward. Even having a system down for an hour is enough to cause a hard hit on profits. While Vitalis support will always be an option - we want to be our client’s last resort on account that an Operator was able to think on their toes and correct it themselves to ensure little to no downtime. A natural comparison is when a pilot receives an alert that there’s something wrong with the aircraft and has a very short window of time to fix it until things go downhill. Scrolling through a user manual would likely slow things down. So, what kind of pilot would you want in charge? If we had to take a guess, it would be someone with that natural ability to assess a situation, identify discrepancies, and create workable solutions to be communicated to an entire team. 

3. FOCUS

Optimizing throughput and efficiency when working long hours isn’t easy for everyone. Add to that having to follow a particular set of detailed instructions and record data means being alert and proactive as an Operator is a must.

It’s not just a skill we encourage our customers to seek when building their team. Being able to focus is a crucial aspect we look for in every one of our Vitalis Operators charged with performing our standard Factory Acceptance Tests before delivering the systems. Over an extended time, our team tests the equipment under minimum and maximum operating conditions for accuracy, safety, and consistency. We take it seriously, being one of the final people responsible for ensuring the systems are flawless.

SUPPORTING YOUR OPERATORS TO SUCCEED

Finding the right Operator with these three essential skills is one piece of the puzzle to extraction success. No matter who fills that role, it’s crucial they are fully equipped with the tools and the support they need to perform. Lending a hand to our customers and bridging that gap with training, manuals, and 24-hour assistance long after the systems are delivered to run their machines will always be a top priority. 

Want to learn more about setting your business up for success? Speak to one of our experts today. 

In Case You Missed It: GMP Basics

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Europe is the next big-ticket for medicinal cannabis, but it’ll take more than just having the right resources and team in place to make an entrance. The key to accessing this emerging market is having Good Manufacturing Practice (GMP) accreditation. A requirement that all medicinal products come from a GMP accredited manufacturer is one of many strict regulatory measures the European Union has put into place. Their aim is to assure both regulators and consumers that the products are safe, consistent, fit for purpose, and of the highest quality.

As part of our Vitalis educational series, our team of experts recently led a webinar on the process of obtaining a GMP certification for the equipment. In case you missed it, we’ve recapped the most important points to consider.

What is qualification versus validation?
Validation is an act, process, or instance to support or collaborate something on a sound authoritative basis. Qualification is an act or process to assure something complies with some condition, standard, or specific requirements.

Does the Factory Acceptance Test (FAT)  include actual extraction performance as performed on the customer like feedstock?
No. The FAT includes running the machine at a minimum and maximum operating parameters with no product. It allows for any issues with the machine to be identified in the absence of the product.

Are all of your gauges also field calibratable for future Performance Qualification?
Yes, all of the sensors and gauges can be calibrated by a qualified professional in the field.

Does re-using and recycling CO2 present any GMP challenges?
Re-using any solvent in a GMP environment does pose a challenge. You must prove that the recycled solvent will not affect the product quality of future batches.

Is there any statement in any of the GMP schemes that define Calibration requirements during the maintenance/life cycle of the equipment?
GMP regulations do not state how often instruments should be recalibrated as every instrument will be different. Manufacturers may provide a recalibration schedule, but it is ultimately up to the customer.

How does the development of Standard Operating Procedures (SOPs) fit into the GMP documentation sphere?
Any task that is done in a GMP environment that affects product quality should have a SOP to support that task. Having a SOP ensures that the task has been evaluated and is done the same way every time.

Does the scope of GMP change based on the stage of the process? For example, does a solvent tank require the same surface finish as an extractor?
They do not necessarily need to have the same surface finish. GMP is a risk-based system. If the risk of microbial or chemical contamination of the surface is high, then a smoother surface would be warranted to allow for easy cleaning. The solvent tank will probably only contain solvent and no product. Depending on the solvent, the surface finish may be rougher as the risk of microbial contamination is low.

Who is responsible for verifying and providing the GMP certification, and is it different per jurisdiction?
Every GMP jurisdiction will have a regulatory authority with inspectors to carry out audits.

Are EU-GMP regulations the most stringent?
It is hard to argue who has the most stringent GMP regulations, but the most highly regarded regulations can be found in the US (FDA), the EU, and Japan. Traditionally the FDA has been the largest pharmaceutical manufacturers while the EU and Japan are the largest markets, both bringing with them their own set of mature regulations.

What insight do you have into the qualification process for multiple pieces of equipment from different manufacturers?
Each piece of equipment in a GMP environment needs to be qualified separately, regardless if they are from the same manufacturer or not. When using multiple manufacturers, the qualification effort may be more as each manufacturer may offer differing levels of support and documentation. If you can procure equipment from the same manufacturer, then you only have to deal with one company, which may streamline your overall GMP validation efforts.

Is EU-GMP easier or more cost-effective for CO2 extraction technologies versus ethanol extraction?
Both can be used for GMP purposes. However, it all depends on the products you are manufacturing, as well as the pre- and post-processing methods required. There are additional infrastructure requirements when using ethanol and getting ethanol of the required grade may be difficult depending on geography.

Are cannabis extractors currently required to be GMP certified in Canada?
Cannabis extractors do not need to be GMP certified in Canada; they must adhere to Good Production Practices (GPP).

Is it possible to operate a GMP certified piece of equipment in a non-GMP certified facility? i.e. can you get a qualification on the machinery, but not the whole facility?
GMP certification applies to the entire production process, so you can’t have GMP certified equipment in a Non-GMP facility. You can have equipment that is GMP compliant and that receives the qualification in a non-GMP facility.

Is it possible to have a fully compliant lab and make dangerous products?
Many common pharmaceutical drugs and foods such as coffee, if consumed in excess, can be toxic and, therefore, dangerous. Most pharmaceutical drugs, if not taken as per the manufacturer's recommendations, can have harmful effects on an individual. Every pharmaceutical drug has to go through an approval process, and part of that is determining the safe dosage. If the advice is not followed, then there could be harm to the consumer, but if the advice is followed, there should be no issues, and the drug can be considered safe.

What if your terpenes are made in a Current Good Manufacturing Practice (cGMP) facility, but you add too much to a cartridge and vape at too high of a temperature?
Take, for example, if terpenes are made in a cGMP facility, but too much was added to the cartridge and vape at too high of a temperature. This has been occurring in the USA due to very lax regulation at the state level on vape cartridges and no regulation at the federal level. Equally, it means the FDA, the agency tasked with protecting consumer safety, cannot. The only way to avoid such a thing is for cannabis to be brought within the scope of the FDA where they can regulate the vape cartridge contents and set limits.

cGMP is one part of consumer safety, but does that mean it is necessarily assurance of its safety?
GMP is meant to protect consumer safety during the manufacturing process of the product. GMP has nothing to do with whether the product itself is safe. Product safety is covered when a pharmaceutical drug is submitted to the FDA for approval and is what clinical trials establish. GMP will guarantee that the product has been manufactured consistently and to the highest possible standards.

Interested in learning more about GMP? Speak to one of our experts today

Take a Guided Tour of CO2 Extraction: Part 1

From the machinery and components through to solvent recovery, learn how CO2 extraction is made possible!

Part 1 - get familiar with the systems and equipment involved, from pump technology to phase management.

Carbon dioxide (CO2) makes an excellent extraction solvent for botanical oils. CO2 is a unique solvent as it retains its solvency power as either a (subcritical) liquid or as a supercritical fluid depending on the respective temperature and pressure. By changing the pressure and temperature of CO2, its solubility and selectivity for a specific compound of interest can be changed to optimize an extraction.

This three-part series will provide a guided tour through the process of extraction using CO2 as the extraction solvent. Various aspects of the extraction system will be covered ranging from the machinery and components, the different parameters that can be used, to the interwoven principles of extraction (see Figure 1 for an overview). The first part will provide a mechanical focus on the early stages of the process, particularly on storage of the solvent and the distribution of the solvent via a dual acting positive displacement pump. Part two will examine what occurs during the extraction process in the extraction chamber, solvent power and the associated solubility. Finally, part three will cover the separation of the solutes from the solvent stream and solvent recovery.

The Vitalis Difference - Figure 1 Pages - Block Diagram-01

1. STORAGE

The extraction process begins with the CO2 accumulator. This is the reservoir that supplies the system with solvent during operation. CO2 can be stored here as either a low-pressure gas, a high-pressure gas or a liquid.

The Vitalis Difference - Phase Management - Final_corrected

2. DISTRIBUTION

The pump is the next stage of the process. The job of the pump is to deliver CO2 to the system at a selected pressure. The two most common pumps that are used in the extraction industry today are dual acting positive displacement pumps and diaphragm pumps.

DUAL ACTING POSITIVE ACTING DISPLACEMENT PUMPS

Dual acting positive displacement pumps have the ability to deliver an uninterrupted flow of solvent into the extraction system. In turn, the pump’s hydraulic cylinder applies force to two oppositely directed pistons. Liquid enters the available space ahead of one piston, as force is applied to the other to deliver a volume of the solvent. At the completion of this stroke, force is then applied to the opposite piston, now primed with a volume of solvent ready for delivery to the next section of the machine. Hence, dual acting positive displacement pumps eliminate the interruption in solvent output (by eliminating the down stroke). Figure 2 shows the recharge and output operation of the dual acting positive displacement pump. Due to their efficiency and continuous solvent delivery, and the fact that their design is very robust, they are the favored option for use in extraction equipment.

Figure 2

DIAPHRAGM PUMPS

Briefly, solvent only enters diaphragm pumps on their down stroke and is then delivered on their output stroke (Figure 3). Despite numerous variations on their designs, solvent delivery results from these pulses; thus, the system will experience an interruption in the flow of solvent at each down stroke as the pump is primed with a new volume of solvent for delivery. Furthermore, diaphragm pumps generally have smaller displacements (being that the pump strokes provide a lesser fluctuation in internal volume) and operate at higher frequencies (more cycles for the life of the operation) which results in increased wear and system pulsation. This style of pump is also known to be less robust, making it less reliable, which leads to potential increased downtime for maintenance and component failure.

Figure 3

Regardless of what pump is chosen, as the CO2 reaches the pump, it must either be as high-pressure gas or in a liquid state. As previously mentioned, only liquid and supercritical phases of CO2 have adequate solvent power to be used in extraction. It is important to note that if a high-pressure gas is delivered to the chamber, enough additional pressure must be built up within to produce a liquid or supercritical fluid. If the solvent is pumped as a liquid, no change of phase is required. However, an operator may wish to adjust the fluid temperature which would include potential selection of the supercritical phase, before the solvent reaches the extraction chamber.

PHASE AND EFFICIENCY

Importantly, the phase of the solvent as it is acted upon by a system’s solvent-delivery pump can affect the extraction machinery’s mechanical efficiency. Liquids are effectively non-compressible, meaning the force applied by the pump is used to efficiently deliver solvent to the system. Conversely, more work is required when applied to a volume of gas and this will be given off as thermal energy as the gas is compressed. This means, that when acting on a volume of gas, an amount of the output stroke’s energy is then converted to heat.

Delivering the solvent as a liquid incorporates further efficiency as the density (being the number of particles per unit volume) of gases, even under high pressure, is much lower than that of liquids. This means that two identical pumps, one primed with a volume of gaseous CO2, the other with an identical volume of liquid CO2, do not contain the same amount of solvent. The pump filled with the liquid CO2 contains more solvent molecules than the pump filled with gaseous CO2. This results in fewer pump strokes that are required to deliver a given amount of solvent when it is pumped as a liquid.

3. PHASE MANAGEMENT

Phase management is an optional stage during the extraction process. Temperature adjustments including those where a phase change is induced, can be made using a phase management system. To adjust the solvent temperature, the flow is directed through one or more coiled or folded solvent flow paths within heat-exchange bath(s) or vessel(s). These flow paths are designed to maximize the surface area and can be used to either increase or decrease solvent temperatures through the flow path piping.

From here CO2, either as a subcritical liquid or supercritical fluid, goes into the extraction chamber where the extraction process takes place, before following on to the separation stages. These stages will be covered in the ensuing two parts of this guided tour of a CO2 extraction system.

The Vitalis Difference - Phase Management_v2

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Extraction Fact vs. Extraction Fiction

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CLAIMS OF TIME & RECOVERY

Extraction as an industry is growing fast, and there are a number of companies vying for market share and consumer attention. In the CO2 space alone, there are dozens of companies supplying equipment to the industry. In this space, it's natural to see organizations trying a number of different tactics to get ahead.

Unfortunately, in the course of competitive business, statements can be made that are inaccurate and/or false. One typical myth that has had its time in the spotlight is the subject of yields. This topic can arise when people try to make simple comparisons between different types of equipment, and it is used as a measure of efficiency. However, as has been covered numerous times (check out this article), the subject of yields can be confusing and even misleading.

There have been numerous instances where the question "what is the yield on this machine?" is followed up with a simple numerical response like, "30%". Without even questioning the starting material going into the system, this can be misleading. If one were to use starting material that is 5% cannabinoids into a system, getting 30% yield would mean that most of the output would be non-cannabinoid material.

While the topic of yields and the confusion surrounding it has been discussed for years, a new subject of interest has come to light - percent extraction efficiency, also referred to as recovery percentage . The percent extraction efficiency is a number calculated by measuring the difference in cannabinoid mass between the feedstock and the post-extraction raffinate. As a simplistic example, if 100g of a specific compound existed in a specific volume of plant material, and the extraction output was measured to have 97g, the percent extraction efficiency would be 97%.

Unfortunately, while this topic has started to gain traction, so too have some of the myths surrounding the process. For example, some are reporting that they're hearing statements about the recovery percentage of a particular system within a specific period of time. For arguments sake, let's use the example of a 95% recovery in a run-time of 2 hours. These results are fantastic, but are they even possible? Keep reading to find out.

THE SCIENCE OF EXTRACTION

CO2 extraction is a process that has as part of its foundation a few key scientific principles. The key factors in an extraction are temperature, pressure, time, and flowrate. Under a set of parameters (temperature and pressure) during a run of a specific duration (time) and based on the overall volume of solvent passing through the substrate (flowrate), an extraction will produce a quantity of crude oil.

For different compounds within the biomass, different temperature and pressure settings can increase or decrease their solubility within the solvent. As well, the more time the extraction is given to run, the more of that particular compound can be extracted (this article talks about the "declining curve" of recovery that is typically noticed). Finally, the amount of solvent that is flowing through the chamber can also increase the overall efficiency of the extraction.

None of these factors are magical. Rather, they are scientific principles upon which extraction is based. The end result of the extraction is similarly based on the science. Given a specific set of parameters, the laws of physics, the phenomenon of mass transfer and solubility, an extraction occurs.

THE EXTRACTION CURVE

This image represents the extraction curve, or better put, gives a graphical look at the amount of cannabinoids that can be pulled from the plant material over time. The familiar "declining curve" shows that in the first part of the extraction, the majority of cannabinoids are recovered. As the solvent continues to penetrate the biomass, components that are further from the surface of the material take longer to recover. Over the course of the run, the remaining desirables are pulled.

Given the laws of physics and the physical properties of solvent and biomass, this shows what happens when appropriate temperature and pressure parameters are set when targeting cannabinoids. These parameters are chosen as they are the most favorable for extraction of target compounds with as little co-extraction of non-desirable components like fats and waxes.

THE UN-TRUTH

Technically, 95% recovery in 2 hours is possible. This can be accomplished by drastically increasing temperature and pressure settings during the extraction. Unfortunately, the by-product of such a process is the complete extraction of both desirable and undesirable compounds. This leads to a situation where post-processing requires greater amounts of time, energy, equipment and resources. In this case, maintaining these numbers indefinitely is neither profitable nor sustainable.

When evaluating claims that are made across the industry, it is wise to get the actual details behind the statement. If a claim like our example is heard, then the discussion should focus on the how - how is it possible to reach those numbers, and what are the downsides that also result? Similarly, hearing wild claims about the yield of a particular extraction system should be met with queries regarding the biomass. What are the percentages of desirable compounds in that plant material, and how does that compare to the claim (remember, 30% yield from a 20% feedstock is nothing short of magical)?

As the industry gains momentum, we can anticipate more outrageous and fantastic claims. As in most situations, regardless of industry or transaction, critical thinking pays off. Like the saying goes, “if it sounds too good to be true, it probably is.” While some “claims” can technically be true, the realities may not be close to the desired outcome. Educate yourself, purchase wisely.

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CO2 Extraction Without Winterization

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Carbon dioxide (CO2) is an excellent choice of solvent for extraction of natural compounds. The technology has been used successfully in commercial applications for over 40 years, including hop extraction, herb and spice extraction, oilseed extraction, and coffee decaffeination. CO2 is non-flammable, non-toxic, cheap, and readily available in large quantities at high purity. The extraction process is carried out at near-ambient temperature preventing damage to heat-sensitive compounds, and small changes in process temperature and/or pressure can result in large changes to solubility.

For these reasons, the cannabis industry has adopted CO2 extraction as an ideal method for cannabis oil processing. Cannabis is an extremely complex plant containing over 550 unique chemicals identified to date, including cannabinoids, terpenes, phenols, flavonoids, fatty acids, pigments, and other miscellaneous compounds. Typically, the cannabinoid and terpene fractions collectively make up approximately 10-30% of the mass of buds. Though the larger residual fraction contains many beneficial compounds, it is the cannabinoid and terpene fraction that the industry is focused on for extraction and purification.

UNDERSTANDING WINTERIZATION

In a typical CO2 extraction, extraction parameters can be tuned to produce crude oil that contains 45-80% cannabinoids and terpenes. The remaining portion will consist of co-extracted components from the feedstock that are either highly soluble in CO2 at the given processing parameters; or, have low solubility but are easily accessible and co-extracted with limited mass transfer resistance. A process called winterization can be employed to remove the co-extracted fraction. In this process, the extracted crude oil is mixed with another solvent and exposed to cold temperature to precipitate some amount of the undesirable co-extracted solids. The solids are then separated from the liquid through a filtration process, yielding what is known in the industry as a “winterized oil.” Depending on the desired outcome of the process, the oil may be further processed or purified or formulated directly into retail products.

Winterization can be a time-consuming process and can be a rate-limiting step in some cannabis processing operations. Because of this, many manufacturers are touting equipment that can eliminate the need for this additional process. However, these claims generally cloud the truth by avoiding discussion of the pros and cons.

Can winterization be minimized or eliminated? The answer is yes, but a better question to ask is should it be? Read on for some tips on reducing winterization in CO2 extraction.

You get what you put in.
In general, extracting feedstock with a high content of desirable constituents will yield an extract with a high content of desirable constituents (provided these constituents are easily extractable). In other words, starting with high-potency, terpene-rich cannabis feedstock will yield a crude extract containing a high cannabinoid and terpene content. Conversely, starting with a low potency low terpene feedstock (i.e. trim or industrial hemp) will yield an extract with a higher content of non-cannabinoid, non-terpene material that will likely require winterization.

Material Preparation.
Reducing particle size will increase the mass of feedstock that can fit into a given volume (increase density) and increase the extraction efficiency by reducing the distance the solvent must travel to reach the center of a particle. However, reducing particle size ruptures plant cells and exposes their interior contents to the solvent. This increases the likelihood of coextraction of undesirables, which require removal using winterization.

Extraction Parameters.
One of the benefits of CO2 extraction is tuneability; solvent power is affected by changes in CO2 temperature and density. Thus, extraction parameters can be tuned to favor the extraction of a compound or groups of compounds with similar chemical properties. For example, Perrotin-Brunel et al (2010) examined the solubility of pure THC in CO2 and found that at extraction pressures lower than 2175 psi, THC solubility decreased with increasing temperature (density-dependent), and at pressures higher than 2175 psi, THC solubility increased with increasing temperature (temperature dependent).

Many cannabis processors choose to use cold (<60 F), low pressure (<1200 psi) liquid CO2, as terpenes are highly miscible under these conditions. Liquid CO2 is very dense, having low selectivity and high solvent power towards high molecular weight compounds. Further, the solubility of major cannabinoids in CO2 at these parameters is low, so more solvent contact is needed and thus, more time is required if cannabinoid extraction is the goal.

Alternative Separation Methods.
There are alternative methods of separation that do not involve traditional winterization techniques. As with many technologies used in the cannabis industry, many have been adopted from other industries. Decantation, for example, can be used to separate immiscible liquids with different densities. In the food industry, a centrifuge is used to separate cream from skimmed milk. Another example would include nanofiltration, which can filter fats from oil without the need to first freeze and precipitate the fats as solids.

Not all products require winterization.
Perhaps the goal of the manufacturer is to make a “broad-spectrum” oil that contains all the components, plant fats and waxes included, originally extracted from the plant material. Such an extract would most closely resemble the chemical makeup of the original plant material. Raw crude extract can either be packaged as-is or diluted with a carrier oil to achieve a desired cannabinoid concentration. Typical products would include capsules, tinctures, and syringes.

Extraction without winterization is possible, but its application to business processes is reliant on the feedstock, preparation, and parameters. Alternative extraction methods provide some options, while product options provide more. However, in the typical day-to-day world of CO2 extraction, companies need to be sure that their end goals are compatible with the requirements and outcomes of a winterization-free process. If somebody tells you that winterization isn’t required, be sure you are clear on the intended results.

If you need more information on extraction, with or without winterization, the Vitalis science team is able to help. Work with a team of experts that can back up their claims with science and data; a team that consistently assists customers in understanding the nuances of extraction and processing.

References:
Perrotin-Brunel, H. et al. 2010. Solubility of Δ9-tetrahydrocannabinol in supercritical carbon dioxide. The Journal of Supercritical Fluids 52: 6-10.

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When Outfitting Your Lab, Choose CO2. Here’s Why:

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THE DIFFERENCES IN CANNABIS EXTRACTION TECHNOLOGIES

The cannabis industry today is comprised of three main extraction technologies; carbon dioxide (CO2), ethanol and hydrocarbons. Although these extraction methods are different, they all try to achieve the same objective of extracting valuable compounds from cannabis plant material. The main compounds targeted by these extraction systems are cannabinoids and terpenes, but each extraction method has its own respective advantages and disadvantages when extracting these compounds. Not only are the differences solely in how the compounds are extracted, but also extend to extraction safety, environmental impacts and costs. Having an understanding of these extraction methods is important when determining what cannabis extraction method to use. The characteristics that would be important for someone looking to purchase cannabis extraction equipment are discussed below for the three extraction methods mentioned.

CO2

CO2 in its liquid form can be used as an extraction solvent if its temperature and pressure are within the liquid phase range, or as a supercritical fluid if its temperature and pressure are above both 87.98 F and 1071 psi. It is an outstanding solvent for volatile compounds such as terpenes and, as a supercritical fluid, is good for cannabinoid extraction. The final separation of the solvent from the extract is achieved by a density drop that allows CO2 to evaporate from liquid or supercritical fluid to gas. The liquid cannabis oil that is left behind is free of any residual solvents.

Table 1: CO2 extraction system characteristics

Criteria CO2
Scalability Low to high
Infrastructure Required No significant infrastructure required
System Cost Medium to high
Product Options High; tuneability and terpene preservation allows for diverse product offering
Extraction Run Times Medium - long
Energy Usage Low to medium
Solvent Cost Very low
Tuneability Yes
Terpene Preservation Yes
Post Processing Winterization may or may not be required, depending on feedstock input and desired product formulation
Residual solvent in crude extract No residual solvent in extract
Pre-cool solvent No
Feedstock waste No residual solvent, general waste
Solvent Generally Recognized as Safe (GRAS) Yes
Safety High pressure
Solvent disposal Vent to atmosphere

The tuneability of CO2 and its ability to switch between a liquid and a supercritical fluid is a tremendous advantage for this process, and allows for a more diverse range of product offerings. Depending on the chosen parameters, extraction of undesirable compounds such as chlorophyll and lipids can be reduced, or a terpene pull can be completed using a subcritical run. As CO2 can extract at lower temperatures and pressures, subcritical parameters are good for targeting low molecular weight terpenes while leaving other components behind. Typically, with CO2 extraction, a post-processing step of winterization is required to remove undesirable compounds.

Another major advantage of using a CO2 extraction system is the relatively small infrastructure requirements. Unlike ethanol or hydrocarbon extractions that require a Class 1 Division 1 or 2 space, no specialized infrastructure is needed. This represents significant cost savings up front and helps mitigate the expense of the equipment.

CO2 extraction is the leader in safety in terms of residual solvent toxicity as well as environmental impacts relating to solvent disposal. Most extractors will reuse the CO2 or simply vent it to the atmosphere, saving on costly hazardous waste solvent disposal. CO2 is relatively inexpensive to restock, so even when levels need to be topped up, the costs are minimal. This is yet another area in which CO2 proves its affordability in the long run. With the savings on infrastructure, and the long-term costs of maintaining solvent stock, CO2 ends up being a more cost-effective process than the alternatives.

Ethanol

Ethanol extraction is best performed at temperatures below -40 °C, where the co-extraction of undesirables is minimized. However, cooling ethanol to these temperatures can require significant amounts of energy and time. Ethanol is a polar molecular, and this can create issues as it will readily mix with water and dissolve water soluble molecules such as chlorophyll. However, at temperatures below 40 °C this phenomenon is limited. During the extraction process, ethanol is passed over the cannabis material to dissolve the active compounds in the plant.

Table 2: Ethanol extraction systems characteristics

Criteria Ethanol
Scalability Low to medium
Infrastructure Required C1D2 or C1D1 space
System Cost Low to medium
Product Options Low to medium; poor terpene solubility means smaller product offering
Extraction Run Times Short to long, depending on solvent cooling duration
Energy Usage Low to high, depending on solvent cooling
Solvent Cost Medium to high
Tuneability No
Terpene Preservation No
Post Processing Winterization may or may not be required, depending on solvent cooling
Residual solvent in crude extract Solvent recovery required
Pre-cool solvent Below -40°C to minimize co-extraction of undesirables
Feedstock waste Residual solvent, hazardous waste
Solvent Generally Recognized as Safe (GRAS) Yes
Safety Flammable
Solvent disposal Hazardous waste

A major advantage of ethanol extraction systems is that they have a low cost of entry. However, due to ethanol’s flammability, infrastructure to support such an extraction system is more costly due to the requirements for hazardous locations (C1D1 or C1D2 – which means there is an ignitable concentration of flammable gas or vapour that has to be contained).

Terpenes have low solubility in ethanol which results in an oil that can lack flavour and aroma, and a reduced product offering for the extract. What ethanol excels at is cannabinoid extraction and it tends to have shorter extraction run times which is highly beneficial for throughput. The tuneability of the ethanol extraction method is very low and is primarily used to target cannabinoids. Ethanol, like CO2, is also generally recognized as safe (GRAS) for consumption by the FDA. But an important consideration is solvent recovery as residual solvent in the product could harm end users. Furthermore, ethanol waste is classified as hazardous, which in turn requires special handling and disposal.

Butane

Hydrocarbon extraction equipment typically uses butane, propane, or hexane as the extraction solvent (although most commonly butane). Cold butane is washed over the cannabis material, which slowly dissolves the cannabinoids and terpenes. As it is non-polar, it binds to the more fat-soluble components of the plant (cannabinoids, terpenes and lipids) and less so to chlorophyll and other plant metabolites. As it has a low boiling point (-0.5°C/31.3°F), very few temperature sensitive terpenes are lost when boiling off the residual solvent from the concentrate solution.

Table 3: Hydrocarbon extraction systems characteristics

Criteria Hydrocarbon
Scalability Low to medium
Infrastructure Required C1D1 space
System Cost Low to medium
Product Options Medium to high; terpene preservation and cold processing allows for diverse product offering
Extraction Run Times Medium
Energy Usage Low
Solvent Cost Low to medium
Tuneability No
Terpene Preservation Yes
Post Processing Winterization may or may not be required and desired product
Residual solvent in crude extract Solvent recovery required
Pre-cool solvent No
Feedstock waste Residual solvent, hazardous waste
Solvent Generally Recognized as Safe (GRAS) Yes (for butane)
Safety Pressurized and explosive
Solvent disposal Hazardous waste

Butane extraction is excellent for the extraction of cannabinoids and terpenes under the same conditions, and when done properly can produce a terpene-rich end product that closely resembles the starting plant material. This process tends to produce great tasting concentrates like shadder, budder, sauce and more.

However, butane and other hydrocarbons are highly flammable and volatile, which means there are strict regulations that surround butane extraction systems. Again, like ethanol extraction, a hazardous location space is required, and a solvent recovery step is needed following extraction. The spent butane is also classed as hazardous waste and appropriate environmental disposal is required.

While ethanol and butane extraction systems have their place in cannabis extraction, CO2 has proven itself to be one of the most adaptive and safe cannabis extraction methods. The CO2 extraction process is well known for its low up-front infrastructure cost, safe solvent use, scalability, and tunability. These factors, along with its long-term environmental sustainability, make CO2 an excellent choice for cannabis extraction.

High-Volume Extraction

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WHY YOUR CHOICE IS CO2

With harvest imminent, many businesses are examining extraction systems that have the capacity to process large volumes of biomass. When considering options to deal with these quantities, ethanol extraction tends to be top-of-mind. Ethanol is well known for its ability to perform extractions with short run-times, meaning more batches per day and more volume processed. However, with advances in technology and manufacturing practices, extraction using CO2 has become part of the high-volume conversation.

In the past, CO2 hasn't been a viable option due to the size of the systems available. Prior to the last two years, most CO2 extraction systems were limited to 40L or less. In those cases, to manage high-volume extraction, processors would require fleets of systems and the people to operate them. This could be inefficient and cost prohibitive.

As the industry has progressed, companies have started to manufacture larger, industrial-scale systems to meet the needs of extractors. Where the Vitalis Q-90 system was once considered massive in CO2 extraction, the R-400 series system has become the focus for many new customers. Working with OEMs like Vitalis, processors are also able to build custom, factory-scale systems to meet their needs. As technology and innovation moves forward, standard production systems with even greater capacity are on the drawing board, reducing the need for multi-unit deployments.

Here are a few more reasons why CO2 should be top-of-list when considering high-volume extraction.

CAPITAL EXPENDITURE VS OPERATING EXPENSE

CO2 extraction equipment has a reputation for being expensive. When looking at the initial capital expenditure, these systems tend to be higher on the cost scale than many other options, and that expense increases as higher capacities are required. Unfortunately, the true affordability of CO2 extraction can be missed if consideration is only given to equipment acquisition cost.

While ethanol extraction equipment can be relatively inexpensive compared to CO2 solutions, the ongoing costs to replenish solvent are substantial. As well as the expense necessary to keep solvent in stock, additional engineering bills - necessary to ensure facilities meet regulations for working with flammable and explosive substances - can drive the overall cost of ethanol extraction into the millions.

For high-volume processing requirements, the cost of solvent increases relative to capacity. The more biomass to be processed, the more solvent required. The cost-per-litre of ethanol is certainly higher than CO2, and this is a standard operating cost that is required for as long as extraction processing is to continue. CO2 equipment can be expensive to obtain, but ethanol is expensive forever.

CO2 is an inexpensive solvent to keep stocked, and extraction facilities typically require little to no specific engineering in order to pass safety inspection. At pennies-per-litre, the operating expense to keep CO2 stocked is far more affordable than ethanol alternatives. Despite the increase in solvent required to process large volumes, the minimal rise in cost is far easier for businesses to handle. When combining both capital expense and operating expense, CO2 is much more attractive from a dollars and cents investment perspective.

GMP

GMP (Good Manufacturing Practice) considerations can also increase the operating expense for ethanol extraction systems. GMP requires that substances that come into contact with the product do not alter the product quality. While the solvent power of ethanol makes it a great choice for extraction, it also makes it extremely difficult to avoid batch-to-batch contamination while re-using ethanol for multiple runs. Even with a wealth of costly post-processing equipment, recovered ethanol will typically contain residuals of the compounds extracted from the previous run. Further, validating ethanol as clean and free of contamination could be a large challenge.

To achieve GMP compliance, ethanol processors may have to replace the solvent for each extraction batch, adding hazardous waste disposal as an additional operating expense. Even in situations where solvent recovery and re-use is possible the operating expense is high. In the case of high-volume extractions, where the solvent would need to be replaced after each run, the costs necessary to meet GMP requirements would be astronomical and unfeasible for many companies.

SELECTIVITY

As well as cost considerations, using CO2 systems for high-volume extraction also provides one significant advantage: selectivity. The tuneability of CO2 as a solvent has made it a popular choice for processors wanting to make a wide variety of products. The ability of CO2 to extract specific target compounds based on the parameters of extraction is one of its most beneficial attributes. Using it for extractions of large quantities of biomass doesn't diminish this ability.

With the investment necessary for high-volume extractions - from cultivation and cost of biomass to equipment and facility purchases - a sudden shift in the market from one type of product to another can spell disaster for processors that can't adapt. With CO2, adapting to market changes can be as straightforward as changing the extraction parameters, and making minor changes to post-processing practices. Even without significant market changes, using CO2 provides the opportunity for processors to make a wider spectrum of end products and ensures overall business stability and longevity.

CO2 MAKES SENSE

Given the advantages CO2 brings to the extraction lab, using it for high-volume extractions makes sense. With the capacity of systems getting larger and larger, the ability to use it as a go-to process is getting more affordable and efficient for processors. As well, new markets in Europe, where GMP is the standard, forcing companies to examine CO2 as an option in order to gain access.

Where ethanol was once the method of choice, examination of the overall cost of operation reveals a process that can create financial challenges and risk to processing companies. Further, the challenge required of ethanol processes to feasibly meet GMP standards can see companies shut out of a burgeoning market entirely. CO2, having recently closed the gap on capacity, and being far more affordable in the long run, has become an attractive option for large volume operations. With the summer harvest season, the time is right to investigate all that CO2 extraction has to offer.

If you’d like more information or solutions to process large volumes of biomass, give our Accounts team a call. With high-capacity extraction systems, and end-to-end ancillary services available, the Vitalis team can help you maximize profits and efficiency in your extraction efforts.