Tag Archives: carbon dioxide

Hemp-Derived Products with a Contract Manufacturer

By Aaron G. Biros
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Based in Santa Monica, California, Sagely Naturals was founded in the summer of 2015, with the goal to produce a sustainably sourced, topical CBD cream with no psychoactive effects to treat daily aches and pains. The co-founders, Kerrigan Hanna and Kaley Nichol, have extensive backgrounds in the food service industry, and as a result they pride themselves in quality controls and proper safety procedures. Since the launch of Sagely Naturals, they have been selling their Relief & Recovery Cream online and in a wide variety of retail outlets beyond just cannabis dispensaries. Their ability to distribute outside of dispensaries is due to the fact that the product’s active ingredient, Cannabidiol (CBD), is derived from hemp, instead of cannabis with higher levels of Tetrahydrocannabinol (THC).

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Co-founders Kaley Nichol (left) and Kerrigan Hanna (right)

Their attention to detail in consistency and quality makes them stand out as cannabis processors, using a contract manufacturer with good manufacturing practices (GMPs) along with the proper standard operating procedures (SOPs) in place. “All of our contract manufacturer’s corrective and preventative actions (CAPAs) are outlined in the company’s SOPs, which are in place for everything including specific manufacturing processes, receiving and shipping materials and testing batches,” says Hanna. “The contract manufacturer also provides certificates of analysis (COAs) for every product they make.” According to Hanna, they exclusively use current GMP-certified facilities. One such SOP lays out the responsibilities for the quality control department in order to release and approve ingredients of their products.sagely_naturals_logo_400x400

There are some SOPs that could pertain specifically to the processing of hemp or cannabis products, according to Hanna. “Receiving and handling raw materials like hemp, batch coding, the actual formulation and manufacturing process, quality controls and cleaning and sanitation [could be tailored to pertain to cannabis],” says Hanna. Proper SOPs laid out in the manufacturing process include the cleaning and sanitation of machines, as well as adjusting settings, formula ratios and initialing and dating product labels on every batch, among more specific operating procedures.

The cream is made with natural ingredients like safflower seedily and peppermint.
The cream is made with natural ingredients like safflower seed oil and peppermint.

According to the co-founders, they spent a large amount of time vetting their hemp supplier, making sure they are using cutting-edge technology, growing it sustainably, and adhering to strict SOPs. “The team includes a Ph.D. chemist, who also is a founding member of our supplier and extractor,” says Hanna. “We work with CO2 extraction because we wanted the most control over the compounds that end up in our product. We are able to purposefully choose which cannabinoids end up in our product.” Through supercritical carbon dioxide extraction and post-extraction processing, the team is able to eliminate any trace of THC, guaranteeing the consumers will receive no psychoactive effects.

In looking toward long-term growth, the co-founders emphasize the importance of environmental sustainability. “Having honest ingredients is one of our company missions along with having honest practices,” says Hanna. “None of our ingredients are tested on animals so we are an animal cruelty-free organization.” Their hemp is grown using organic and environmentally friendly practices. “We prioritize using plant-based ingredients, so the formulation of our Relief & Recovery Cream relies on using organic and raw materials—such as essential peppermint and safflower oil.” Companies like Sagely Naturals using contract manufacturers to process hemp could represent the future of the cannabis industry. When safety, sustainability and quality issues come into the spotlight more, so will the need for outlined SOPs, proper documentation and extensive lab testing.

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BEST Extractions

Defining BEST Extraction

By John A. Mackay, Ph. D.
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Over the next few months, I would like to walk through a series of articles to cover the number of ways to extract potentially pharmaceutically active compounds from cannabis plants. However, in the first article I would like to review concerns being addressed in state regulations: contamination in concentrates with pesticides, mycotoxins, and residual solvents. The next article will cover the most common extraction with two different modes: CO2 versus hydrocarbons.

Currently, there is a lot of focus on the cannabis strain of hemp. This is defined as having less than 0.3% of THC, (the psychoactive compound). To be clear, the science of extraction is eons old, but the current revitalization is due to new scientific inquiry regarding the applications of the cannabis plant.

I am often asked, “What is the ‘best’ extraction for a natural product?” The BEST extraction? The key to this answer is that you must assume unintended consequences until you can prove that they are at least minimized compared to the intended consequences.

I have a suggestion for you to consider and I look forward to your response to it. I also assume the right to adapt and revise it.

Botanical integrity from seed to shelf

Efficacy of the process beyond efficiency, economics, effectiveness

Safety of people and product

Testing for confirmation at each step of process

The hemp industry has changed significantly over the past few years. Just casually flipping through the channels on television, reading a newspaper or magazine, (on any topic – news, business, sports, food and science) and there is some facet of hemp’s value being examined. The reduction of traditional pulmonary intake (smoking) in the legal marketplace can be tracked by sales of these products in the states where it is legal. The balance of ingestion is drastically tipping toward what might still be considered smoking with vaporizer products as well as toward edible consumables. The ingredients in these products come not from just adding the plant to the formulation, but rather a concentrated mixture. This is the difference between adding a raw vanilla and a teaspoon of vanilla extract. The compound getting the most coverage is cannabidiol (CBD), which is the compound derived from cannabidiolic acid (CBDA). The effects of the other compounds in the plant are being studied as well.

Unintended consequences from the concentration – extraction – are something we need to consider seriously as consumers. The labeled use of “natural” is one that is critical, but can be totally nullified by the unintended contamination in the extraction workflow. Years of making sure the hemp adheres to strict growing environment can be destroyed in seconds with the addition of polycyclic aromatic hydrocarbons (PAH’s) by the use of solvent that has these toxic chemicals in them. These come not through intended consequences, but not knowing the stabilizers and other additives in material being added to these previously pure plants.

What if I pour sour milk on a natural granola for breakfast? What if I use water with high lead or contaminated water to pour over natural coffee grind? Not a great way to start the day, but it is no different than using the most premium hemp and unknowingly adding low grade solvents or adding components from cleaning the surfaces of instruments that come in contact with hemp.

Note that, by definition, we are concentrating the material from the hemp plant. From 4,000 grams, we are getting 400 grams of CBDA if it is 10% by weight (and later converted to CBD). That compound is 10 times more concentrated in a solution. What other compounds are now also 10 times or 5 times or 100 times more concentrated? Maybe no “bad” ones, but how do you know that something else is not also in the mixture?

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Figure 1. With each step of concentration of the green balls, so it could be with other components in the mixture.

This is illustrated in the filtering of green balls in Figure 1. As the green balls become a greater and greater percentage of the solution, it is possible that other compounds like pesticides are also increasing in percentage of the extraction solution. The solution is more concentrated and “simpler” versus all of the other things in the original mixture.

The simple answer is in the testing of the components. The labeling of major compounds is only the beginning of what is on the label that you read. Heavy metals? PAH’s? Residual solvents? Pesticides? Molds? And a long list of other material that could come into the process after the plant left its pristine organic farm. Many studies can be read about slip agents in bags, contamination from workers in the workflow, and other sources of inconsistency.

There are a significant number of companies that I have seen that take this very seriously. New companies are being formed that have safety of product at the top of the list of importance. They are building facilities that are sterile and putting standard operating procedures in place that continually test the product along every step to ensure that they are in compliance.

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Figure 2. Science and economics merge when considering all the possible uses of concentrated compounds to final product formulations

Supercritical fluid extraction is GRAS (generally regarded as safe). It is, only as long as the solvent specifications are known, the vendor meets those standards, and the instrument surfaces meet any necessary standards.

Supercritical carbon dioxide is used to clean surfaces of electronics and bones for skin grafts. It is used for the decaffeination of coffee as well as pulling trace amounts of pesticides from soil. It is used to extract antioxidants from krill and the active ingredients from algae as well as oil from core samples deep below the earth. It also extracts the terpenes and CBDA from hemp – as well as possibly anything that has been added to it.

The key take away from this article is to know the BEST extraction.

Botanical integrity from seed to shelf

Efficacy of the process beyond efficiency, economics, effectiveness

Safety of people and product

Testing for confirmation

Taking each of these into consideration will bring the best results for concentrations of hemp products. I hope you can extract the best from your day.