Someone approached me the other day, wanting to know what was the real story about hemp and CBD.
He said he had “a guy” who gave him a CBD salve as part of a study, supposedly “the good stuff,” to help his knee. He couldn’t understand why he was the only one out of 20 people in the group that felt no relief. He happened to have this CBD salve with him, along with a second brand that he hadn’t yet tried. The “good stuff” had slick, colorful packaging, a beautiful logo and powerful marketing messages about the phytocannabinoids and essential oils in the jar. The other CBD product was in a dull grey tin, an ugly duckling, and not nearly so impressive on the outside- I’ll call it “Homer’s Brew.” My friend dismissed Homer’s Brew outright, as not even worth trying. I told him that not all CBD products are created equal, that you can’t always believe the claims on the package, including the cannabinoid potency displayed on the label.
I told him to search for the Certificate of Analysis (COA) for each of the two products, specifically, lab test results validating the CBD dosage per serving, and also the breakdown of pesticides, heavy metals and microbials. He had to do a little digging and emailing, as it wasn’t readily available for either company, but the next day, results were in. The “good stuff” with the slick packaging and bold claims had mere trace amounts of CBD, with some hemp and essential oils- no tests for pesticides or contaminants of any kind. Hmmm, no wonder he was disappointed. Homer’s Brew’s COA came in with flying colors – a reputable lab had confirmed safe levels of pesticides, pathogens and heavy metals, and the CBD level was substantial, with a detailed cannabinoid breakdown in the lab report.
In spite of the varying legality of hemp-derived CBD products from one state to the next, consumers are gobbling up costly CBD salves, tinctures and edibles in markets, gyms and online. Like moths to a flame, they are pulled in by the CBD name and lofty promises, not always understanding what they are getting for their money. They trust that these products are safe, licensed, inspected and regulated by some agency, otherwise, “they wouldn’t be on the shelves, would they?”
In spite of the 2018 Farm Bill, FDA still has not recognized the legality of products containing hemp-derived CBD, but some states have gone ahead and given them a green light anyway- check with your own jurisdiction to be sure. In the meantime, hemp-derived CBD products are slipping through the regulatory cracks, depending on the state. It is confusing, for sure, and buyer beware.
Separate yourself from the pack of snake-oil salesmen. Test your products for safety and accurate cannabinoid potency, and make a Certificate of Analysis readily available to your customers. Boldly portray your transparency and belief in the quality of your products through this COA.
Providing this information to consumers is the best path to success- safe, satisfied customers who will refer to their friends and family, and most likely come back for more of your “good stuff.”
In other words, decidedly less colorful (or at least in the North American sense) if not at lower volume than other places.
In the meantime, particularly filtered via American and Canadian coverage and industry success stories, the British are succumbing to the green magic any way they can.
Low-THC, CBD products as a result, are flourishing in a way that seems a bit like the “Colorado of Europe.” The early days. When all sorts of strange stories about processing leaked out of the first legalizing state market in the U.S. It is shocking to European eyes, in particular, of late.
“CBD” is, literally, everywhere.
For those with other kinds of experience in the world of cannabis, however, it is both slightly sad and slightly exhilarating. The Brits have the cannabis bug. But they seem a bit lost on where to go next.
What Is The Deal In The UK?
Regulations are weird here. You cannot use the flower of any cannabis flower (including those with under the requisite amount of THC) – also known as hemp. The novel food discussion is lost.
Regardless, there are clearly plans afoot, particularly on the corporate farming level, to begin a transformation of crops to include cannabis sometime soon. And far beyond the farmers, the boys in the city are getting hot under the collar for this kind of green.
London is also turning into (rather predictably) a center of all things cannabis equity.
There are already more specialty funds planning to list on London exchanges than anywhere else in Europe.
But is this all that surprising?
In the midst of Brexit, a failing NHS, and a society at odds with itself like no time since the 1970’s, the British are facing the cannabis revolution with anything but a stiff upper lip.
When it comes to all things cannabinoids, at least on the CBD side, no matter the odd police raid on a health food store or crunchy vegan experiment on land not protected by the rights of an inherited “country pile”, the cannabis horse, certainly of the broadly stroked CBD variety, is out of the barn.
But What Does this Really Mean?
For the moment? As globally financed companies set up in the UK for all kinds of cannabis trials, the CBD market here is taking on an oddly Bulldog twist.
There is more of a cottage industry of all kinds of CBD products unseen elsewhere in Europe (including from the U.S.). Labeling, testing and sourcing are largely a matter of hit or miss. And just like everywhere else, desperate, sick, depressed people (or those who fear becoming that way) are turning to the CBD miracle to fix a range of conditions.
The problem is that a lot of this is pure snake oil.
Yes, high quality, medical grade CBD does work as a stabilizer (just like THC). But not every oil containing some measure of highly diluted (or worse, contaminated) cannabinoid extract, is the panacea that cannabis offers.
Bottom line? The CBD market in the UK is sort of like Swiss Lite. There are medical trials in the offing, but the country is also in the middle of a constitutional crisis. There are many regulations, and of a bit more fundamentally intrinsic kind, on the line right now. Cannabis is in the room. But so is the Irish Border (the largest if not most existential sticking point in the never-ending Brexit negotiations).
Investing In The UK CBD Market
There are investors who are clearly examining the market, and a few big deals so far, but the vast majority of money flowing into the UK is going into its more flexible (if not frothy) equity market. The British, in other words, may be flailing a bit on domestic implementation, but equity funds in London are in touch with global investors on this issue – even if that money then flows back into Europe.
The cannabis industry is on the road to legitimacy, no matter the bumps, globally. No matter what, and no matter what happens next, that is a good thing. Issues like supply chain transparency, privacy, consumer and patient safety, and of course energy and water use have long been in the room just about everywhere.
Cleantech Is Cannatech
The modern cannabis industry was birthed and given significant shape in deserts (Israel, California, Nevada). In California, as of 2014, producers were warned, yet again, that they could not avail themselves of federally overseen aquifers of groundwater. The legitimizing industry trucked in what it needed.
On the medical discussion, in Europe, in particular, such issues are now in the room. All medical cannabis must be grown indoors. No exceptions.
That means low energy, high efficiency production is on the rise, not the wane.
What Does GMP Mean?
The overall regulations and operating procedures that surround this discussion are known as “Good Manufacturing Practices,” or GMPs for short. But like all the best acronyms, what the standards are, who sets them, and where they are equivalent is still a shifting picture.
Further, GMPs, and even more particularly EU-GMPs, are specifically referred to this way to distinguish the medically bound product from other consumer protection regulations that include novel food.
That said, “GMP practices” differ widely from industry to industry. The idea behind them, however is to prevent harm from occurring to the user, including that the end product is free from contamination, and the packaging as well as manufacture has been well documented. Additional requirements include that personnel are properly trained.
And while the practice, at the pointed end of enforcement can get nerdy, detail-oriented and specific, that is precisely the point. That is also why you might catch another variant of this acronym (cGMP – or current GMP guidelines), to denote a world that is changing fast.
Contamination of the supply chain if not the carbon impact of the same, for all food and plant-based pharmaceutical products is a 21st century problem that is exploding on the scene as fast as the planet warms and cannabis legalizes.
What Do GMP Guidelines Include?
These are guidelines, not steps. As a result, from a bird’s eye view, all international and sovereign national GMP standards include a few basic principles no matter how much they may differ in the weeds. Namely:
That manufacturing processes are clean, controlled and processes are verifiable and repeatable. Changes to any and all must also be clearly documented.
Record keeping, accurate accounting (of product and on the financial side) must be kept, including complete batch history through manufacture and distribution to the end user. Audits are a way of life.
Recall procedures must be in effect.
All complaints about products must be examined.
The World Health Organization (WHO) version of GMP is what’s used by pharmaceutical regulators worldwide. The European Union’s EU-GMP standards are seen as roughly equivalent, as are those now practiced in the U.S. by the FDA. That does not mean that confusion does not reign as standards are changing (across Europe, for example, between individual countries, there is still disagreement). However similar GMPs are used in countries including Australia, Canada, Japan, and Singapore. The UK, of course, is slightly different than anyone else but still has regulations that are roughly equivalent and referred to as “The Orange Guide” (in honor of the color of the book’s cover).
You Know It When You See It
Well, not quite. Beyond GMP, there are of course, other classifications for the kind of plant or product being made, manufactured and distributed. And here, along with international treaties about who can trade with whom, also impact this discussion.
It is not correct, however, for example, to claim that what are known as GACP guidelines (good agricultural and collection practices) are equivalent to GMP. Bio, or pesticide free production (in other words) is just one of many steps in meeting much higher standards now in the room for medically bound cannabis.
What Is GMP “Like”?
All industries have “best practices.” For example, the building industry has all sorts of codes and guidelines. However, in addition to this, about a decade ago, LEED (or green building) certification began to be implemented widely. In the U.S., in particular, there was much discussion about how honest such certifications actually were. The term “greenwashing” was frequently used to describe practices that were sold as energy efficient, but in the end cost more, environmentally and otherwise, than they should.
Like LEED, GMP is not a prescribed set of steps but rather best practice guidelines and regulations meant to guide industries on producing safe products – from seed to sale.
How Does This Differ From WHO Guidelines on GACP for Medicinal Plants?
The World Health Organization’s GACP guidelines are highly controversial in this context, especially when it comes to cannabis. Especially because they refer specifically to plants used as medicine that are “grown in the wild.” I.e. not greenhouse. How these guidelines are interpreted by different countries, however, within the context of the interpretation of “medical cannabis” not to mention pharmaceutical GMPs, are very different.
GACP guidelines, in other words, are sometimes the first step in qualification – but certification under the same (starting with outdoor grown crops produced without pesticides for example) is not likely to pass European medical standards any time soon.
Since medical cannabis was legalized in Ohio in 2016, companies that cultivate and process medical cannabis, as well as the plants themselves, have been popping up around the state.
Grow Ohio, a dual-licensed Level 1 cultivator and processor, was the first licensed processor in Ohio and the first to successfully bring product to market. From plant material to edibles, tinctures, oils, lotions and capsules, the company seeks to ensure that medical cannabis is cultivated and processed under the same strict standards as any pharmaceutical medication. As first to market, Grow Ohio found themselves navigating a complicated process by themselves.
As their first product was ready to be packaged, Executive Vice President (EVP) Justin Hunt and the team at Grow Ohio were focused on marketing, packaging and distributing their product. With the sheer number of items that required attention, it is easy to see how something like labelling can slip under the radar. With a variety of products and dosages, and the first delivery of the product slated for late April of 2019, Grow Ohio needed a consistent way to ensure their product complied with state law, and also satisfied their own brand standards.
As their April product launch date grew closer, Grow Ohio realized they needed help with executing on Ohio’s labeling requirements for medical cannabis products.
They turned to Adaptive Data Inc., a barcode and labeling systems supplier to provide labels, printers, and software. ADI’s task was to specify the right label materials for their branding and compliance needs and provide software and equipment to print compliance labels on demand. ADI’s proposed solution would slash the waste associated with printing and applying labels and create a lean process.
Compliance labels must contain specific information and must be prominently visible and clearly legible. Containers have to be labeled with details including the specific quantity of product, dosage, THC levels, license #, testing lab name and ID #, and other details. Different sizes and shapes are required for the various packaging form factors.
Due to the large amount of content and a relatively small label area, ADI specified 300 dpi printer resolution so that 4 or 5 point fonts would be legible.
Hunt had all the information needed to comply with state regulations, but didn’t have a way to get that information, properly formatted, onto a finished label at the point of packaging. “It’s all about how you get the data from one source to the other in a way that is easily repeatable,” says Hunt. The solution provides the capability to handle all compliance requirements, for all types of product and all sizes/shapes of labels. The system is designed to minimize key entry of data, a typical source of content errors. All of Grow Ohio’s products contain THC and require the red THC compliance logo. Early on this requirement was met using a separate, hand-applied THC logo label, which was very costly. The labels now include the THC logo, all required compliance data, and the capability to include a 2d barcode.
At the time the products are packaged all compliance information is printed on demand with label printers. As retail expansion continues, the barcode on the plant material compliance label can be used with the POS systems of the dispensaries, to keep their systems fast and accurate.
Until the system is ready to receive data automatically from METRC, the State approved inventory system which tracks all medical cannabis plants and products grown or produced in Ohio, they used user interfaces that reduce the amount of data that is key entered to an absolute minimum. Using drop down lists, date pickers and calculated results, means that Grow Ohio only enters data in 5-10 fields, depending on product line. As the system evolves the next step will be to take data for compliance details automatically from METRC.
As the first to enter the medical marijuana market, Grow Ohio leadership knew that their brand image is as important to their success as the quality of their products. Their logo, color choice, and inclusion of the THC logo had to be consistent in appearance across all products, regardless of production method. They used full color branded product labels and blank labels that have the Grow Ohio and THC logo pre-printed. (Compliance data is added to the blank labels on demand.)
Label Application – Automatic, Semi-automatic and Manual
Grow Ohio packages in metal cans, glass bottles and in boxes. Each packaging type has specific requirements.
Metal Cans: Grow Ohio uses an automated packaging line for plant material in cans. That line includes two automatic apply-only machines (for brand labels). The compliance label is printed and dispensed and placed on the can as it is boxed.
Bottles: Cylindrical containers can be difficult to label. Grow Ohio originally packaged tinctures and oils in glass bottles which were pre-printed with their logo. The printed logo looked nice, but printing on the glass was expensive. This made placing the compliance label on the bottle more difficult, since the logo could not be covered. Positioning and straightness was critical for readability as well as aesthetics. Manual placement was time consuming (15 – 30 seconds per bottle).
Now, bottles are being processed with the help of a semi-automatic print-apply machine. The print-apply machine can label 18-20 bottles per minute.
By using plain bottles and pre-printing the blue Grow Ohio logo and red THC logo on the label, they were able to streamline the process. The semi-automatic print-apply machine adds the compliance data to the label and applies the label to the bottle.
The result is a lower total cost of the product. Plain bottles cost less without the logo and the labor to manually apply the labels has been greatly reduced. In addition, with the logos on the label instead of the bottle, orientation and spacing are no longer an issue. The label maintains the natural brand feel, which was important to Hunt.
Boxes: Only compliance labels are required for boxes as the branding information is pre-printed on the box. Compliance labels for boxes include a pre-printed, red THC logo. The printer prints the compliance data and presents the label with the liner removed, ready to be manually applied to the box.
With a broad product line, Grow Ohio’s label requirements are quite diverse. By specifying and sourcing the right hardware, software and label materials,
Adaptative Data provided an efficient, repeatable, cost-effective way to do brand and compliance labeling for Grow Ohio’s diverse product offering.
Hunt now understands the magnitude of work that goes into coming up with a compliant, cost-friendly compliance labeling approach – an appreciation he did not have at the outset. He is not alone in this regard as many companies come to this understanding late in the start-up process.
Hunt isn’t sure how fast the market will grow, but he is not worried. As the market expands and demand grows, he knows his systems can handle it.
Encore Labs is a full-service cannabis testing lab in Pasadena, California, providing all testing needs required by California’s Bureau of Cannabis Control (BCC). The BCC requires that cannabis products being sold in licensed dispensaries be tested for cannabinoid potency, heavy metals, microbial impurities, moisture content and water activity, mycotoxins, residual pesticides, residual solvents and processing chemicals, foreign materials and terpenes. It is Encore Labs’ goal to guarantee the quality and potency of all cannabis products while ensuring regulatory guidelines are met in the state of California.
Encore Labs provides quick turnaround times on a consistent basis. They take pride in offering excellent customer service without diminishing the quality of the work that they do. Their team of laboratory analysts/technicians are passionate about the industry and will never compromise their integrity just to make an extra buck.
Co-Founder, Spencer Wong, mentions their personal connection with clients. “Our customers don’t just see us as their testing laboratory, they see Encore Labs as their laboratory partner,” says Wong. “Besides performing analytical testing, we have worked with many customers to help formulate new products and do root cause analysis to pinpoint inefficiencies in their manufacturing operations and cultivation farms.”
ISO/IEC 17025 Accreditation has been extremely valuable to Encore Labs, especially regarding the new cannabis testing industry. “Our experience with Perry Johnson Laboratory Accreditation, Inc. has been great and has allowed for a very smooth and straightforward initial accreditation process. Their staff has been knowledgeable and responsive every step of the way,” says Wong.
Accreditation establishes that steps are being taken regarding quality and that laboratories are meeting and exceeding the highest testing standards. It also provides further assurance and confidence in data results as well as validated methods, staff training procedures, equipment calibration and successful participation in proficiency testing/interlaboratory comparisons.
Starting out with 1500 square feet of laboratory space, within the last year Encore Labs has doubled its work area. In order to meet the growing demand of the cannabis testing industry, they have added plans to once again double in size by the end of 2019, as well as open a second laboratory by the end of 2020.
On Tuesday, October 1, the National Cannabis Industry Association (NCIA) announced the release of their whitepaper, which provides guidance to the federal government on how cannabis could be regulated at the federal level. “The paper highlights the need to have a clearly defined regulatory approach and structure prepared as the nation moves closer to making cannabis legal for adults, and identifies the existing agencies best suited to regulate the wide variety of cannabis products available in state-regulated legal cannabis markets,” according to a press release.
Importantly, Kline also discussed the white paper and its four-lane approach to regulating cannabis at the federal level. “We believe rescheduling is bad public policy,” Kline mentioned during his keynote. Their stance is that cannabis should be rescheduled and regulated in a couple of different approaches. “We believe cannabis should be a public health issue and the FDA and the Department of Treasury should regulate cannabis much like they do alcohol.” Kline went into great depth later in the talk, discussing the four-lane plan for regulation, a state of affairs for cannabis bills in Congress and how members of the cannabis industry can get involved. “Right now, there is an unsustainable federalism clash, with cannabis as an illegal schedule I narcotic, while 33 states have legalized it, which leaves a lot of confusion in the marketplace and little protections for consumers; and we need to fix it.”
Lane 1 refers to pharmaceutical drugs, such as Epidiolex, where cannabis drugs can go through the new drug approval process, giving the FDA ultimate regulatory authority in this area. Lane 2 applies to ingested, inhaled or topically applied products with THC. This generally applies to all products containing THC. This lane gives regulatory authority to the Alcohol, Tobacco, Tax and Trade Bureau (TTB), essentially regulating cannabis like alcohol or cigarettes. Lane 3 is for ingested and inhaled products with less than 0.3% THC. These would be regulated like dietary supplements and food ingredients, giving the FDA regulatory oversight here as well. Lane 4 applies only to topical products with less than 0.3% THC, regulating them much like the FDA does with cosmetic products.
The above summary is not thorough or detailed. We highly encourage our readers to read the full whitepaper to understand how cannabis could be regulated at the federal level and how the NCIA thinks the government should do so.
“As a country, we are starting to move past whether we should end cannabis prohibition, and need to put serious consideration into how we do that and what a post-legalization world looks like in terms of federal regulatory policy,” says Aaron Smith, executive director at NCIA, in a press release. “The recommendations outlined in this report build on successful methodologies by assigning regulatory duties to existing agencies, while avoiding restrictions that would not be appropriate for cannabis as well as some of the missteps that have occurred with other products. We look forward to working with Congress to overturn our outdated federal marijuana laws and begin implementing this structure to help ensure public safety and displace the illicit cannabis market.”
The 1st Annual Cannabis Quality Conference & Expo featured dynamic discussions both in the sessions as well as on the exhibit floor. Take a look at some of the highlights from this year’s conference and expo.
The cannabis industry is growing exponentially, and the use of cannabis for medical purposes is being adopted across the nation. With this boom in cannabis consumers, there has been an increasing need for knowledge about the product.
The role of testing labs has become crucial to the process, which makes owning and operating a lab more lucrative. Scientists testing for potency, heavy metals, pesticides, residual solvents, moisture, terpene profile, microbial and fungal growth, and mycotoxins/aflatoxins are able to make meaningful contributions to the medical industry by making sure products are safe, while simultaneously generating profits and a return on investment.
Here are the key testing instruments you need to conduct these critical analyses. Note that cannabis analytical testing requirements may vary by state, so be sure to check the regulations applicable to the location of your laboratory.
The most important component of cannabis testing is the analysis of cannabinoid profiles, also known as potency. Cannabis plants naturally produce cannabinoids that determine the overall effect and strength of the cultivar, which is also referred to as the strain. There are many different cannabinoids that all have distinct medicinal effects. However, most states only require testing and reporting for the dry weight percentages of delta-9-tetrahydrocannabinol (Δ9-THC) and cannabidiol (CBD). It should be noted that delta-9-tetrahydrocannabinolic acid (Δ9-THCA) can be converted to THC through oxidation with heat or light.
For potency testing, traditional high-performance liquid chromatography (HPLC) is recommended and has become the gold standard for analyzing cannabinoid profiles. Look for a turnkey HPLC analyzer that delivers a comprehensive package that integrates instrument hardware, software, consumables and proven HPLC methods.
Heavy Metal Testing
Different types of metals can be found in soils and fertilizers, and as cannabis plants grow, they tend to draw in these metals from the soil. Heavy metals are a group of metals considered to be toxic, and the most common include lead, cadmium, arsenic and mercury. Most labs are required to test and confirm that samples are under the allowable toxic concentration limits for these four hazardous metals.
Heavy metal testing is performed by inductively coupled plasma mass spectrometry (ICP-MS). ICP-MS uses the different masses of each element to determine which elements are present within a sample and at what concentrations. Make sure to include accompanying software that provides assistant functions to simplify analysis by developing analytical methods and automatically diagnosing spectral interference. This will provide easy operation and analytical results with exceptionally high reliability.
To reduce running costs, look for a supporting hardware system that reduces the consumption of argon gas and electricity. For example, use a plasma ignition sequence that is optimized for lower-purity argon gas (i.e., 99.9% argon as opposed to more expensive 99.9999%).
The detection of pesticides in cannabis can be a challenge. There are many pesticides that are used in commercial cannabis grow operations to kill the pests that thrive on the plants and in greenhouses. These chemicals are toxic to humans, so confirming their absence from cannabis products is crucial. The number of pesticides that must be tested for varies from state to state, with Colorado requiring only 13 pesticides, whereas Oregon and California require 59 and 66 respectively. Canada has taken it a step further and must test for 96 pesticides, while AOAC International is developing methods for testing for 104 pesticides. The list of pesticides will continue to evolve as the industry evolves.
Testing for pesticides is one of the more problematic analyses, possibly resulting in the need for two different instruments depending on the state’s requirements. For a majority of pesticides, liquid chromatography mass spectrometry (LCMS) is acceptable and operates much like HPLC but utilizes a different detector and sample preparation.
Pesticides that do not ionize well in an LCMS source require the use of a gas chromatography mass spectrometry (GCMS) instrument. The principles of HPLC still apply – you inject a sample, separate it on a column and detect with a detector. However, in this case, a gas (typically helium) is used to carry the sample.
Look for a LC-MS/MS system or HPLC system with a triple quadrupole mass spectrometer that provides ultra-low detection limits, high sensitivity and efficient throughput. Advanced systems can analyze more than 200 pesticides in 12 minutes.
For GCMS analysis, consider an instrument that utilizes a triple quadrupole mass spectrometer to help maximize the capabilities of your laboratory. Select an instrument that is designed with enhanced functionality, analysis software, databases and a sample introduction system. Also include a headspace autosampler, which can also be used for terpene profiles and residual solvent testing.
Residual Solvent Testing
Residual solvents are chemicals left over from the process of extracting cannabinoids and terpenes from the cannabis plant. Common solvents for such extractions include ethanol, butane, propane and hexane. These solvents are evaporated to prepare high-concentration oils and waxes. However, it is sometimes necessary to use large quantities of solvent in order to increase extraction efficiency and to achieve higher levels of purity. Since these solvents are not safe for human consumption, most states require labs to verify that all traces of the substances have been removed.
Testing for residual solvents requires gas chromatography (GC). For this process, a small amount of extract is put into a vial and heated to mimic the natural evaporation process. The amount of solvent that is evaporated from the sample and into the air is referred to as the “headspace.” The headspace is then extracted with a syringe and placed in the injection port of the GC. This technique is called full-evaporated technique (FET) and utilizes the headspace autosampler for the GC.
Look for a GCMS instrument with a headspace autosampler, which can also be used for pesticide and terpene analysis.
Terpene Profile Testing
Terpenes are produced in the trichomes of the cannabis leaves, where THC is created, and are common constituents of the plant’s distinctive flavor and aroma. Terpenes also act as essential medicinal hydrocarbon building blocks, influencing the overall homeopathic and therapeutic effect of the product. The characterization of terpenes and their synergistic effect with cannabinoids are key for identifying the correct cannabis treatment plan for patients with pain, anxiety, epilepsy, depression, cancer and other illnesses. This test is not required by most states, but it is recommended.
The instrumentation that is used for analyzing terpene profiles is a GCMS with headspace autosampler with an appropriate spectral library. Since residual solvent testing is an analysis required by most states, all of the instrumentation required for terpene profiling will already be in your lab.
As with residual solvent testing, look for a GCMS instrument with a headspace autosampler (see above).
Microbe, Fungus and Mycotoxin Testing
Most states mandate that cannabis testing labs analyze samples for any fungal or microbial growth resulting from production or handling, as well as for mycotoxins, which are toxins produced by fungi. With the potential to become lethal, continuous exposure to mycotoxins can lead to a buildup of progressively worse allergic reactions.
LCMS should be used to qualify and identify strains of mycotoxins. However, determining the amount of microorganisms present is another challenge. That testing can be done using enzyme linked immunosorbent assay (ELISA), quantitative polymerase chain reaction (qPCR) or matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS), with each having their advantages and disadvantages.
For mycotoxin analysis, select a high-sensitivity LC-MS/MS instrument. In addition to standard LC, using an MS/MS selective detector enables labs to obtain limits of detection up to 1000 times greater than conventional LC-UV instruments.
For qPCR and its associated needs, look for a real-time PCR amplification system that combines thermal cyclers with optical reaction modules for singleplex and multiplex detection of fluorophores. These real-time PCR detection systems range from economical two-target detection to sophisticated five-target or more detection systems. The real-time detection platform should offer reliable gradient-enabled thermal cyclers for rapid assay optimization. Accompanying software built to work with the system simplifies plate setup, data collection, data analysis and data visualization of real-time PCR results.
Moisture Content and Water Activity Testing
Moisture content testing is required in some states. Moisture can be extremely detrimental to the quality of stored cannabis products. Dried cannabis typically has a moisture content of 5% to 12%. A moisture content above 12% in dried cannabis is prone to fungal growth (mold). As medical users may be immune deficient and vulnerable to the effects of mold, constant monitoring of moisture is needed. Below a 5% moisture content, the cannabis will turn to a dust-like texture.
The best way to analyze the moisture content of any product is using the thermogravimetric method with a moisture balance instrument. This process involves placing the sample of cannabis into the sample chamber and taking an initial reading. Then the moisture balance instrument heats up until all the moisture has been evaporated out of the sample. A final reading is then taken to determine the percent weight of moisture that was contained in the original sample.
Look for a moisture balance that offers intuitive operation and quick, accurate determination of moisture content. The pan should be spacious enough to allow large samples to be spread thinly. The halogen heater and reflector plate should combine to enable precise, uniform heating. Advanced features can include preset, modifiable measurement modes like automated ending, timed ending, rapid drying, slow drying and step drying.
Another method for preventing mold is monitoring water activity (aW). Very simply, moisture content is the total amount of water available, while water activity is the “free water” that could produce mold. Water activityranges from 0 to 1. Pure water would have an aW of 1.0. ASTM methods D8196-18 and D8297-18 are methods for monitoring water activity in dry cannabis flower. The aW range recommended for storage is 0.55 to 0.65. Some states recommend moisture content to be monitored, other states monitor water activity, and some states such as California recommend monitoring both.
As you can see, cannabis growers benefit tremendously from cannabis testing. Whether meeting state requirements or certifying a product, laboratory testing reduces growers’ risk and ensures delivery of a quality product. As medicinal and recreational cannabis markets continue to grow, analytical testing will ensure that consumers are receiving accurately
labeled products that are free from contamination. That’s why it is important to invest in the future of your cannabis testing lab by selecting the right analytical equipment at the start of your venture.
Cannabis businesses have become a driving force for economic growth in the United States. We’ve all heard the statistics. In 2018, the industry accounted for approximately $10.4 billion in revenue and is slated to grow to $21 billion by 2021.
But with growth comes pressure to produce more, enhance quality and optimize operations. However, managing a cannabis business without modern, capable tools can hinder growth and leave opportunities on the table. That’s why fast-growing cannabis businesses are looking to the proven benefits of a true cloud Enterprise Resource Planning (ERP) platform to help manage production, provide insights and improve business operations. When we add in the complexity and ever-changing nature of regulation, the need for a robust operational system becomes even more critical.
David Stephans will be speaking during CIJ’s October 9th webinar, “Driving Strategic Advantage for your Cannabusiness through Process Efficiency, Quality & Compliance” Click here to learn more and register for free.Cannabis business leaders may want to develop their own “playbook” to differentiate themselves in the market. But before they start to engineer their forward-thinking approach, they should start with a cloud ERP as their foundation. This can help with everything from the most basic of needs to more sophisticated strategies. In this article, we’ll review some key cannabis business goals and tactics, and how ERP can help lay the groundwork for success.
Drive growth and expansion.
Business growth often translates into operational expansion, meaning more facilities, staff and compliance requirements to manage. A cloud ERP supports these functions, including the launch of new products, expanding pricing schedules and increasing production to meet demand. Having the ability to track and manage growth is crucial, and a cloud ERP can provide the real-time reporting and dashboards for visibility across the entire business. This includes not just operational visibility, but also a look into a company’s sales, finances and supply chain.
Foster exemplary customer experience.
Cannabis companies need to streamline processes from the moment an order is placed to when it arrives at the customer’s door. In the mind of consumers, cannabis businesses compete against the likes of Amazon. They must be able to provide a similar experience and level of service, with customers receiving orders in a couple of business days. Cloud ERP can help automate processes. And when things go wrong, it can also help with resolution, especially when it’s paired with a customer relationship management (CRM) system on the same cloud platform. For the B2B market, cloud ERP empowers account management to review past orders to better meet future customer needs.
Stay a step ahead of the game.
In the industry, change is a constant. The future will likely bring about shifts in products, regulations and suppliers. A cloud ERP can modify workflows, controls and process approvals on the fly, so companies can adapt to new requirements. It offers security against emerging risks and easy integration with other systems cannabusinesses may need. An advanced cloud ERP will also provide cutting-edge capabilities, such as AI insights and data-capture from Internet-of-Things (IoT) devices.
Ensure quality product for raving fans and avoid flags on the field through airtight compliance.
Many cannabis companies are passionate about delivering the highest-quality cannabis products. Auditability is key to both quality and compliance. Complete traceability, with lot and serial number tracking, will record comprehensive audit trails from seed to sale. A cloud ERP will incorporate RFID tags down to the plant, lot and product levels to assist in this process. As cannabis goods move through their lifecycle, the cloud ERP will append appropriate tracking to purchasing receipts, inventory as it moves between locations, products as they’re packaged and sales orders as they’re fulfilled.
As a heavily regulated industry, cannabis business is also subject to burdensome compliance standards. A cloud ERP can support the rigorous testing that’s required to assure potency and safety. It easily facilitates Good Manufacturing Practices (GMP) and Good Production Practices (GPP), which ensures products are consistently produced according to quality standards. Many regulatory agencies require digital reporting; cloud ERP can facilitate this requirement through integration with Metrc, Health Canada and the FDA. Compliance can be a costly endeavor, and this type integration saves time, money, and effort.
As you can see, a cloud ERP helps efficiently balance compliance and regulatory requirements, with operational efficiency and customer service – key strategies in any cannabusiness playbook.
As the industry faces what is undoubtedly a watershed moment for the international cannabis vertical, a new Spanish firm steps into the market with its own EU GMP certification license. Linneo Health is also helmed by the ever eloquent and highly experienced Jose Antonio de la Puente – a tall drink of water with a conscience, a brain and an admirable mission statement.
This also implies, at minimum, government lack of coordination and agreement on EU GMP cert even between European nations, for a nascent industry while also trying to avoid the thorny issue of patient home grow. See also the trials and travails of the erstwhile German cultivation bid and its reconstituted Frankenstein-esque bigger if younger sister. In fact, this contretemps is almost certainly involved if not indirectly to blame.
Not All Is Entirely Rosy On Cannabis Europe’s Eastern Front
Almost simultaneously to Linneo Health’s announcement, however, the news came that in Poland, authorities had suspended the pending product registration process. Will this be on hold until after the October election?
In this environment it is almost impossible to know.
Here is one thing to consider. These almost simultaneous developments in Spain and Poland and the newest announcement about further certification of the Dutch recreational system under a new pending “recreational trial” are almost directly related.
That said, even such political maneuverings are not new – and far from limited to any single company. Both Germany and Poland have been wracked by reform stuttered by short term gain and market entry strategies executed by most of the biggest players in the room. Aurora, for example, announced their first import into Poland the same day the Polish government changed the law last fall. Aurora uses Germany as its breakpoint distribution center for Europe.
A Stamp of Authenticity That Is Sorely Needed
Beyond the pharma and market entry politics, however, this Alcaliber-helmed project creates a ring of authority to the same that creates at least one cannabis brand the European medical community can see the certification for.
For now at least, certainly among the ranks of the upper echelons of the international cannabis industry, there must surely be a sigh of relief.
EU GMP certifications (in other words, the authorization to produce product bound for a medical, pharma market) do not happen overnight. On the European front, this is surely at least a step in the right direction for an industry embattled by scandals, particularly of the securities, production, certification and accounting kind right now.
In this case, however, it is also clear that no matter the egregious oversteps and potentially illegal and certainly dubious behaviour of some members of the industry, there are also clearly those within it, and at high levels, who have tried to do the right thing. And further, from the beginning of the nascent industry here as of 2015.
Who Is Alcaliber?
Alcaliber is one of the world’s largest opioid manufacturers. Unlike American counterparts, the company decided several years ago to invest in and back ideas of the opioid-to-cannabinoid therapy model. Linneo Health is a 60% subsidiary of Alcaliber and 40% owned by a Spanish family office called Torreal, S.A.
This is, as a result, one of the most important GMP licenses in Europe at the moment if not the world. It means that within a pharmaceutical environment, the first widespread research and production of plants and therapies for those suffering from both chronic pain, plus neurological and oncological conditions that cause or are related to the same, will be put on a fast track long in the offing. Certainly in Europe.
And that for one, is a positive development that will have widespread implications elsewhere. Particularly given the news that the opioid epidemic in the United States finally has a name, and culpable parties.
What Else Is Unusual About This Project?
GMP certification is a vastly misunderstood concept at the moment. It is also a highly thorny one because of a still standardizing set of agreements. The regulatory environment is in place, in other words, but there are many, many gaps, as well as shifting rules and underlying treaties.
However, on top of this, there is also an amazing lack of innovation in interpretation, in part because of many misadvised consultants who are actually seeking to “save” production costs for their clients, or because they do not know any better. Or because producers are scared of doing the wrong thing.
The new project in Spain is unusual because it is a greenhouse grow that got EU GMP cert – although look for more of this in the future. It means that with careful, standardized, pharma production, not all regulated cannabis grows, even for the medical market, have to use huge amounts of energy in repurposed post-industrial developments. It is also certainly cleaner than growing outside. And, when done right, saves huge amounts of water.
Cleantech, in other words, has finally hit the cannabis industry in Europe. As well as a pharmaceutical company invested in the cannabinoid treatment of (at least) chronic pain.
That is an overdue and hugely positive development. No matter what else can be said for shenanigans engulfing the rest of the industry at the moment.
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