Tag Archives: Testing

By Amanda Rigdon

This is the first piece of a regular column that CIJ has been so kind to allow me to write for their publication. Some readers might recognize my name from The Practical Chemist column in this publication. Since the inception of that column, I’ve finally taken the plunge into the cannabis industry as chief technical officer of Emerald Scientific. Unlike The Practical Chemist, I will not spend the entire first article introducing the column. The concept is simple: while I find the textbook-esque content of The Practical Chemist scintillating, I have a feeling that the content is a little too heavy to spring on someone who is looking for engaging articles over their precious coffee break. Instead, The Nerd Perspective will consist of less-technical writing focusing on my experience and insights for the cannabis industry as a whole. But don’t worry – I’m sure I will not be able to refrain from technical jargon altogether.

To kick off the column, I want to talk about instrumentation for ‘instant’ cannabis potency testing. At this point, it’s common knowledge in the cannabis analytics industry that the most accurate way to test cannabis potency is through extraction then analysis by HPLC-UV. I agree wholeheartedly with that sentiment, but HPLC analyses have one drawback: they can be either inexpensive or fast – not both. There are some instruments entering the market now that– while not as directly quantitative as HPLC-UV – promise to solve the inexpensive/fast conundrum. During my most recent trip to California, I was able to spend some quality time with two well-known instrument manufacturers: SRI Instruments and PerkinElmer, both of whom manufacture instruments that perform fast, inexpensive cannabis potency analyses. From my previous home at the heights of The Ivory Tower of Chromatography: Home of the Application Chemists, SRI and PE couldn’t be more different. But as seen through the eyes of a company who deals with a wide range of customers and analytical needs, it turns out that SRI and PE are much the same – not only in their open and honest support of the cannabis industry, but also in terms of their love of all things technical.

My first stop was SRI Instruments. They are a relatively small company located in an unassuming building in Torrance, CA. Only a few people work in that location, and I spent my time with Hugh Goldsmith (chief executive officer) and Greg Benedict (tech service guru). I have worked with these guys for a few years now, and since the beginning, I have lovingly referred to them as the MacGyvers of chromatography. Anyone familiar with SRI GCs knows that what they lack in aesthetics, they make up for in practicality – these instruments truly reflect Hugh and Greg’s character (that’s meant as a compliment).

SRI specializes in relatively inexpensive portable and semi-portable instruments that are easy to set up, easy to operate, and most importantly – engineered for a purpose. It’s actually really hard to manufacture an instrument that meets all three of these criteria, and the folks at SRI accomplish this with their passionate and unique approach to problem solving. What I love about these guys is that for them, nothing is impossible. Here’s an example: the price of the portable GC-FID instruments SRI builds is inflated because the instruments require separate – and pricey – hydrogen generators. That’s a big problem – hydrogen generators are all pretty much the same, and none of them are cheap. This didn’t faze SRI: they just decided to design their own super small on-board hydrogen generator capable of supplying hydrogen to a simple GC system for six hours with just 20mL of distilled water from the grocery store! I’m not kidding – I saw it in action on their new Model 420 GC (more on that in some future pieces). Was the final product pretty? Not in the least. Did it work? Absolutely. This kind of MacGyver-esque problem solving can only be done successfully with a deep understanding of the core principles behind the problem. What’s more, in order to engineer instruments like these, SRI has to have mastery over the core principles of not only chromatographic separation, but also of software development, electrical engineering, and mechanical engineering – just to name a few. These quirky, unassuming guys are smart. SRI is a company that’s been unapologetically true to themselves for decades; they’ll never be a contender for beauty queen, but they get the job done.

On the surface, PerkinElmer (PE) contrasts with SRI in almost every way possible. With revenue measured in billions of dollars and employees numbering in the thousands, PE is a behemoth that plays not only in the analytical chemistry industry but also in clinical diagnostics and other large industries. Where SRI instruments have a characteristic look of familiar homeliness, PE instruments are sleek and sexy. However, PerkinElmer and SRI are more alike than it would seem; just like the no-frills SRI, the hyper-technical PE instruments are engineered for a purpose by teams of very smart, passionate people.

With its modest price tag and manual sample introduction, the SRI Model 420 is engineered for lower throughput users to be a fast, simple, and inexpensive approach to semi-quantitative process control. The purpose of the instruments manufactured by PE is to produce the highest-quality quantitative results as quickly as possible for high-throughput labs. PE instruments are built using the best technology available in order to eke out every last ounce of quantitative accuracy and throughput possible. Fancy technology is rarely inexpensive, and neither is rigorous product development that can last years in some cases. In a way, PE is Doogie Howser to SRI’s MacGyver. Like MacGyver, Doogie is super smart, and his setting is a sterile hospital rather than a warzone.

I had a wonderful conversation with Tim Ruppel, PE’s headspace-GC specialist, on the sample introduction technology incorporated into the TurboMatrix Headspace Sampler, where I also learned that the basic technology for all PerkinElmer headspace-GC instruments was designed by the men who wrote The Book on headspace gas chromatography: Bruno Kolb and Leslie Ettre**. Later, I was able to get a much-needed lesson on FT-IR and the Spectrum Two IR Spectrometer from Brian Smith, PE’s spectroscopy expert, who actually wrote the book on quantitative spectroscopy***. Tim and Brian’s excitement over their technology mirrored that of Hugh and Greg. It turns out that SRI and PerkinElmer are more alike than I thought.

These two instrument manufacturers have addressed the fast/inexpensive conundrum of cannabis potency testing in two different ways: SRI’s instrument is extremely inexpensive, easy to operate, and will provide semi-quantitative values for THC, CBD, and CBN in just a few minutes; PE’s instrument is more expensive up front, but provides quantitative (though not directly quantitative) values for all of the major cannabinoids almost instantly, and requires almost no maintenance or consumables. These two instruments were designed for specific uses: one for inexpensive, easy use, and the other for more comprehensive results with a higher initial investment. The question consumers have to ask themselves is “Who do I need to solve my problem?” For some, the answer will be MacGyver, and for others, Doogie Howser will provide the solution – after all, both are heroes.

** B. Kolb, L. Ettre, Static Headspace-Gas Chromatography: Theory and Practice, John Wiley & Sons, Hoboken, NJ, 2006.

*** Brian C. Smith, Quantitative Spectroscopy: Theory and Practice, Elsevier, Boston, MA, 2002.

September 6, 2016

Quality From Canada

The Devil is in the Detail – Changes to Canada’s Cannabis Regs to Encourage Patient Independence and Business Competition

By Tegan Adams, Elfi Daniel-Ivad MSc

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Canada’s new ACMPR was launched late last month on August 24^th. The key change that most notice is that Canadians may now again grow their own cannabis at home for medical purposes. In addition, more strict guidelines for product testing and labeling requirements for Licensed Producers (LPs) were released.

Short term pain for long term gain. While the combination of allowing patients to grow at home and more strict regulations for LPs may at first seem like a business disadvantage; overtime LPs will be thankful for the combination switch. Health Canada’s new requirements encourage a leveling of the playing field globally between LPs and large scale product manufacturers of pharmaceuticals, therapeutics and natural health products. The steps Health Canada is taking to regulate our producers, is exactly what they need to get ready for mass production that will be necessary for recreational markets, scheduled for release in Spring 2017.

Picture rows of Tylenol bottles on the shelf at your favorite pharmacy. Now picture rows of cannabis bottles on the shelf beside them. This is what medical cannabis will look like in Canada perhaps as early as 2018, if not sooner. With just under forty LPs on the map and a projected sales volume of modest billions, Canada’s LPs’ eyes are widening with dollar signs as they lube up their oil production and more to see what shelves in Canada will hold.

Curious to know more? Our regulatory department manager Elfi Daniel-Ivad is an expert in regulatory change. She has worked on close to 150 submissions for cannabis licensees in Canada and beyond. Here are a few key changes from her department’s overview to better understand.

MMPR	ACMPR (Updated)
No personal production or designated production available to patients (aside from that grandfathered in by MMAR).	Personal production and designated production available. Patients may grow 5 indoor plants OR 2 outdoor plants at any given time per gram prescribed to them.
Licensed Producers were not required to label THC or CBD amounts in dried cannabis, though most producers did for sales and educational purposes. Oils had to be labeled with THC and CBD amounts.	Licensed Producers must label their percent THC and CBD for dried and fresh cannabis products.
For the labelling of oils, the total quantity of THC, CBD and oil in a container had to be shown. Restrictions on THC allowed no more than 10mg/mL THC per capsule and no more than 30mg/mL THC per mL oil to be distributed.	In addition, oil labels must now include information on “carrier” oil and allergen information. Containers must be labelled with number of capsules, the net weight and volume of each capsule. .
No reference to validation of analytical testing methods.	Analytical testing must be completed using validated testing methods; confirming reliability and consistency in results for contaminants, disintegration, residues and THC, THC-A, CBD and CBD-A
Accredited labs can only test products as received from Licensed Producers.	In addition to Licensed Producers, patients growing their own or having a designated grower growing for them may also test their products at an accredited lab.

In addition to these changes, it is important to note that if an individual or company has an MMPR proposal already submitted they can now revise it to include oil production (previously, it was first dried bud only). If a company submits a new ACMPR proposal, they can include oil production on their application right away. Interested in submitting your own application? Or need help with one in the USA? Our regulatory department would be happy to answer any questions you might have about the process.

August 22, 2016

Hemp-Derived CBD Oil: Maintaining Quality in the Manufacturing Process

By Aaron G. Biros

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Hemp-derived cannabidiol (CBD) products are quickly becoming a burgeoning industry. Consumers can purchase the products in all fifty states and can receive the therapeutic effects of certain cannabinoids without any psychoactivity. Commonly used to help treat inflammation, pain, seizures and anxiety, CBD comprises a sizable portion of the cannabis market that patients and consumers are flocking to.

Founded by Paul Benhaim in 2013, Colorado-based Elixinol is reaching this market with a line of hemp-derived CBD oils and capsules. The company has grown rapidly and now has agreements with exclusive distributors in Japan, Puerto Rico, The United Kingdom and South Africa.

According to Chris Husong, sales and marketing director at Elixinol, achieving superior quality is central to the company’s growth strategy. “We are thinking about the long-term play here,” says Husong. Achieving the highest quality possible starts with sourcing from industrial hemp farms in Northern Europe, according to Husong. Through good manufacturing practices (GMPs), the company pays close attention to every detail involved in producing the hemp-derived CBD oil.

Safety and transparency are two core tenants in the company’s goal to strive for quality products. “We use third-party independent labs for our testing including one in Northern Europe where we source from in addition to Proverde Labs when it reaches us in Colorado,” says Husong. They test their products for over 300 chemicals (including pesticides, residual solvents and heavy metals) as well as for microbiological contamination and a unique terpene profile using GC-MS/GC-FID.

Co-founder Paul Benhaim at their extraction and testing facility in Europe.

In addition to stringent manufacturing safety procedures and testing, tracking is a huge part of meeting quality standards. Each product batch also has a lot number. While batch numbers are a requirement in GMPs, lot numbers mean that they are well equipped in the event of a product recall. After the product is packaged, they perform additional spot-checks periodically.

Contract manufacturing and white-labeling products is a large part of their business, so the company needs to meet rigorous quality standards for their partners as well. “We provide our oil to a variety of associates, but we are always looking for new partners on the cutting edge, innovating with new products that we can help with,” says Husong. Very often, this means doing a full plant extraction for different uses. Utilizing a full-spectrum plant extraction helps maintain a well-balanced cannabinoid profile with many of the original terpenes found in the plant.

Japan's first lady, Akie Abe, purchasing Elixinol's hemp-derived CBD oil. — Akie Abe, first lady of Japan, purchasing Elixinol’s hemp-derived CBD oil.

What makes their product so appealing to consumers is not just the quality, but also the method of delivery into the bloodstream and very precise dosing. “Our liposome products have a relatively new technology that allows the oil to be absorbed into your system via fatty acids, which lets you absorb the compounds much faster, requiring less of it and more consistency,” adds Husong. In addition to their fast-acting delivery mechanism, they produce capsules dosed to precisely fifteen milligrams and a delivery system they call ‘Xpen,’ which draws the oil in an oral applicator to a precise dose of fifteen milligrams every time.

After the manufacturing process, the company pays close attention to detail in their packaging and distribution. “The packaging is built to maintain that quality in the manufacturing process and to extend the shelf life of our products,” says Husong. The technology that goes into their packaging involves using Miron Violet glass, which is anti-fungal and prevents external light from deteriorating the oil inside.

This growing sector in the cannabis market is representative of a greater trend: the commodification of hemp and cannabis. When businesses like Elixinol scale up production of goods such as CBD oil, a lens focused on consistency and quality can not only improve business operations but also raise the standard across the entire industry.

August 15, 2016

A2LA Accredits TEQ Analytical Laboratories

By Aaron G. Biros

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The American Association for Laboratory Accreditation (A2LA) recently announced the accreditation of TEQ Analytical Laboratories, based in Aurora, Colorado. The laboratory is now accredited to ISO 17025:2005, the first recreational cannabis-testing lab to do so in North America.

“By achieving ISO/IEC 17025 accreditation, TEQ Analytical Labs believes that we can address the concerns throughout the cannabis industry regarding insufficient and unreliable scientific analysis by providing our clients with state-required tests that are accredited by an international standard,” says Seth Wong, president of TEQ Analytical Laboratories. According to a TEQ Analytical press release, accreditation to this standard confirms that laboratories have the management, quality, and technical systems in place to ensure accurate and reliable analyses, as well as proper administrative processes to confirm that all aspects related to the sample, analysis and reporting are standardized, measured and monitored.

By implementing ISO 17025 accreditation, the laboratory monitors systems and processes central to analyses in an effort to minimize discrepancies and variability in test results. According to Roger Brauninger, biosafety program manager at A2LA, this type of accreditation demonstrates their competence and commitment to rigorous science. “It is encouraging to have testing laboratories taking ownership of the quality of the work performed,” says Brauninger. “Reliable testing will be imperative to insure safety of the products out on the market as this industry continues to expand.” As the first accreditation of its kind in North America, Brauninger hopes this will open the doors for more cannabis laboratories to acknowledge their role in demonstrating scientific competency for the industry.

Tripp Keber, president and chief executive officer of Dixie Brands, Inc., commends the achievement. “At Dixie Brands, we believe that cannabis is powerful, that quality is important, and that accurate dosing is of supreme importance,” says Keber. “Because Dixie is committed to delivering a safe, consistent, and accurately dosed product, lab testing is a vital component to our manufacturing processes.”

“TEQ’s achievement of ISO 17025 accreditation instills great confidence to Dixie Brands that our consumers’ health and safety is ensured and that they will enjoy a reliable and predictable experience with our product each and every time,” adds Keber. “Dixie’s strategic relationship with TEQ continues to build long-term brand value.” This kind of accreditation helps build trust in laboratories’ clients knowing they can provide accurate results repeatedly.

July 12, 2016

Quality From Canada

Cannabis in Canada: 6 Key Considerations for Recreational Legal Distribution

By Tegan Adams

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Canada has been undergoing many changes in the cannabis marketplace, most notably in the last two years. Originally, the system began with increasing access to cannabis for those with medical conditions under a “grow your own” model, the Medical Marihuana Access Regulations (MMAR). After running for a while, our regulatory authority, Health Canada, decided that among other faults, the MMAR program could pose a security risk to individuals growing at home. Following the dissolve of the MMAR, later released was a set of regulations, called Marihuana for Medical Purposes Regulations (MMPR) to license commercial producers now called Licenced Producers (LPs). While some MMAR patients were grandfathered in, the MMPR began as the mainstream cannabis production platform. MMPR LPs are inspected with high security and quality standards to produce and distribute cannabis exclusively to medical patients with a doctor-prescribed medical document. Patients register with one LP exclusively and receive cannabis by a mail-order system, and mail order only.

Why mail order with a medical document? What about all the dispensaries selling cannabis across Vancouver and Toronto? Where is all this cannabis coming from, if the MMPR LPs can only distribute direct to a patient through mail order?

These are good questions. And they are questions you should be asking. There are a few different factors contributing to the vast array of consumer confusion across borders in the Canadian system. People are passionate about cannabis, as well as their own personal freedom to have it. Some are passionate for medical reasons, others for the pure punch of liberation. Either way these passions have resulted in an interesting series of court decisions including a more recent one that deemed the MMPR unsuitable to provide enough access to cannabis for those in need. Effective close to the end of August this year in 2016, the MMPR as it is currently written will cease to be in effect and require revisions or a new system entirely for the legislation to be accepted and continued with.

There are a few different critiques of the MMPR which include: not enough variety, no ability to “see and feel” products before purchase, limitations on supply sources, limitations on dosage formats (i.e. oil and dried flowers only) and some might try to argue the rise in cost. While cannabis remains illegal to traffic without adequate controls across Canada, it is low on the priority list for the RCMP to spend resources on. Depending on which town and situation you are caught carrying it in, you would be hard pressed to be charged for carrying cannabis unless you ask for it. So, Canada has seen a surge in retail dispensaries, licensed or not, at the municipal level to the point where hundreds of them now exist across the country, distributing hundreds of millions of dollars of cannabis products per year.

Dispensaries vary in degree of professionalism, prices and strains available. Some have over sixty strains while others hold only four or five. Because Health Canada does not require laboratory testing of these products, most do not know their cannabis’ potency or that it is safe from bacteria, moulds, pesticides and aflatoxins. If they wanted to know, they could not find out since those with Narcotics Licences for testing are unable to accept their products under any regulatory framework.

We have seen false and unaccredited labs pop up on street corners accepting the unregulated products, but what we have not seen is information on the methods these labs are using, how they are validated and whether or not they are accurate. Regardless, the general consumer base does not seem to mind. Many of these locations have been reportedly selling $20,000-$30,000 CAD per day per 5,000 square feet or less of an operation. That is on average $600,000 per month and if continued for a full year as some have done, around $7.2M per year. All unregulated, and all up until recently tolerated by our RCMP and local policy authorities.

Finally, given the industrial-scale distribution that was not just occurring in the black market anymore, different neighbourhoods that did not like cannabis complained. LPs complained. And other regulated product industry members complained. They all complained that the unregulated distribution of cannabis was negatively affecting them in one way or another. And so, Canada saw raids. Hundreds of dispensaries raided, and many people were arrested if only temporarily. Products were seized. However, these raids generally proved ineffective and we saw most of these dispensaries open the next day. While the daily amounts seized might have sounded like a lot, they were only about one day’s sales for most of these locations, providing the authorities with a better glimpse into just how much diversion of the supposedly controlled substance was going on.

Given that cannabis is promised for recreational legalization in the spring of 2017 in Canada, many are wondering about what sort of business opportunities there might be on the horizon. We know that while control of production will probably remain similar to how it is now, our distribution models will change. Here are a few points Health Canada is considering in their latest discussions:

A phased-in approach to distribution will probably be necessary. First, continuing with the mail-order system would be the easiest phase in approach.
Regulated storefronts as an alternative to the current dispensaries. It is doubtful that dispensaries operating as they are will continue. There are rumors floating around that Shopper’s Drug Mart and other pharmacies will be able to help with distribution. Time will tell if these rumors evolve.
Provincial and Territorial uniqueness. Distribution could be altered at regional levels and different models could be developed across the country, similar to liquor regulations in effect. Some of our provincial liquor distribution entities have inquired to become distributors.
Keep cannabis away from minors. Health Canada is considering a look at locations, hours of operation, density of retailers and producers and consumption of cannabis outside of personal dwellings all as factors in the new system.
Guarding against impaired driving. Our regulators want to make sure they have enough tools to monitor those who may have been driving after consumption of cannabis.
Sound product packaging and labeling. A focus on understanding THC & CBD potencies as well as appropriate health warning messages. Packaging and Labeling, and effectively sound testing, will all be necessary.

Want to know more, or see for yourself? Check out Health Canada’s latest discussion document.

Curious to know what this will mean for packaging and labeling? Get in touch with me to better understand what Eurofins-Experchem currently tests for with our Licensed Producers. Contact me at 416 665 2134 ext 252 or teganadams@eurofins.com

June 28, 2016

The Emerald Test Yields Positive Results for Cannabis Labs

By Aaron G. Biros

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Emerald Scientific recently announced results for their latest round of the semi-annual Inter-Laboratory Comparison and Proficiency Test (ILC/PT), and the outcomes may bode well for one of the most vital quality and safety aspects of the cannabis industry. According to Cynthia Ludwig, director of technical services at the American Oil Chemists’ Society (AOCS), there are no official methods for cannabis testing from an internationally recognized non-profit organization known to provide ‘official methods’ to various industries, so method validation needs to be done in-house, which is very costly and time-consuming. Cannabis testing labs are charged with the difficult task of providing honest, consistent and accurate results for potency, pesticide residue, residual solvents and contaminants. AOCS partnered with Emerald Scientific in this round of ILC/PT and preformed the statistical analysis and reports. For the first time in The Emerald Test’s history, participants were able to review all of the raw data and were given a consensus mean, z-scores and kernel density plots in order to compare themselves to other participants.

Emerald Scientific’s ILC/PT program measures how accurately a cannabis lab performs along with comparing it to other labs for an indicator of variability and ways to improve, according to a press release. 46 cannabis laboratories participated in The Emerald Test’s latest round of proficiency testing for potency and residual solvents. Cynthia Ludwig sits on the advisory panel to give direction and industry insights, addressing specific needs for cannabis laboratories. Kirsten Blake, director of sales at Emerald Scientific, believes that proficiency testing is the first step in bringing consistency to cannabis analytics. “The goal is to create some level of industry standards for testing,” says Blake. Participants in the program are given data sets, judged by a consensus mean, so labs can see their score compared to the rest of the cannabis testing industry.

Proficiency tests like The Emerald Test give labs the ability to view how consistent their results are compared to the industry’s results overall. According to Ludwig, the results were pleasantly surprising. “The results were better than expected across the board; the vast majority of labs were within the acceptable range,” says Ludwig. The test is anonymous so individual labs can participate freely. “The overall performance of the participating labs in the Potency and Solvent Residue Emerald Test were very encouraging,” says Ludwig. “All but a couple of labs had the majority of their results fall within two standard deviations of the consensus mean, which is generally accepted as being within the acceptable limits to most evaluators.” Although requirements for labs testing cannabis differ in each state, Ludwig says the results show the ability of these labs to competently perform the tests and generate reliable results. “Given the lack of harmonized regulations, this is a testament to the self-imposed quality standards the industry is trying to achieve.”

Reggie Gaudino, Ph.D., vice president of scientific operations and director of genetics at Steep Hill Laboratories. (photo credit: Preston Gannaway)

Among the laboratories that participated, Steep Hill Laboratories joined the test at two of their locations. Reggie Gaudino, Ph.D., vice president of scientific operations and director of genetics at Steep Hill Laboratories, believes that tests like the Emerald Test ensure that the cannabis labs are performing their function to the best of their ability, which is extraordinarily important. “We, and not just Steep Hill, but all testing labs, are the custodians of quality and safety for the cannabis industry,” says Gaudino. “If we are not doing our best to ensure the quality of our science is beyond reproach, then we are failing the consumer; if even one person gets sick or dies because a lab cut corners and tried to make extra money, that is one person too many.” Accurate testing comes from internal and external proficiency testing.

According to Gaudino, how cannabis labs perform in The Emerald Test can affect every aspect of cannabis consumption: “Correct dosing from potency analysis reports, identification of as many, if not all, active compounds known to enable the consumer to make a determination as to which strain, edible or concentrate would be most beneficial and assurance that there are no harmful chemicals or biological contaminants on cannabis or cannabis derivatives; all of it stems from being able to accurately test.” Gaudino is a major proponent of The Emerald Test because it provides some measure of consistency and accuracy in the cannabis industry. Until more consistent regulations for cannabis testing are formed on a national scale, self-imposed quality standards such as The Emerald Test helps labs, growers and consumers know they are getting reliable data.

May 24, 2016

Terra Tech Expands, Maintains Quality: A Q&A with CEO Derek Peterson

By Aaron G. Biros

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Terra Tech, with the recent acquisition of Blum, a dispensary in Oakland, and the line of concentrates, IVXX, is sweeping the cannabis industry by setting standards for safety and quality. Terra Tech, publicly traded in the Over-The-Counter market, is well known as an agricultural company, with the subsidiary brand, Edible Garden, selling produce to Whole Foods, Wal-Mart and Kroger’s. In December of last year, we covered Terra Tech’s entrance into the cannabis marketplace and their experience with large-scale, sustainable agriculture. We sit down with Derek Peterson, chief executive officer of Terra Tech, to get an update on their progress and quality controls.

CannabisIndustryJournal: In January, Terra Tech announced revenue guidance of $20-22 million for 2016. Can you share some of your strategy going forward to meet your goals?

rsz_img_2343 — Terra Tech is taking organic and GFSI-certified agricultural practices to growing cannabis

Derek Peterson: We have always played both a long game as well as a short game, meaning while we are building our longer term business, like in Nevada, we are also focusing on short term accretive acquisitions, like we did with Blum in Oakland. We want to make sure we capture short-term revenue growth while we plan our future revenue production. We feel confident about achieving those results.

CIJ: How big of a role does the acquisition of Blum and IVXX brand expansion play in meeting those goals?

Blumoakland — The Oakland location of Blum dispensary

Derek: Blum is a significant factor even though we are only capturing three quarters of revenue considering we closed the deal on March 31^st of this year. So for the full year of 2017 we will have growth from this level considering we will be able to report a full year of Blum revenue. IVXX presents us with the best opportunity for growth in the coming years. As the market in California and Nevada grows we can continue to expand our IVXX footprint throughout the state. Being able to wholesale to thousands of other retail facilities affords us a significant opportunity to grow our sales.

CIJ: How do you think the brand of Edible Garden positions you well for expansion in the cannabis industry?

Poinsettias ready for distribution at Edible Garden facility in Belvidere, New Jersey — Produce ready for distribution at Edible Garden facility in Belvidere, New Jersey

Derek: One of the reasons we were so successful in the Nevada market was because regulators and legislators felt a high degree of confidence in our abilities considering we are USDA organic, Kosher and GFSI-certified. Our traditional agricultural experience has been very synergistic with our cannabis division from both an optics and operational perspective.

CIJ: Could you give us an update on progress in Medifarm LLC in Nevada? And on your distribution plan for IVXX in California?

Derek: We are continuing to expand our IVXX line throughout the state and increasing our sales force. In addition we will continue to develop new products to distribute into our existing supply chain, like we just did with our new pre filled cartridge line.

We are opening our Decatur location in Las Vegas in early July and Reno and Desert Inn towards the end of August. Our cultivation and extraction facilities should be complete no later than January 2017. We will have our entire infrastructure in place if the recreational bill passes in Nevada this November.

Blum Las Vegas location will open in July

CIJ: Tell us about the role of laboratory testing in your business.

Derek: Laboratories play a significant role, as they are becoming a mandated step in most new legislation around the company. Independent lab testing is extremely important to maintain safe access for consumers and patients. We work primarily with Steep Hill Labs and CW analytics.

CIJ: Can you expand on your integrated pest management and your growing practices?

stickerscannabis — Platinum Cookies ready for packaging and labelling

Derek: Well we cannot say organic, however we do cultivate all naturally. We also cultivate traditional produce that we sell to major retailers. We are USDA organic-certified and we implement similar processes in our cannabis cultivation. Pest control is extremely challenging for any farmer but we rely primarily on bio control, meaning the good bugs eat the bad bugs. This has been very effective for us in the cultivation of all our products.

CIJ: How is your business different from the slew of other dispensaries and growers in California?

Consistency in quality standards requires meticulous SOPs

Derek: Service and consistency; we have over 42,000 registered patients and our operations team has over 19 years of experience in California. One of the reasons we have become one of the largest dispensaries in the state is because of that experience. In addition, consistency is extremely important. Consumers expect the same product in every other business and ours is no different. If they come in for our Platinum Cookies one month and the next month it has different characteristics you are going to lose patient confidence. So in the front of the house, we are focused on pairing patients’ needs with the correct product and in the back of the house we are focused on providing a meticulously cultivated product, produced at the highest standards.

CIJ: Can you delve into some of the processing for concentrates? How do you meet such rigorous quality standards?

IVXX processing — Extraction equipment in one of the processing facilities for IVXX

Derek: Through research and development, we have engineered a proprietary process in which our solvent profiles used under our proprietary conditions ensures solvent residual levels which are not detected by instrumentation at 3^rd party testing agencies such as Steep Hill Labs. In addition, any good scientific method requires repetition and corroboration of results. In order to accomplish this we also rely on random routine testing in which we send out extracts out to other 3rd party testing labs. Proprietary conditions include, but are not limited to, heat, vacuum, agitation, etc. By utilizing the correct amalgamation of solvent profiles, extraction conditions, purging conditions, as well as rigorous quality control standards, we are able to ensure a product that is void of any residual solvents, without sacrificing potency or identity of the cannabinoids and terpenes. Cannabinoids and terpenes are of chief interest when extracting cannabis for patients so that they have access to these essential oils without any of the actual leaf and bud.

All solvents used are the highest grade available to us, which ensures a truly medical product for the patient. In addition, all of our extraction equipment is routinely cleaned and sterilized using medical grade cleaning agents.

March 23, 2016

Quality From Canada

Quality Training in a GMP Testing Facility: 8 Steps to Get Employees Compliant

By Tegan Adams

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Eurofins-Experchem Laboratories is a Health Canada and FDA-accredited analytical laboratory with a regulatory support division. The laboratory carries out testing for many different sectors including pharmaceuticals, cosmetics, natural health products and medical devices. Starting in 2014, cannabis testing was incorporated into the mix. One reason our results so accurate is due to rigorous staff orientation and training method. Diligent staff training and monitoring is very important for success as a Good Manufacturing Practices (GMP) facility with a Drug Establishment Licence and Narcotics License. So what does that look like on the inside? Saif Al-Dujaili, our quality assurance manager, Sohil Mana, our vice president of operations, and I will provide some guidelines for developing training programs below.

Introductory Session: When any new employee starts an introductory phase, it begins with general admin, a facility tour, policy manual training, govt. legislation overview and health and safety training and orientation (WHIMS and Bill 168) specific to our lab. We record signatures on any pertinent forms for SOPs that the new employee will be using.
Standard Operating Procedures: Any new employee must read all related SOPs and is evaluated on their understanding of them through questionnaires/quizzes. SOPs are written for all equipment, instrumentation or process that is applied in the lab, to ensure consistency across operations.
Laws and Regulations: New employees must be familiar or familiarized with Good Manufacturing Practices and Good Laboratory Practices. Analysts are required to read all sections of the USP pertinent to their role, as decided by the quality manager and/or dept. head and a checklist is recorded on training.
Methods: Different methods are used to test products including Compendium or other published methods with organizations such as the Association of Analytical Communities (AOAC) and the American Chemical Society (ACS). Client Methods and house-developed methods are also used. If there is a change to any method, a change control form must be filled out and documented.
Documentation: Documentation is very important in a GMP lab. All data is recorded in a hard cover bound book and/or approved worksheets. Quality assurance data reviewers are responsible for ensuring all data is being recorded properly.
Sample Management: Employees are trained on sample management related to sample entry, how samples are distributed to analysts, turn-around time, and where finished projects are placed.
Training Forms: Everything an employee learns must be recorded and filed for records. Analysts must follow a training matrix on qualitative and quantitative testing methods. Recurrent training occurs each 3 years or less depending on the position the analyst holds. Any updates on GMPs, new instruments or equipment is ongoing and recorded. Experchem runs “ghost” samples through its laboratory to ensure compliance by employees at any given time. Employees are evaluated on their abilities to comply.
Ongoing Training: Once employees are up and running they also receive monthly training in the lab and an annual GMP training followed by a comprehensive quiz that must be passed for them to continue work.

Interested in learning more about cannabis testing in Canada and the US? Contact Tegan Adams, business development manager with Eurofins at teganadams@eurofins.com.

Editor’s Note: Eurofins-Experchem has helped submit over 150 MMPR applications to Health Canada and continues to work with 10 of the 27 licensed MMPR producers in Canada. Their regulatory affairs division has started working with companies applying to produce and distribute cannabis in those states, which are new to its sale and distribution. They offer services include writing SOPs, training staff and performing mock inspection audits.

March 18, 2016

Cannabis Labs Conference Makes History at Pittcon

By Aaron G. Biros

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Last week’s Pittcon, the world’s leading conference and expo for laboratory science, brought together thousands of laboratory equipment companies, scientists and laboratory professionals in Atlanta. This year’s meeting made history, as it featured Pittcon’s first cannabis conference.

Generating quite a bit of buzz at the show in Atlanta, the inaugural Cannabis Labs Conference brought Pittcon attendees, cannabis industry leaders and scientists together to discuss the changing landscape of cannabis testing, the need for standards and cannabis laboratory methods. The improvement of quality standards, outside industry expertise and noting the industry still has a long way to go were some of the themes that came out of the talks.

Nic Easley, chief executive officer of Comprehensive Cannabis Consulting (3C), delivered the keynote, addressing concerns over consumer safety and lab testing standards in such a fast-paced market. “What we need now are outside industry experts to help guide this industry with standards and proper analytics,” he said. “With increased efficiencies and competition in the cannabis marketplace, our ethics need to be called into question as the industry reaps its profits.”

Other highlights included the sharing of new validation methods. Scott Radcliffe, technical support scientist at Romer Labs, Inc., presented his findings on the validation of immunoassays for the detection of pathogens and mycotoxins in cannabis. Amanda Rigdon, applications chemist at Restek, Inc., also led a discussion on the opportunities and challenges for method validation in the evolving cannabis industry.

Rigdon provided a glimpse into the amount of work it takes for method validation. “You can have all of the regulations in the world but that does not guarantee that you will produce good data,” Rigdon said. “We need good science, which is lacking currently in the industry.”

rigdoncannabislabs — Amanda Rigdon, applications chemist at Restek, leading a talk on method validation

“We need to show proficiency with a standardized method and that comes through full validation which, requires a lot of money, time and work,” Rigdon added. These components of validation include accuracy, precision, recovery, selectivity, specificity and proper instrument calibration. “The bottom line is labs need a method that is reproducible and robust,” she said. Rigdon also shared her data from recent methods validation at a cannabis laboratory in Spokane, Washington.

Next year’s Cannabis Labs Conference is scheduled to take place in Chicago during the week of March 5, 2017. To hear more about the Cannabis Labs Conference, sign up for the CannabisIndustryJournal newsletter.

March 16, 2016

New Cannabis Lab Rules In Oregon Aim to Curb Fraud

By Aaron G. Biros

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The Oregon Health Authority (OHA) recently implemented a set of temporary rules effective through June 28^th of this year with the goal to establish a set of regulations for cannabis testing by October 1^st. An investigation by The Oregonian highlighted some of the previous problems with cannabis testing in the state.

The most impactful rule changes include The NELAC Institute (TNI) mandatory standards for laboratories that the Oregon Environmental Laboratory Accreditation Program (ORELAP) will use to accredit labs. Initial rules in the Oregon medical cannabis program, HB 3460 from 2013, did not specify accreditation rules for cannabis testing.

oganalyticalworkstation — The OG Analytical laboratory in Eugene, Oregon is working to comply with new regulations, including new sample collection rules

ORELAP currently performs accreditation for lab testing under the Clean Air Act, Clean Water Act, Resource Conservation and Recovery Act and the Safe Drinking Water Act. The new cannabis testing rules will give ORELAP the authority to accredit and regulate cannabis labs in the state of Oregon.

Rodger Voelker, Ph.D., laboratory director of OG Analytical in Eugene, OR, believes these rules are monumental in establishing legitimacy in cannabis testing. “These new rules have major repercussions mainly because they require not only getting accreditation, but maintaining it with very strict requirements,” says Voelker. “That also includes procedural guidelines that very carefully outline the quality of laboratory practices and establishes a set of criteria for method validation.”

Roger Voelker — Rodger Voelker, lab director at OG Analytical laboratory

Voelker notes that two of the biggest changes are in quality control and data management. “The documentation they require is very thorough and strict with the idea that any aspect of an analysis can be replicated,” adds Voelker. “This is a real win for us in my opinion because now we have an agency that can issue the appropriate credentials as well as have the authority to make punitive measures.”

The timeline for implementation with temporary rules allows state regulators to work with laboratories to perform accreditation and bring laboratories up to speed. According to Shannon Swantek, ORELAP compliance specialist, products that dispensaries sell in medical and recreational markets are required to be tested under the new rules and in the analyte lists by an ORELAP accredited laboratory, starting on October 1^st.

Swantek’s job is to accredit cannabis labs to the TNI standards, which is essentially very similar to ISO 17025, just with more prescriptive measures and the ability to pair with state agencies to enforce rules after accreditation. “The timeline for accreditation is dependent on how ready the lab is and how compliant they are to the TNI standard already,” says Swantek. “The culture had gotten so fraudulent that the legislature felt Oregon needed some serious, more strict rules in place.”

One of the biggest changes coming to Oregon cannabis testing is the new sampling requirement. “An accredited laboratory employee must take the sample because sampling is where a lack of training or outright fraud is skewing results, which occurs when a grower brings in a sample not representative of the batch,” adds Swantek. Sample preparation methods will also be required to be more robust to meet the action limits of pesticide testing in particular, helping to identify lower levels like parts-per-billion, according to Swantek.

Reports were also lacking key information in the past. The new rules will require more information such as the procedure used, the analyst carrying it out, dilution factors and any other information you need to theoretically reproduce the result. This will result in more accurate labels on products.

Many are concerned that the new lab testing requirements will raise the price of testing too much. In reality, those current prices are not realistic for accurate data, which points to the rampant fraud that ORELAP is trying to eradicate. “The old rules were written in such an ambiguous way that the prices were set by laboratories without a proper quality program or even without proper instrumentation,” says Swantek.

oganalyticalsign — OG Analytical had to close its doors briefly to meet accreditation

The accreditation process will require particularly robust quality control systems in labs. “Accreditation to the TNI Standard means that lab quality systems will require a documentation system, training procedures, record keeping, personnel requirements, organization details, proof of no conflicts of interest and corrective actions if noncompliant,” adds Swantek. “We single out each method or procedure, look at their raw data and proficiency testing and determine if they are meeting the technical requirements.”

According to Voelker, other industries have learned to adjust their costs with stringent lab testing rules. “I get that no one wants to pay more for lab testing, but the reality is that joining the world of commodities comes with additional costs to ensure consumer safety,” says Voelker. These rule changes will undoubtedly bring more consistency to Oregon’s cannabis industry with accurate lab testing and help the OHA shed more light on issues surrounding consumer safety.