Tag Archives: laboratories

Quality Assurance In The Field: Instruments For Growers & Processors

By Aaron G. Biros
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As the cannabis marketplace evolves, so does the technology. Cultivators are scaling up their production and commercial-scale operations are focusing more on quality. That greater attention to detail is leading growers, extractors and infused product manufacturers to use analytical chemistry as a quality control tool.

Previously, using analytical instrumentation, like mass spectrometry (MS) or gas chromatography (GC), required experience in the laboratory or with chromatography, a degree in chemistry or a deep understanding of analytical chemistry. This leaves the testing component to those that are competent enough and scientifically capable to use these complex instruments, like laboratory personnel, and that is still the case. As recent as less than two years ago, we began seeing instrument manufacturers making marketing claims that their instrument requires no experience in chromatography.

Instrument manufacturers are now competing in a new market: the instrument designed for quality assurance in the field. These instruments are more compact, lighter and easier to use than their counterparts in the lab. While they are no replacement for an accredited laboratory, manufacturers promise these instruments can give growers an accurate estimate for cannabinoid percentages. Let’s take a look at a few of these instruments designed and marketed for quality assurance in the field, specifically for cannabis producers.

Ellutia GC 200 Series

Shamanics, a cannabis extractor in Amsterdam, uses Ellutia’s 200 series for QA testing

Ellutia is an instrument manufacturer from the UK. They design and produce a range of gas chromatographs, GC accessories, software and consumables, most of which are designed for use in a laboratory. Andrew James, marketing director at Ellutia, says their instrument targeting this segment was originally designed for educational purposes. “The GC is compact in size and lightweight in stature with a full range of detectors,” says James. “This means not only is it portable and easy to access but also easy to use, which is why it was initially intended for the education market.”

Andrew James, marketing director at Ellutia

That original design for use in teaching, James says, is why cannabis producers might find it so user-friendly. “It offers equivalent performance to other GC’s meaning we can easily replace other GC’s performing the same analysis, but our customers can benefit from the lower space requirement, reduced energy bills, service costs and initial capital outlay,” says James. “This ensures the lowest possible cost of ownership, decreasing the cost per analysis and increasing profits on every sample analyzed.”

Shamanics, a cannabis oil extraction company based in Amsterdam, uses Ellutia’s 200 series for quality assurance in their products. According to Bart Roelfsema, co-founder of Shamanics, they have experienced a range of improvements in monitoring quality since they started using the 200 series. “It is very liberating to actually see what you are doing,” says Roelfsema. “If you are a grower, a manufacturer or a seller, it is always reassuring to see what you have and prove or improve on your quality.” Although testing isn’t commonplace in the Netherlands quite yet, the consumer demand is rising for tested products. “We also conduct terpene analysis and cannabinoid acid analysis,” says Roelfsema. “This is a very important aspect of the GC as now it is possible to methylate the sample and test for acids; and the 200 Series is very accurate, which is a huge benefit.” Roelfsema says being able to judge quality product and then relay that information to retail is helping them grow their business and stay ahead of the curve.

908 Devices G908 GC-HPMS

908 Devices, headquartered in Boston, is making a big splash in this new market with their modular G908 GC-HPMS. The company says they are “democratizing chemical analysis by way of mass spectrometry,” with their G908 device. That is a bold claim, but rather appropriate, given that MS used to be reserved strictly for the lab environment. According to Graham Shelver, Ph.D., commercial leader for Applied Markets at 908 Devices Inc., their company is making GC-HPMS readily available to users wanting to test cannabis products, who do not need to be trained analytical chemists.

The G908 device.

Shelver says they have made the hardware modular, letting the user service the device themselves. This, accompanied by simplified software, means you don’t need a Ph.D. to use it. “The “analyzer in a box” design philosophy behind the G908 GC-HPMS and the accompanying JetStream software has been to make using the entire system as straightforward as possible so that routine tasks such as mass axis calibration are reduced to simple single actions and sample injection to results reporting becomes a single button software operation,” says Shelver.

He also says while it is designed for use in the field, laboratories also use it to meet higher-than-usual demand. Both RM3 Labs in Colorado, and ProVerde in Massachusetts, use G908. “RM3’s main goal with the G908 is increased throughput and ProVerde has found it useful in adding an orthogonal and very rapid technique (GC-HPMS) to their suite of cannabis testing instruments,” says Shelver.

Orange Photonics LightLab Cannabis Analyzer

Orange Photonics’ LightLab Cannabis Analyzer

Dylan Wilks, a third generation spectroscopist, launched Orange Photonics with his team to produce analytical tools that are easy to use and can make data accessible where it has been historically absent, such as onsite testing within the cannabis space. According to Stephanie McArdle, president of Orange Photonics, the LightLab Cannabis Analyzer is based on the same principles as HPLC technology, combining liquid chromatography with spectroscopy. Unlike an HPLC however, LightLab is rugged, portable and they claim you do not need to be a chemist to use it.

“LightLab was developed to deliver accurate repeatable results for six primary cannabinoids, D9THC, THC-A, CBD, CBD-A, CBG-A and CBN,” says McArdle. “The sample prep is straightforward: Prepare a homogenous, representative sample, place a measured portion in the provided vial, introduce extraction solvent, input the sample into LightLab and eight minutes later you will have your potency information.” She says their goal is to ensure producers can get lab-grade results.

The hard plastic case is a unique feature of this instrument

McArdle also says the device is designed to test a wide range of samples, allowing growers, processors and infused product manufacturers to use it for quality assurance. “Extracts manufacturers use LightLab to limit loss- they accurately value trim purchases on the spot, they test throughout their extraction process including tests on spent material (raffinate) and of course the final product,” says McArdle. “Edibles manufacturers test the potency of their raw ingredients and check batch dosing. Cultivators use LightLab for strain selection, maturation monitoring, harvesting at peak and tinkering.”

Orange Photonics’ instrument also connects to devices via Wi-Fi and Bluetooth. McArdle says cannabis companies throughout the supply chain use it. “We aren’t trying to replace lab testing, but anyone making a cannabis product is shooting in the dark if they don’t have access to real time data about potency,” says McArdle.

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Ask The Expert: Exploring Cannabis Laboratory Accreditation Part 2

By Aaron G. Biros
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In the first part of this series, Michelle Bradac, senior accreditation officer at the American Association for Laboratory Accreditation (A2LA), told us about the basics of laboratory accreditation, what it means and why it is such a cornerstone of product safety. In this next piece, we sit down with Roger Brauninger, A2LA Biosafety Program manager, to learn why states are looking to lab accreditation in their regulations for the cannabis industry.

Brauninger has worked at A2LA since 1999. As the manager of their biosafety program, his focus is on developing and maintaining accreditation programs in the life sciences. Brauninger has conducted a number of management system assessments to ISO/IEC 17025 and 17020 and also evaluates other assessors in this role.

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Roger Brauninger, A2LA biosafety program manager

He is A2LA’s point person for interacting with organizations working with food and drug safety, human and animal anti-doping, biological and chemical threat agents and since 2014 for issues related to cannabis testing. He is a member of the ASTM D37 Cannabis committee, a group focused on creating standards for cannabis products. He was also a member of the stakeholder panel on strategic food analytical methods (SPSFAM) cannabis potency working group when they were awarded the Official Methods Board (OMB) award for achievement in technical and scientific excellence at the AOAC’s Annual Meeting and Exposition in Atlanta, GA. Brauninger holds an M.S. degree in Cellular, Microbial and Molecular Biology from George Mason University and is a member of the Society for Toxicology, AOAC International and the International Association for Food Protection (IAFP).

In this part of the series, we sit down with Brauninger to learn specific requirements in states, some of the benefits of using ISO/IEC 17025 and the influx of start-up or novice testing laboratories. Stay tuned for part three.

CannabisIndustryJournal: Do all states with legalized medical cannabis require the testing to be performed by an ISO/IEC 17025 accredited laboratory?

Roger Brauninger: No not at present, while most of the states where cannabis is legal do require accreditation; there are some states that have no requirements dealing with ensuring the competence of the testing laboratories, some that require the labs to be accredited to state environmental and drinking water standards, some that require laboratories adhere to Good Laboratory Practices (GLP) requirements and some have no requirements in place currently. Now, there are roughly 13 states that require or recommend accreditation of the testing laboratory to ISO/IEC 17025.

CIJ: If and when cannabis use is accepted federally, how is ISO/IEC 17025 accreditation of testing laboratories beneficial?

Roger: The accreditation process provides a uniform platform to allow for comparability of test results between states. This would also allow for these laboratories to benefit by being able to expand their customer base, if state borders were not an artificially imposed barrier to trade. This could also help to raise the quality of the testing services by allowing for greater participation in realistic accredited proficiency testing programs, which can create greater comparability of methods and results.

CIJ: What are the benefits to the states by choosing to require ISO/IEC 17025 accreditation as a basis for competence of testing laboratories?

Roger: States face the unique challenge, due to the federal illegality of cannabis, that they must craft their own regulatory cannabis program requirements. The ISO/IEC 17025 requirements provides a means upon which to recognize laboratory competence. This saves the states from having to come up with their own laboratory quality management requirements detailing the necessary activities a laboratory must address with respect to documentation, chain of custody, method validation, etc. Because these items are already considered in the standard. ISO/IEC 17025 helps to creates a baseline consistency amongst laboratories between states. And It also helps to   provides for the legal defensibility of the test results. If and when cannabis is legalized on a federal level, a uniform 50 state recognition is possible using ISO/IEC 17025 as the basis of recognition. In short accreditation can help to ensure that test results have greater comparability and reliability; It also provides greater trust and confidence in the labels and the stated ingredients.

CIJ: Many of the laboratories are “starting up”, how is A2LA equipped to deal with the influx of novice laboratories in this field of testing?

Roger: A2LA offers many different relevant training classes, including those on the ISO/IEC 17025 standard itself, (as well as ones that also contain cannabis-specific content), internal auditing, documenting your quality system, etc. for the laboratories. A2LA also is knowledgeable regarding various states’ cannabis regulatory requirements and can help guide the labs through some of the many obstacles they face in order to perform testing in their state.

CIJ: Does A2LA provide any technical assistance to laboratories that are starting up in this industry?

Roger: A2LA has numerous technical assessors who are experts in the analytical technology associated with cannabis testing. Assessors can be hired in a consulting role and act independently of the assessment process (and independent of A2LA). As a consultant, they can also assist in setting up a quality management system in compliance with ISO/IEC 17025.

CIJ: What benefits can be gained from a laboratory seeking accreditation or from a state that requires cannabis testing laboratories to be accredited?

Roger: Accreditation can provide legal defensibility and increased confidence in the test results being able to stand up in court.   It also may help to lower the cost of doing business because it helps to ensure that the test methods are in control by the laboratory and has been shown to be able to reduce the need for repeat testing. Laboratory accreditation has also led to reduced insurance rates in some cases.

Ask The Expert: Exploring Cannabis Laboratory Accreditation Part 1

By Aaron G. Biros
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Laboratories throughout the world and in a variety of industries get accredited to demonstrate their competency. In the cannabis industry, some states are beginning to require it and many labs get accredited even if their state doesn’t require it. So what does accreditation mean and why is it so important?

The International Organization for Standardization (ISO) is a standard-setting organization that works to promote industrial and commercial standards. The standards set by ISO are designed to help prove a product’s safety and quality to a certain minimum level.

The ISO/IEC 17025:2005 standard sets specific requirements to demonstrate the competence of a lab for carrying out tests. It essentially shows customers or regulators that a lab has the skills and scientific know-how to perform testing, certifying the lab is capable. Accreditation means certifying a lab to that standard and is synonymous with both quality and competence of an organization.

Michelle Bradac, senior accreditation officer at A2LA

The American Association for Laboratory Accreditation (A2LA), founded in 1978, is a non-profit, internationally recognized accreditation body in the United States that offers laboratory and laboratory-related accreditation services and training. They have worked in the cannabis industry to accredit a number of cannabis laboratories to the ISO/IEC 17025:2005 standard. In this series of articles, we sit down with experts from A2LA to learn more about cannabis lab accreditation, why it’s so important and some of the challenges labs face when seeking accreditation.

In the first part of this series, we sit down with Michelle Bradac, senior accreditation officer at A2LA, to learn the basics. Michelle earned a bachelor’s degree in Biology at Towson State University and then attended Hood College, earning a master’s certificate in Regulatory Compliance in Biomedical Science. She has worked at A2LA for eight years, assisting in the accreditation of food testing, environmental testing and cannabis testing laboratories to ISO/IEC 17025, as well as performing quality system assessments. She also facilitates a number of accreditation programs including Field Sampling Measurement Organizations, STAC (Air Emissions) and Cannabis Testing. Bradac is also a member of the ASTM Cannabis Working Group and the ACIL Cannabis Working Group.

In the next part of this series, we will hear about specific requirements in states, some of the benefits of using ISO/IEC 17025 and the influx of start-up or novice testing laboratories.

CannabisIndustryJournal: What is Laboratory Accreditation? 

Michelle Bradac: Laboratory accreditation is a formal means of determining and recognizing the technical competence of laboratories to perform specific types of testing, via the use of an independent third party accreditation body. It provides laboratory users a mechanism to identify and select reliable testing organizations. Use of ISO/IEC 17025 as a basis for laboratory accreditation is internationally recognized as THE conformity assessment standard to which laboratories are accredited; it is used in the USA by both Public (State, local, federal (FDA, USDA, CDC, DoD and EPA) and private laboratories for testing of foods & feeds, drugs, cosmetics, tobacco, natural products and cannabis (among other materials and products).

CIJ: How does laboratory accreditation benefit the cannabis testing laboratory? 

Michelle: It provides a framework for continuous improvement and self-correction where the cannabis testing laboratory data management system is independently reviewed and blinded sample Proficiency Testing is encouraged.

CIJ: How does laboratory accreditation benefit the medical cannabis recommending physician?

Michelle: The physician gains a greater degree of assurance that the material provided by the dispensary is what the label says it is. This is especially important in working with patients that are immunocompromised where heavy metals, residual solvents and harmful pesticides could have negative health consequences.

CIJ: How does the testing of medical cannabis by an accredited laboratory benefit the patient?

Michelle: The patient gains increased confidence that the label accurately reflects the potency and chemical properties of the product.

CIJ: What specific challenges does A2LA face in accrediting cannabis testing laboratories?

Michelle: Much of the typical infrastructure is lacking or only now being developed. This ranges from proficiency testing programs, Reference Material Producers, method development and sampling procedures. There is also difficulty in ensuring that laboratories are appropriately validating methods in states where cannabis product is not yet available.

CIJ: Why is A2LA the optimal choice for ensuring the quality and reliability of the results produced by medical marijuana testing laboratories?

Michelle: A2LA has by far the most experience as an accreditor of laboratories that perform testing of natural plant products. We have been performing assessments of and granting accreditation to these types of laboratories for over twenty years. This results in our staff and our assessor corps who are then able to provide valuable insight and technical sophistication that other accreditation bodies do not have. Specific to the cannabis industry, A2LA is also represented in all the major standards development organizations, tradeshows and industry groups; which strengthens our understanding of the industry and ability to assist our customers towards meeting their goal of obtaining accreditation.

PA Approves First Two Cannabis Labs

By Aaron G. Biros
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According to a PennLive article, Pennsylvania’s Department of Health approved the first two cannabis laboratories for their medical cannabis program. ACT Laboratories of Pennsylvania LLC and Keystone State Testing LLC are the companies that were approved to perform analytical testing for safety and quality in cannabis products.

Both laboratories expect to be operational before the end of 2017, according to the PennLive article. Those labs are required to test for CBD and THC content, pesticides, moisture content, residual solvents and microbiological contaminants.

The temporary lab testing regulations are somewhat comprehensive, detailing lab reporting, licensing, sampling protocols and ownership stipulations, among other rules. ACT and Keystone, the labs that were approved by the Department of Health, have their approval for two years and can renew their license after.

While the state still expects the program to be fully implemented by 2018, Health Secretary and Physician General Dr. Rachel Levine said last week they are hoping to launch the program sometime next year, according to a press release. December 2017 will mark a full year since the state opened applications for licensing businesses.

January 2018 has long been the goal for the full implementation of the program. “We have made significant progress in getting this program off the ground since Governor Wolf signed the Medical Marijuana Act into law last year,” says Dr. Levine. “These proposed regulations for patients and caregivers to participate are one of the final pieces we need to have in place to launch the program sometime next year.”

Digipath Expands To California

By Aaron G. Biros
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In July, we sat down with the folks at Digipath, Inc. when they received their testing license in Nevada for the adult use market. In that conversation, they mentioned they were looking to expand into California.

According to a press release published September 25th, DigiPath, Inc. has entered a joint venture to establish their first cannabis-testing lab in California. They will be working with Don Ashley, an experienced real estate developer and cannabis entrepreneur, to launch Humboldt Botanical, LLC, conducting business under the name “Digipath Botanical Testing”.

Ashley says they expect to be fully operational by Q1 of 2018. “We expect to break ground on this project in the next few weeks and hope to be operational in early Q1 2018 just after the state-wide adult-use market is expected to launch, as we have already obtained approval from the local planning authorities for the entire complex,” says Ashley.

Todd Denkin, founder and president of Digipath

Todd Denkin, president of Digipath, is optimistic for California’s market and the coming regulations. “The state of California is estimated to be the single largest cannabis market in the U.S. Adult-use cannabis legislation was approved by California residents last November, and we expect these new regulations to be implemented in 2018,” says Denkin. “The good news for the industry is that the requirements for cannabis testing will be significant, and we are excited to partner with Don and his team to pursue this opportunity in Humboldt County.”

Ashley is contributing roughly $2 million to build and equip the lab with instrumentation, while Digipath Labs will manage and supervise operations at the lab. According to the press release, Digipath will provide a non-exclusive license to use its intellectual property for the operation of the lab. Digipath Labs will retain rights over all the scientific data generated in the lab.

Cindy Orser, PhD., chief science officer at Digipath

According to Cindy Orser, PhD., chief science officer at Digipath, that data will be put to good use. “Digipath Labs has developed an algorithm for use in strain authentication based largely on terpene profiling from our testing lab in Nevada and we are eager to further test our hypothesis with an expanded dataset from cannabis grown in Northern California,” says Orser.

While testing labs are primarily seen as safeguards for public health and safety, using data to correctly identify strains is a relatively new concept. “Digipath Labs is all about public health and safety through testing for adulterants,” says Orser. “Another component to quality is having confidence in product authenticity at the dispensary level. Not only is the consumer buying quality assured products but truth in advertising when it comes to strain nomenclature.”

Denkin says they were proactive in working toward getting the license early on. “Our partners have been dealing with the local regulators while we have been providing the proper SOP’s for the local government in order to receive the proper licensure in the area,” says Denkin. Taking their experience from Nevada to California, Orser says they have been asked to present to the California Toxicology Association on their experience with cannabis testing in the highly regulated marketplace of Nevada.

The laboratory in Humboldt is going to be part of a “cannabis industrial park,” alongside an R&D facility, oils/concentrate manufacturing center, health and wellness center, distribution and processing facility, tissue culture nursery, hemp clothing outlet, and coffee bistro, according to the press release.

Looking forward to growing their business, Denkin says they hope to launch a lab in Southern California. “We do expect to have a larger footprint in California because of the size of the market and are looking for locations in Southern California as well,” says Denkin. When asked about any new plans to expand elsewhere, Denkin says they’ll let us know. “We are continuing with our business plan and actively seeking the right mergers and acquisitions. Stay tuned.”

Nevada Cannabis Lab License Suspended

By Aaron G. Biros
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Last month, G3 Labs LLC, a Las Vegas-based cannabis-testing lab, had their license suspended for an unknown regulatory compliance issue. According to Stephanie Klapstein, spokeswoman for the Nevada Department of Taxation, the reason why their license was suspended is confidential. “We can’t disclose the details of the suspension, including anything about penalties,” says Klapstein.

When asked about the license suspension, Klapstein told us it was a compliance issue, but could not go into detail. “I can confirm that we did suspend G3’s license for compliance issues,” says Klapstein. “We are working with them to bring them back into compliance. In the meantime, they cannot operate.” Klapstein told the Las Vegas Review-Journal that the Nevada Department of Agriculture tested cannabis samples from the lab to determine if there was a need for a recall. She also confirmed with us that the compliance issue does not necessitate any product recalls.

According to the Las Vegas Review-Journal, this is the first time a cannabis business license is suspended in the state since the beginning of adult-use sales back in July of this year. Nevada’s cannabis regulations require independent lab testing of products before they reach shelves. That required testing includes checking for potency, microbials, pesticides, residual solvents, moisture content, growth regulators, Mycotoxins and foreign matter.

When we reached out to G3 Labs, they did not immediately respond to a request for comment.

Dr. Chao-Hsiung Tung, lab director at G3 Labs, told the Las Vegas Review-Journal that they couldn’t comment, based on advice from their legal counsel. “G3 Labs is actively sorting out the issues with the Department,” Dr. Tung told the Review-Journal in an email.

EVIO Labs Expands To Florida

By Aaron G. Biros
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Currently, there are no lab testing regulations for Florida’s medical cannabis market. Chris Martinez, co-founder and chief operating officer of EVIO Labs Florida, a veteran-owned business, is looking to change that.

Chris Martinez, co-founder and chief operating officer of EVIO Labs Florida

When Martinez co-founded EVIO Labs Florida, he saw the need for a dedicated cannabis lab to ensure safety and quality of medicine for patients in the state. Partnering with EVIO Labs to accomplish this goal, Martinez secured a 5,500 sq. ft. facility in Broward County to test for potency, pesticides, microbial contaminants, terpenes, residual solvents and heavy metals. Their lab, a first of its kind in the industry, qualifies as a true pharmaceutical-grade clean room. This week, Martinez also secured their 2nd laboratory location in the City of Gainsville, where they will test for potency, microbials, terpenes and residual solvents. And he isn’t doing it on the cheap. “Our Broward lab is powered by Shimadzu with over $1.2M in the latest testing equipment utilizing LCMS technology with the world’s fastest polarity switching time of 5 m/sec and scan speeds of 30,000 u/sec with UF Qarray sensitivity 90 times that of previously available technologies,” says Martinez.

Martinez, an entrepreneur at heart, started the lab with a team of experts to become the first completely cannabis-focused laboratory in Florida. Jorge Segredo, their head chemist and quality assurance director, has over 18 years of experience in the development of nutraceutical and pharmaceutical products under ISO and FDA accreditation. Segredo has helped launch three independent FDA-accredited laboratories and has extensive knowledge of HPLC, GCMS, LCMS, ICPMS technologies and development/validation of testing methods and procedures. Cynthia Brewer, their director of operations, was an active participant in the 2017 state legislative session and has been an advocate for medical cannabis, working with legislators on a suitable framework to increase patient access to cannabis.

The EVIO team is using instruments from Shimadzu

EVIO is one of the nation’s leaders in cannabis testing, research science and advisory services. It is an evolving network of laboratories with nine EVIO cannabis laboratories operating in five different states: Oregon, Colorado, Massachusetts, Florida and California. “After speaking with industry chemists around the country for months, the EVIO name was constantly brought up in conversation,” says Martinez. “When we spoke with the EVIO Team it was an easy decision for us to partner.” He says Lori Glauser, chief operating officer of EVIO, and William Waldrop, chief executive officer of EVIO, are truly visionaries in the cannabis industry.

According to Martinez, their licensing agreement with EVIO Labs (OTC:SGBYD) marked a first for the publicly traded company with exclusivity in the Florida market. The agreement includes proprietary testing methodologies, operating procedures, training and support.

In addition to testing cannabis for safety and quality, they are launching a technology platform called MJ Buddy, essentially a software tool that takes efficacy feedback from patients and uses testing and genetic data they gather from EVIO Labs across the country. “This will provide real data to the cannabis industry as to the medical benefits for thousands of patients in relation to the genotype and cannabinoid profiles of their medicine,” says Martinez.

Of the states that have legalized some form of cannabis, a large number of them have some lab testing regulations on the book, with some more comprehensive than others. Martinez says he hopes the Florida Department of Health, Office of Medical Marijuana Use follows some of the more thorough state programs, such as Oregon. His team has compiled a set of documents for regulators with recommendations for regulating the lab testing industry.

Without any regulations on paper, it is up to businesses to produce safe and quality medicine, without any oversight. EVIO Labs Florida follows FDA Good Laboratory Practices, has an ISO 17025:2005 accreditation pending, and is working on TNI 2016 accreditation.

When discussing what he wants to see happen with Florida’s regulatory framework, Martinez says the rules need to be specific to Florida. For example, due to the climate being so humid, microbial contaminant testing for things like yeast and mold will be particularly imperative. Because processing methods like butane and alcohol extraction are legal, he emphasizes the need for comprehensive residual solvents testing. “The most important regulation would be to have the laboratories select the samples at the MMTC facility and have the state randomly verify laboratory results to ensure accurate unbiased testing,” says Martinez.

In addition to that, he hopes their pesticide thresholds will be realistic and based on actual science. “We believe the public should receive carcinogenic data for products that are inhaled,” says Martinez. “Chemicals may be introduced into the processing of cannabis to vape liquid that may cause harm. This is important information for public health and communication of the risk related to exposure to such materials.” Martinez says EVIO Labs Florida was founded on the belief that through technology and science we can increase safety and patient outcomes.

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Colorado Approves Emerald Scientific Proficiency Tests for Regulatory Compliance in Cannabis Testing

By Aaron G. Biros
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Emerald Scientific recently announced their proficiency-testing program, The Emerald Test, has been approved by Colorado as a third party provider for proficiency testing in licensed cannabis laboratories. The Emerald Test, held twice annually, is an inter-laboratory comparison and proficiency test (ILC-PT), allowing data to be collected pertaining to the performance of laboratories on a national scale. Proficiency testing is designed to measure how accurately laboratories perform and is a critical tool for quality assurance.

Colorado requires labs to participate in a proficiency-testing program in order to be certified to conduct required testing on cannabis and cannabis products for safety and quality. According to the press release, Colorado’s Marijuana Enforcement Division, under the Department of Revenue, conducted an evaluation process to determine which applicants could meet the performance standards for regulatory compliance concerning proficiency testing. The contract was awarded to Emerald Scientific following this evaluation process.

emerald test retailAccording to Ken Groggel, director of the Proficiency Testing Program at Emerald Scientific, a number of states have recognized the need for independent proficiency testing as a required piece of regulatory compliance. “The Emerald Test Inter-Laboratory Comparison/PT is state approved in Washington & Colorado for cannabis testing laboratory licensure,” says Groggel. “States with cannabis or hemp production, as well as labs in other countries are now actively participating in the Emerald Test as a tool for quality improvement, efficiency upgrades and product safety.” He says the Colorado Marijuana Enforcement Division has contracted with Emerald Scientific to provide third party PT programs for microbial contaminants, residual solvents and pesticides.

Ken Groggel, director of the Proficiency Testing Program at Emerald Scientific

Beginning in 2014, The Emerald Test has been offered twice a year and, in 2017, over 50 labs participated from 14 states and 2 countries. “Laboratories that have enrolled more than once have seen significant improvement in their results, an indicator of improved performance for industry customers,” says Groggel.

Proficiency testing is important for ensuring quality, safety and product content accuracy. “This should be the priority whether you are a grower, manufacturer, testing laboratory, regulatory entity, medical patient or adult use consumer,” says Groggel. It also helps labs meet regulatory requirements and achieve ISO 17025 accreditation. “Independent proficiency testing helps determine if the lab is able to deliver the services marketed to its customers,” says Groggel. “Regulatory agencies can use this information when licensing, monitoring & enforcing good science for public safety.”

As new states legalize cannabis and develop consumer protection regulations, proficiency testing programs can help labs demonstrate their commitment to responsible and accurate testing. “When PT results show the cannabis testing lab is capable it is up to the government to ensure accountability for performance on behalf of all its citizens,” says Groggel. Labs can enroll starting on September 25th in the Fall 2017 Emerald Test ILC/PT.

JCanna Boot Camp Educates Portland Attendees

By Aaron G. Biros
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On Monday, August 28th, attendees of the Cannabis Science Conference descended on Portland, Oregon for a week of educational talks, networking and studying the science of cannabis. On Monday, Chalice Farms, an extracts and infused products company, hosted the full-day JCanna Boot Camp focused on a deep dive behind the scenes of a cannabis production facility. The Cannabis Science Conference, hosted by Josh Crossney, founder of JCanna, takes place August 28th to 30th.

Attendees touring an extraction setup

Attendees were split into five groups where they listened to a variety of educational sessions and toured the facility. A track focused on cultivation, led by Autumn Karcey, president of Cultivo, Inc., detailed all things facility design for cannabis cultivation, including an in-depth look at sanitation and safety. For example, Karcey discussed HVAC cleanliness, floor-to-ceiling sanitation and the hazards associated with negative pressure. These principles, while applicable to most cultivating facilities, applies particularly to commercial-scale grows in a pharmaceutical setting.

Sandy Mangan and Tristan DeBona demonstrating the grinding technique for sample prep

During one session, Sandy Mangan, accounts manager at SPEX Sample Prep and Tristan DeBona, sales specialist at SPEX Sample Prep, demonstrated the basics of sample preparation for detecting pesticides in infused products, such as gummies. That required using their GenoGrinder and FreezerMill, which uses liquid nitrogen to make gummies brittle, then pulverizing them to a powder-like substance that is more conducive for a QuEChERS preparation.

Joe Konschnik and Susan Steinike demonstrate the QuEChERS method

Joe Konschnik, business development manager at Restek, Susan Steinike, product-marketing manager at Restek and Justin Steimling, an analytical chemist at Restek, gave a demonstration of a full QuEChERS extraction of a cannabis sample for pesticide analysis, with attendees participating to learn the basics of sample preparation for these types of tests.

Following those were some other notable talks, including a tour of the extraction instruments and equipment at Chalice Farms, a look inside their commercial kitchen and a discussion of edibles and product formulation. Dr. Uma Dhanabalan, founder of Uplifting Health and Wellness, a physician with over 30 years of experience in research and patient care, led a discussion of physician participation, patient education and drug delivery mechanisms.

Amanda Rigdon, Emerald Scientific, showing some complex matrices in cannabis products

Amanda Rigdon, chief technical officer of Emerald Scientific, offered a demonstration of easy and adaptable sample preparation techniques for potency testing of infused product matrices. Rigdon showed attendees of the boot camp how wildly diverse cannabis products are and how challenging it can be for labs to test them.

The JCanna Canna Boot Camp is a good example of an educational event catered to the cannabis industry that offers real, hands-on experience and actionable advice. Before the two-day conference this week, the boot camp provided a bird’s eye view for attendees of the science of cannabis.

Ask the Expert: Q&A with Steve Stadlmann on Cannabis lab Accreditation

By Aaron G. Biros
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Steve Stadlmann has an extensive background as an analytical chemist working in laboratories since the early 90’s. He is now a sales specialist at PerkinElmer, an analytical instrument manufacturer that provides instruments for cannabis testing labs, in addition to a host of other industries. With over two decades of experience working in environmental testing labs, food and beverage labs and agricultural testing labs, Stadlmann is extremely familiar with the instruments used in cannabis labs.

Steve Stadlmann, sales specialist at Perkin Elmer

In 2014, he started working in the cannabis space with TriQ, Inc., a technology solutions provider for cannabis growers, where he worked in product development on a line of nutrients. In April of 2016, he started working at Juniper Analytics, a cannabis-testing laboratory in Bend, Oregon. As laboratory director there, he created their quality manual, quality assurance plan, SOP’s and all the technical documentation for ORELAP accreditation. He developed new methodologies for cannabis testing industry for residual solvents, terpene profiles and potency analysis. He worked with PerkinElmer on pesticide methodology for the QSight™ Triple Quadrupole LC/MS/MS system and implemented operational procedures and methods for LC-UV, GCMS and LC-MS/MS, including sample prep for cannabis products.

He left Juniper Analytics about two months ago to work with PerkinElmer as a sales specialist. With extensive experience in helping get Juniper’s lab accredited, he is a wealth of knowledge on all things cannabis laboratory accreditation. PerkinElmer will be hosting a free webinar on September 12th that takes a deep dive into all things cannabis lab accreditation. Ahead of the upcoming webinar, Getting Accreditation in the Cannabis Industry, we sit down with Stadlmann to hear his observations on what instruments he recommends for accreditation, and processes and procedures to support that. Take a look at our conversation below to get a glimpse into what this webinar will discuss.

CannabisIndustryJournal: How can cannabis labs prepare for accreditation with selecting instrumentation?

Steve: Finding the appropriate instrumentation for the regulations is crucial. Ensuring the instrumentation not only has the capabilities of analyzing all the required compounds, but also able to achieve appropriate detection limit requirements. In addition, having an instrument manufacturer as a partner, that is willing and able to assist in method development, implementation and continued changes to the testing requirements at the state level (and potentially national level) is key.

Another consideration is robustness of the equipment. The instrumentation must be capable of high throughput for fast turnaround times of results. Unlike the environmental industry, the cannabis industry has consumer products with expiration dates. Clients demand quick turnaround of results to get product to market as quickly as possible and avoid sitting on inventory for any length of time.

To add to the robustness need, sample matrices in the cannabis industry can be quite challenging in relation to analytical instrumentation. Equipment that is able to handle these matrices with minimal downtime for routine service is becoming a requirement to maintain throughput needs of the industry.

CIJ: What are the most crucial procedures and practices for achieving ISO 17025 accreditation?

Steve: Development and documentation of processes and procedures following Good Laboratory Practices and procedures is essential to a successful accreditation process. Great attention must be paid to the quality objectives of the laboratory as well as associated documentation, including tracking of any errors, deviations, updates, complaints, etc.

Data integrity is a key component to any accrediting body and includes implementation and/or development of appropriate methods with support data proving acceptable results. In addition, documentation of all procedures and processes along with tracking of all steps in the process during routine laboratory work should be a priority. The ability to show a complete, documented trail of all procedures done to any sample is important in ensuring the results can be reproduced and ensuring no deviations occurred, in turn potentially causing questionable results.

Last but not least: training. Laboratory staff should be well versed in any procedures they are involved in to ensure high data quality and integrity. If any laboratory staff does not receive appropriate training in any operating procedures, the data quality becomes suspect.

CIJ: What are some of the biggest obstacles or pitfalls cannabis labs face when trying to get accredited?

Steve: Not fully preparing to meet any agency and testing regulations and requirements will cause delays in the accreditation process and potentially more work for the laboratory. From documentation to daily operations, if any aspect becomes a major finding for an auditor, additional data is usually required to prove the error has been fixed satisfactorily.

Taking the time early on to ensure all documentation, processes and procedures are adhering to any regulatory agency requirements is important for a smooth accreditation process. It is easy to overlook small details when building out the operating procedures that might be essential in the process. Again, going back to data quality, the laboratory must ensure all steps are outlined and documented to ensure high quality (reproducible) data and integrity.

A new employee should be able to come in and read a quality manual and standard operating procedure and produce equivalent data to any laboratory analyst doing the same job. With difficult or challenging operating procedures it becomes even more important that training and documentation are adhered to.


PerkinElmer’s free webinar will dive into these points and others in more detail. To learn more and sign up, click here.