Tag Archives: lab

February 7, 2018

Managing Cannabis Testing Lab Workflows using LIMS

By Dr. Susan Audino

With the state led legalization of both adult recreational and medical cannabis, there is a need for comprehensive and reliable analytical testing to ensure consumer safety and drug potency. Cannabis-testing laboratories receive high volumes of test requests from cannabis cultivators for testing quantitative and qualitative aspects of the plant. The testing market is growing as more states bring in stricter enforcement policies on testing. As the number of testing labs grow, it is anticipated that the laboratories that are now servicing other markets, including high throughput contract labs, will cross into cannabis testing as regulations free up. As the volume of tests each lab performs increases, the need for laboratories to make effective use of time and resource management, such as ensuring accurate and quick results, reports, regulatory compliance, quality assurance and many other aspects of data management becomes vital in staying competitive.

Cannabis Testing Workflows

To be commercially competitive, testing labs offer a comprehensive range of testing services. These services are available for both the medical and recreational cannabis markets, including:

Detection and quantification of both acid and neutral forms of cannabinoids
Screening for pesticide levels
Monitoring water activity to indicate the possibility of microbiological contamination
Moisture content measurements
Terpene profiling
Residual solvents and heavy metal testing
Fungi, molds, mycotoxin testing and many more

Although the testing workflows differ for each test, here is a basic overview of the operations carried out in a cannabis-testing lab:

Cannabis samples are received.
The samples are processed using techniques such as grinding and homogenization. This may be followed by extraction, filtration and evaporation.
A few samples will be isolated and concentrated by dissolving in solvents, while others may be derivatized using HPLC or GC reagents
The processed samples are then subjected to chromatographic separation using techniques such as HPLC, UHPLC, GC and GC-MS.
The separated components are then analyzed and identified for qualitative and quantitative analysis based on specialized standards and certified reference materials.
The quantified analytical data will be exported from the instruments and compiled with the corresponding sample data.
The test results are organized and reviewed by the lab personnel.
The finalized test results are reported in a compliant format and released to the client.

In order to ensure that cannabis testing laboratories function reliably, they are obliged to follow and execute certain organizational and regulatory protocols throughout the testing process. These involve critical factors that determine the accuracy of testing services of a laboratory.

Factors Critical to a Cannabis Testing Laboratory

Accreditations & Regulatory Compliance: Cannabis testing laboratories are subject to regulatory compliance requirements, accreditation standards, laboratory practices and policies at the state level. A standard that most cannabis testing labs comply to is ISO 17025, which sets the requirements of quality standards in testing laboratories. Accreditation to this standard represents the determination of competence by an independent third party referred to as the “Accreditation Body”. Accreditation ensures that laboratories are adhering to their methods. These testing facilities have mandatory participation in proficiency tests regularly in order to maintain accreditation.
Quality Assurance, Standards & Proficiency Testing: Quality assurance is in part achieved by implementing standard test methods that have been thoroughly validated. When standard methods are not available, the laboratory must validate their own methods. In addition to using valid and appropriate methods, accredited laboratories are also required to participate in appropriate and commercially available Proficiency Test Program or Inter-Laboratory Comparison Study. Both PT and ILC Programs provide laboratories with some measure of their analytic performance and compare that performance with other participating laboratories.
CloudLIMS Cannabis Testing LIMS: Multi-analyte Configuration for Cannabis Testing Services
Real-time Collaboration: Testing facilities generate metadata such as data derived from cannabis samples and infused products. The testing status and test results are best served for compliance and accessibility when integrated and stored on a centralized platform. This helps in timely data sharing and facilitates informed decision making, effective cooperation and relationships between cannabis testing facilities and growers. This platform is imperative for laboratories that have grown to high volume throughput where opportunities for errors exist. By matching test results to samples, this platform ensures consistent sample tracking and traceability. Finally, the platform is designed to provide immediate, real-time reporting to individual state or other regulatory bodies.
Personnel Management: Skilled scientific staff in cannabis-testing laboratories are required to oversee testing activities. Staff should have experience in analytical chromatography instruments such as HPLC and GC-MS. Since samples are often used for multi-analytes such as terpenes, cannabinoids, pesticides etc., the process often involves transferring samples and tests from one person to another within the testing facility. A chain of custody (CoC) is required to ensure traceability and ‘ownership’ for each person involved in the workflow.

LIMS for Laboratory Automation

Gathering, organizing and controlling laboratory-testing data can be time-consuming, labor-intensive and challenging for cannabis testing laboratories. Using spreadsheets and paper methods for this purpose is error-prone, makes data retrieval difficult and does not allow laboratories to easily adhere to regulatory guidelines. Manual systems are cumbersome, costly and lack efficiency. One way to meet this challenge is to switch to automated solutions that eliminate many of the mundane tasks that utilize valuable human resources.^. Laboratory automation transforms the data management processes and as a result, improves the quality of services and provides faster turnaround time with significant cost savings. Automating the data management protocol will improve the quality of accountability, improve technical efficiency, and improve fiscal resources.

Real Time Test Status in CloudLIMS

A Laboratory Information Management System (LIMS) is a software tool for testing labs that aids efficient data management. A LIMS organizes, manages and communicates all laboratory test data and related information, such as sample and associated metadata, tests, Standard Operating Procedures (SOPs), test reports, and invoices. It also enables fully automated data exchange between instruments such as HPLCs, GC-FIDs, etc. to one consolidated location, thereby reducing transcription errors.

How LIMS Helps Cannabis Testing Labs

LIMS are much more capable than spreadsheets and paper-based tools for streamlining the analytical and operational lab activities and enhances the productivity and quality by eliminating manual data entry. Cloud-enabled LIMS systems such as CloudLIMS are often low in the total cost of acquisition, do not require IT staff and are scalable to help meet the ever changing business and regulatory compliance needs. Some of the key benefits of LIMS for automating a cannabis-testing laboratory are illustrated below [Table 1]:

Key Functionality	Benefit
Barcode label designing and printing	Enables proper labelling of samples and inventory Follows GLP guidelines
Instant data capture by scanning barcodes	Facilitates quick client registration and sample access
360⁰ data traceability	Saves time and resources for locating samples and other records
Inventory and order management	Supports proactive planning/budgeting and real time accuracy
Custodian management	Promotes overall laboratory organization by assigning custodians for samples and tests Maintains the Chain-of-custody (CoC)
Test management	Accommodates pre-loaded test protocols to quickly assign tests for incoming samples
Accounting for sample and inventory quantity	Automatically deducts sample and inventory quantities when consumed in tests
Package & shipment management	Manages incoming samples and samples that have been subcontracted to other laboratories
Electronic data import	Electronically imports test results and metadata from integrated instruments Eliminates manual typographical errors
Report management	Generates accurate, customizable, meaningful and test reports for clients Allows user to include signatures and additional sections for professional use
21 CFR Part 11 compliant	Authenticates laboratory activities with electronic signatures
ISO 17025 accreditation	Provides traceable documentary evidence required to achieve ISO 17025 accreditation
Audit trail capabilities	Adheres to regulatory standards by recording comprehensive audit logs for laboratory activities along with the date and time stamp
Centralized data management	Stores all the data in a single, secure database facilitating quick data retrieval
Workflow management	Promotes better data management and resource allocation
High-configurability	Enables modification of screens using graphical configuration tools to mirror testing workflows
State compliance systems	Integrates with state-required compliance reporting systems and communicates using API
Adheres to regulatory compliance	Creates Certificates of Analysis (CoA) to prove regulatory compliance for each batch as well as batch-by-batch variance analysis and other reports as needed.
Data security & confidentiality	Masks sensitive data from unauthorized user access Cloud-based LIMS encrypts data at rest and in-transit while transmission between the client and the server
Global accessibility	Cloud-based LIMS provides real-time access to laboratory data from anytime anywhere
Real-time collaboration	Cloud-based LIMS enhances real-time communication within a laboratory, between a laboratory and its clients, and across a global organization with multiple sites

Table 1. Key functionality and benefits of LIMS for cannabis testing laboratories

Upon mapping the present day challenges faced by cannabis testing laboratories, adopting laboratory automation solutions becomes imperative. Cloud-based LIMS becomes a valuable tool for laboratory data management in cannabis testing laboratories. In addition to reducing manual workloads, and efficient resource management, it helps labs focus on productive lab operations while achieving compliance and regulatory goals with ease.

For more information on this, check out a webinar here: Webinar: How to Meet Cannabis Testing Standards and Regulatory Requirements with LIMS by Stephen Goldman, laboratory director at the State of Colorado certified Cannabis testing facility, PhytaTech.

February 7, 2018

EVIO Labs: The First Accredited Cannabis Lab in Florida

By Lauren Masko

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EVIO Labs recently became the first cannabis laboratory in Florida to obtain ISO 17025 accreditation. Perry Johnson Laboratory Accreditation, Inc. (PJLA), an organization that provides third-party assessments to ISO/IEC 17025, accredited EVIO Labs. The assessment process that lead to ISO 17025 accreditation for EVIO Labs included a thorough review of their quality management system, their capability to perform potency and contaminant testing for cannabis products.

Tracy Szerszen, president and operations manager at PJLA, encourages this international standard for laboratories to provide confidence to end-users that the test results they receive are reliable. She says laboratories that achieve this accreditation are showing they have the proper tools, equipment and staff to provide accurate testing. “It is a very critical component of the industry, and becoming accredited provides the assurance that laboratories are performing to the highest standard,” says Szerszen. “EVIO Labs has taken the right step in their commitment towards meeting this standard and providing clean and safe cannabis for the patients of Florida.”

EVIO Labs provides cannabis testing for cannabinoid and terpene profiles, microbiological and pesticides contamination, residual solvent, heavy metals, mycotoxins, water activity and moisture content. Chris Martinez, co-founder and president of EVIO Labs Florida explains that the Florida Department of Health mandates that an independent third-party laboratory tests medical cannabis to ensure that these products are safe for human consumption. Martinez says their first priority is the safety of their patients, and ensuring that EVIO Labs provides clean and safe cannabis for Florida.

Chris Martinez, co-founder and president of EVIO Labs Florida

Martinez launched their laboratory with some help from Shimadzu last year. “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. 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.

Every certificate of analysis is reviewed by a lab director with over 20 years of experience operating in FDA regulated labs. Martinez says that EVIO has some of the most advanced technology in the industry, which provides them the opportunity to quickly provide results, frequently as fast as a 24-hour period. Martinez and his team are currently building a 3,300 square-foot laboratory in Gainesville, which is expected to be running by March of this year.

January 31, 2018

Growing Pains a Month Into California’s Market Launch

By Aaron G. Biros

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For about a month now, California’s adult use market has been open for business and the market is booming. About thirty days into the world’s largest adult use market launch, we are beginning to see side effects of the growing pains that come with adjusting the massive industry.

Consumers are also feeling sticker shock as the new taxes add up to a 40% increase in price.While the regulatory and licensing roll out has been relatively smooth, some municipalities are slower than others in welcoming the adult use cannabis industry. It took Los Angeles weeks longer than other counties to begin licensing dispensaries. Meanwhile, retailers in San Diego say the first month brought a huge influx of customers, challenging their abilities to meet higher-than-expected demand.

Businesses are struggling to deal with large amounts of cash, but California State Treasurer John Chiang may have a solution in store. Yesterday, his department announced they are planning to create a taxpayer-backed bank for cannabis businesses.

Reports of possible supply shortages are irking some businesses, fearing that the state hasn’t licensed enough growers and distributors to handle the high demand. Consumers are also feeling sticker shock as the new taxes add up to a 40% increase in price.

CA cannabis testing chart — California’s plan for phasing in testing requirements.

In the regulatory realm, some are concerned that a loophole in the rules allows bigger cultivation operations to squeeze out the competition from smaller businesses. The California Growers Association filed a lawsuit against the California Department of Food and Agriculture to try and close this loophole, hoping to give smaller cultivators a leg up before bigger companies can dominate the market.

The Bureau of Cannabis Control (known as just “The Bureau”) began holding meetings and workshops to help cannabis businesses get acquainted with the new rules. Public licensing workshops in Irvine and San Diego held last week were designed to focus on information required for licensing and resources for planning. The Bureau also held their first cannabis advisory committee meeting, as well as announcing new subcommittees and an input survey to help the Bureau better meet business needs.

On the lab-testing front, the state has phased in cannabinoids, moisture content, residual solvent, pesticide, microbial impurities and homogeneity testing. On July 1, the state will phase in additional residual solvent and pesticide testing in addition to foreign material testing. At the end of 2018, they plan on requiring terpenoids, mycotoxins, heavy metals and water activity testing as well.

January 18, 2018

Nevada Testing Lab Licenses Suspended, Then Reinstated

By Aaron G. Biros

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When Nevada legalized adult use sales this past summer, the market exploded and undoubtedly flooded licensed testing labs with samples to get products on shelves. In August, roughly a month after the start of adult use sales, a Las Vegas cannabis-testing lab, G3 Labs, had their license suspended for an unknown compliance issue.

“We can’t disclose the details of the suspension, including anything about penalties,” said Klapstein. “Under NRS 360.255, the information is confidential.”Then in late December, the Nevada Department of Taxation, one of the bodies tasked with regulating the state’s industry, announced in an email they suspended two more cannabis testing lab licenses. Certified Ag Lab in Sparks, Nevada and Cannex Nevada, LLC, in Las Vegas (also known as RSR Analytical Laboratories) both had their licenses suspended on December 22 and December 26 respectively.

Stephanie Klapstein, spokeswoman for the Department of Taxation, told the Reno Gazette Journal that both of those labs were not following proper protocols. “During separate, routine inspections, Department inspectors discovered that these two labs were not following proper lab procedures and good laboratory practices,” says Klapstein. “Their licenses were suspended until those deficiencies were corrected.”

According to the Reno Gazette Journal, both of those labs had their licenses reinstated and have since resumed normal business. During their license suspension, the labs were not allowed to operate and the department directed licensed cannabis businesses to submit samples to other labs. The department also directed the suspended labs in the email to coordinate with their clients who had samples in for testing; to either have their samples transferred to a different lab or a new sample taken for another lab to test. They did note that no product recalls were deemed necessary because of the suspension.

In that same email, the department directed licensed cannabis businesses to state-licensed labs in good standing, including 374 Labs, ACE Analytical Laboratory, DB Labs, Digipath Labs, MM Lab and NV CANN Lab. But on the department’s website, it says there are 11 licensed testing labs.

Back in September when we reported on the first lab license suspension, Klapstein told CIJ that under state law they couldn’t discuss any reasons behind why they suspended licenses. “We can’t disclose the details of the suspension, including anything about penalties,” said Klapstein. “Under NRS 360.255, the information is confidential.”

Because of that confidentiality, there are a number of questions left unanswered: With three lab licenses suspended in the first six months of the Nevada’s adult use market being open, how are testing labs keeping up with the market’s pace? What did those suspended labs do wrong? Do the regulations adequately protect public health and safety?

January 10, 2018

Microbiology 101 Part Two

By Kathy Knutson, Ph.D.

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Microbiology 101 Part One introduced the reader to the science of microbiology and sources of microbes. In Part Two, we discuss the control of microorganisms in your products.

Part 2

The cannabis industry is probably more informed about patients and consumers of their products than the general food industry. In addition to routine illness and stress in the population, cannabis consumers are fighting cancer, HIV/AIDS and other immune disorders. Consumers who are already ill are immunocompromised. Transplant recipients purposely have their immune system suppressed in the process of a successful transplant. These consumers have pre-existing conditions where the immune system is weakened. If the immunocompromised consumer is exposed to viral or bacterial pathogens through cannabis products, the consumer is more likely to suffer from a viral infection or foodborne illness as a secondary illness to the primary illness. In the case of consumers with weakened immune systems, it could literally kill them.Bacteria, yeast, and mold are present in all environments.

The cannabis industry shoulders great responsibility in both the medical and adult use markets. In addition to avoiding chemical hazards and determining the potency of the product, the cannabis industry must manufacture products safe for consumption. There are three ways to control pathogens and ensure a safe product: prevent them from entering, kill them and control their growth.

Prevent microorganisms from getting in

Think about everything that is outdoors that will physically come in a door to your facility. Control the quality of ingredients, packaging, equipment lubricants, cleaning agents and sanitizers. Monitor employee hygiene. Next, you control everything within your walls: employees, materials, supplies, equipment and the environment. You control receiving, employee entrance, storage, manufacturing, packaging and distribution. At every step in the process, your job is to prevent the transfer of pathogens into the product from these sources.

Kill microorganisms

Colorized low-temperature electron micrograph of a cluster of E. coli bacteria.
Image courtesy of USDA ARS & Eric Erbe

The combination of raw materials to manufacture your product is likely to include naturally occurring pathogens. Traditional heat methods like roasting and baking will kill most pathogens. Remember, sterility is not the goal. The concern is that a manufacturer uses heat to achieve organoleptic qualities like color and texture, but the combination of time and temperature may not achieve safety. It is only with a validated process that safety is confirmed. If we model safety after what is required of food manufacturers by the Food and Drug Administration, validation of processes that control pathogens is required. In addition to traditional heat methods, non-thermal methods for control of pathogens includes irradiation and high pressure processing and are appropriate for highly priced goods, e.g. juice. Killing is achieved in the manufacturing environment and on processing equipment surfaces after cleaning and by sanitizing.

If you have done everything reasonable to stop microorganisms from getting in the product and you have a validated step to kill pathogens, you may still have spoilage microorganisms in the product. It is important that all pathogens have been eliminated. Examples of pathogens include Salmonella, pathogenic Escherichia coli, also called Shiga toxin-producing E. coli (STEC) and Listeria monocytogenes. These three common pathogens are easily destroyed by proper heat methods. Despite steps taken to kill pathogens, it is theoretically possible a pathogen is reintroduced after the kill step and before packaging is sealed at very low numbers in the product. Doctors do not know how many cells are required for a consumer to get ill, and the immunocompromised consumer is more susceptible to illness. Lab methods for the three pathogens mentioned are designed to detect very low cell numbers. Packaging and control of growth factors will stop pathogens from growing in the product, if present.

Control the growth of microorganisms

These growth factors will control the growth of pathogens, and you can use the factors to control spoilage microbes as well. To grow, microbes need the same things we do: a comfortable temperature, water, nutrients (food), oxygen, and a comfortable level of acid. In the lab, we want to find the pathogen, so we optimize these factors for growth. When you control growth in your product, one hurdle may be enough to stop growth; sometimes multiple hurdles are needed in combination. Bacteria, yeast, and mold are present in all environments. They are at the bottom of the ocean under pressure. They are in hot springs at the temperature of boiling water. The diversity is immense. Luckily, we can focus on the growth factors for human pathogens, like Salmonella, pathogenic E. coli, and Listeria monocytogenes.

The petri dishes show sterilization effects of negative air ionization on a chamber aerosolized with Salmonella enteritidis. The left sample is untreated; the right, treated. Photo courtesy of USDA ARS & Ken Hammond

Temperature. Human pathogens prefer to grow at the temperature of the human body. In manufacture, keep the time a product is in the range of 40^oF to 140^oF as short as possible. You control pathogens when your product is at very hot or very cold temperatures. Once the product cools after a kill step in manufacturing, it is critical to not reintroduce a pathogen from the environment or personnel. Clean equipment and packaging play key roles in preventing re-contamination of the product.

Water. At high temperatures as in baking or roasting, there is killing, but there is also the removal of water. In the drying process that is not at high temperature, water is removed to stop the growth of mold. This one hurdle is all that is needed. Even before mold is controlled, bacterial and yeast growth will stop. Many cannabis candies are safe, because water is not available for pathogen growth. Packaging is key to keep moisture out of the product.

Nutrients. In general, nutrients are going to be available for pathogen growth and cannot be controlled. In most products nutrients cannot be removed, however, recipes can be adjusted. Recipes for processed food add preservatives to control growth. In cannabis as in many plants, there may be natural compounds which act as preservatives.

Oxygen. With the great diversity of bacteria, there are bacteria that require the same oxygen we breathe, and mold only grows in oxygen. There are bacteria that only grow in the absence of oxygen, e.g. the bacteria responsible for botulism. And then there are the bacteria and yeast in between, growing with or without oxygen. Unfortunately, most human pathogens will grow with or without oxygen, but slowly without oxygen. The latter describes the growth of Salmonella, E. coli, and Listeria. While a package seals out air, the growth is very slow. Once a package is opened and the product is exposed to air, growth accelerates.

Acid. Fermented or acidified products have a higher level of acid than non-acid products; the acid acts as a natural preservative. The more acid, the more growth is inhibited. Generally, acid is a hurdle to growth, however and because of diversity, some bacteria prefer acid, like probiotics which are non-pathogenic. Some pathogens, like E. coli, have been found to grow in low acid foods, e.g. juice, even though the preference is for non-acidic environments.

Each facility is unique to its materials, people, equipment and product. A safe product is made by following Good Agricultural Practices for the cannabis, by following Good Manufacturing Practices and by suppressing pathogens by preventing them coming in, killing them and controlling their growth factors. Future articles will cover Hazard Analysis and Critical Control Points (HACCP) and food safety in more detail.

December 19, 2017

California Rolls Out Licensing For Cannabis Businesses

By Aaron G. Biros

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Last week, the Bureau of Cannabis Control issued the first licenses for California’s new market. The first license went to Moxie, a cannabis distribution company out of Lynwood.

The search feature for the list of licenses issued so far

As of the publication of this article, the Bureau, the state authority tasked with leading the regulation of the industry, has issued 43 temporary licenses. So far, four laboratories have received licenses, along with a number of retailers, distributors, microbusinesses in both medical and adult-use markets.

The labs to receive their temporary licenses so far are pH Solutions, Steep Hill Labs, Pure Analytics and ORCA Cannalytics. Judging by the number of temporary medical and adult-use licenses awarded so far, it appears the Bureau is trying to issue a similar amount for each sector, distributing the number of licenses between the two equitably.

You can find the list of licensees here, and search between the dates of 12/15/17 to 1/2/18 to get the most up-to-date list of licenses awarded. “Last week, we officially launched our online licensing system, and today we’re pleased to issue the first group of temporary licenses to cannabis businesses that fall under the Bureau’s jurisdiction,” says Lori Ajax, Bureau of Cannabis Control Chief. “We plan to issue many more before January 1.”

According to the press release, temporary licenses are only issued to applicants with prior local authorization in the form of a license or permit from the jurisdiction where the business is. Those licenses will become effective on January 1, 2018. The temporary licenses will work for 120 days, or May 1, 2018, after which businesses will need to have a permanent license to continue operating.

More than 1,900 users have registered with the Bureau’s online system, and more than 200 applications have been submitted, according to the press release.

The various regulatory bodies in California have worked diligently for months now to roll out proposed emergency regulations, setting strict requirements for manufacturers, growers, retailers and testing labs. Manufacturing regulations, including specific labeling, packaging and processing requirements, give a good snapshot of how regulators plan to move forward. Testing requirements could also be significantly firmer, with rules for documentation, sample sizes, sampling procedures, storage and transportation.

Yet when the adult-use sales become fully legal on January 1, 2018, those regulations will not be fully implemented.

Donald Land, a UC Davis chemistry professor and chief scientific consultant at Steep Hill Labs Inc., told The Associated Press, “Buyer beware.” There will be a six-month range where existing inventory will be allowed on the shelves, products that might not meet the standards of the new rules. So dispensaries will get half a year of sales before all products have to meet the new, stricter testing requirements.

November 29, 2017

Ask The Expert: Exploring Cannabis Laboratory Accreditation Part 4

By Aaron G. Biros

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In the first part of this series, we spoke with Michelle Bradac, senior accreditation officer at A2LA, to learn the basics of cannabis laboratory accreditation. In the second part, we sat down with Roger Brauninger, A2LA Biosafety Program manager, to learn why states are looking to lab accreditation in their regulations for the cannabis industry. In the third part, we heard from Michael DeGregorio, chief executive officer of Konocti Analytics, Inc., discussing method development in the cannabis testing industry and his experience with getting accredited.

In the fourth and final part of this series, we sit down with Susan Audino, Ph.D., an A2LA lead assessor and instructor, laboratory consultant and board member for the Center for Research on Environmental Medicine in Maryland. Dr. Audino will share some insights into method validation and the most technical aspects of laboratory accreditation.

Susan Audino obtained her Ph.D. in Chemistry with an analytical chemistry major, physical and biochemistry minor areas. She currently owns and operates a consulting firm to service chemical and biological laboratories. Susan has been studying the chemistry and applications of cannabinoids and provides scientific and technical guidance to cannabis dispensaries, testing laboratories and medical personnel. Dr. Audino’s interest most directly involves cannabis consumer safety and protection, and promotes active research towards the development of official test methods specifically for the cannabis industry, and to advocate appropriate clinical research. In addition to serving on Expert Review Panels, she is also chairing the first Cannabis Advisory Panel and working group with AOAC International, is a member of the Executive Committee of the ASTM Cannabis Section and has consulted to numerous cannabis laboratories and state regulatory bodies.

CannabisIndustryJournal: What are the some of the most significant technical issues facing an accreditation body when assessing a cannabis-testing laboratory?

Susan: From the AB perspective, there needs to be a high level of expertise to evaluate the merits and scientific soundness of laboratory-developed analytical test methods. Because there are presently no standard or consensus test methods available, laboratories are required to develop their own methods, which need to be valid. Validating methods require a rigorous series of tests and statistical analyses to ensure the correctness and reliability of the laboratory’s product, which is– the test report.

CIJ: When is method validation required and how does this differ from system suitability?

Susan: Method validation is required whenever the laboratory modifies a currently accepted consensus or standard test method, or when the laboratory develops its own method. Method validation is characterized by a series of analytical performance criteria including determinations of accuracy, precision, linearity, specification, limit of detection, and limit of quantitation. The determination of system suitability requires a series of deliberate variations of parameters to ensure the complete system, that is all instrument(s) as well as the analytical method, is maintained throughout the entire analytical process. Traditionally, method validation has been referred to as “ruggedness” and system suitability as “robustness.”

CIJ: What are the most important aspects of method validation that must be taken into account?

Susan: In keeping with the FDA guidelines and other accepted criteria, I tend to recommend the International Conference on Harmonization (ICH), particularly Q 2A, which is a widely recognized program that discusses the pertinent characteristics of method validation. This include: method specification, linearity, range, accuracy, and precision (e.g., repeatability, intermediate precision, reproducibility). As mentioned earlier, system suitability is also a critical element and although related to method validation, does require its own protocol.

CIJ: What three areas do you see the laboratory having the hardest time with in preparing for accreditation?

Susan: My responses to this question assume the laboratory employs appropriate instruments to perform the necessary analyses, and that the laboratory employs personnel with experience and knowledge appropriate to develop test methods and interpret test results.

By and large, method validation that is not appropriate to the scope of their intended work. Driving this is an overall lack of information about method validation. Oftentimes there is an assumption that multiple recoveries of CRMs constitute “validation”. While it may be one element, this only demonstrates the instrument’s suitability. My recommendation is to utilize any one of a number of good single laboratory validation protocols. Options include, but are not limited to AOAC International, American Chemical Society, ASTM, and ICH protocols.
Second is the lack of statistically sound sampling protocols for those laboratories that are mandated by their governing states to go to the field to sample the product from required batches. Sampling protocols needs to address the heterogeneity of the plant, defining the batch, and determining/collecting a sample of sufficient quantity that will be both large enough and representative of the population, and to provide the laboratory an adequate amount from which to sub-sample.
Third, sample preparation. This is somewhat intertwined with my previous point. Once an appropriate sample has been collected, preparation must be relevant to the appropriate technology and assay. It is unlikely that a laboratory can perform a single preparation that is amenable to comprehensive testing.

November 20, 2017

California Releases Proposed Emergency Regulations

By Aaron G. Biros

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Last week, the California Bureau of Cannabis Control released their proposed emergency regulations for the industry. The Bureau, the government agency tasked with regulating California’s cannabis industry, announced the proposed emergency regulations ahead of the highly anticipated January 2018 start date.

The Bureau also published helpful fact sheets and overview documents, providing a good snapshot of the major requirements for different types of licenses. Here are some of the key takeaways:

Temporary licenses will allow businesses to operate for 120 days while their annual license application is being processed. Not surprisingly, local jurisdictions have considerable autonomy. Getting a license seems to be contingent on first getting local approval to operate. According to Josh Drayton, communications and outreach director at the California Cannabis Industry Association (CCIA), working with local governments will be crucial to making progress. “Now that the Brown Administration has created the framework for medical and adult use cannabis, the main challenge we face as an industry is getting local municipalities to move forward with regulations,” says Drayton. “California has a dual licensing process which means that cannabis operators must receive a local permit/license/authorization before being able to apply for a state license. A majority of California cities and counties have yet to finalize their regulations which will delay state licensing.”

The initial reactions to these proposed regulations seem positive, given that this is a culmination of efforts over several years. “The California Cannabis Industry Association welcomes the release of the emergency regulations,” says Drayton. “These regulations represent years of hard work and collaboration between the administration, the regulating departments, and the cannabis industry.”

License Distinctions

A-type licenses are for businesses in the adult-use market, while M-type licenses are for the medical market. Laboratory licenses don’t have this distinction, as they can test both medical and adult-use products.

The record keeping and security requirements seem relatively straightforward, requiring normal surveillance measures like 24-hour video, commercial-grade locks and alarm systems. The rules also lay out guidelines for disposing of waste, including securing it on the premises and not selling it.

Distributors

Distributor licenses appear to have a number of compliance documentation requirements, such as arranging for all product testing, quality assurance and packaging and label accuracy. “Cannabis and cannabis products must pass through a distributor prior to being sold to customers at a retail establishment,” reads the overview the Bureau published. There is also a transport-only distributor license option. Those regulations appear to be more comprehensive than others, with a number of regulations pertaining to appropriate transportation and security measures.

Everything has to be packaged before it gets to retail; Retailers are not allowed to package or label cannabis products on premises. Microbusiness licenses will be available, which should be an exciting new development to follow as the market matures.

Labs

The state will require ISO 17025 accreditation for testing labs. A provisional license is required for a lab to operate in the short term, expiring after 12 months. Laboratory personnel are required to go in the field and do the sampling. Documentation requirements, sample sizes, sampling procedures and storage and transportation rules are also laid out.

Testing labs are required to test for cannabinoids, foreign material, heavy metals, microbial impurities, mycotoxins, moisture content and water activity, residual pesticides, residual solvents and processing chemicals and terpenoids (terpenes). Infused and edible products are required to be tested for homogeneity in THC and CBD concentrations as well. Drayton and the CCIA welcome these new testing regulations, hoping it might improve overall public safety. “We believe that these regulations will address public health issues by mandating the testing of all cannabis products,” says Drayton. “The evolution of the cannabis industry will continue, and we will continue to advocate for good policy that creates solutions for the problems that arise. I believe that we will be visiting and revisiting cannabis regulations for many years to come.”

Certificates of analysis (COA) will be required, showing whether a batch passes or fails testing requirements. Harvest batches that fail testing can be processed for remediation. “Testing laboratories are required to develop and implement a quality assurance program that is sufficient to ensure the reliability and validity of the analytical data produced by the laboratory,” reads the statement on QA and QC.

The Bureau, at the end of their regulatory overview document, lays out some possible enforcement actions, disciplinary actions and citations that could come from noncompliance. “These emergency regulations create a framework for both medical and adult use consumers,” says Drayton. “January 1, 2018 will be the first date that adults 21 years and older will be able to purchase cannabis without a medical card.”

In the coming weeks, we’ll be breaking down and analyzing the other proposed emergency regulations that the state released. Stay tuned for a breakdown of the California Department of Food & Agriculture (CDFA) regulations on cannabis cultivation, as well as The California Department of Public Health (CDPH) cannabis manufacturing regulations.

November 20, 2017

Steep Hill Expands To Oregon

By Aaron G. Biros

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Last week, Steep Hill announced they are expanding into Oregon with a laboratory in Portland. According to the press release, the company has licensed its testing technology to Dr. Carl Balog, a renowned pain and addiction physician.

Steep Hill has expanded significantly over the past year, including new laboratories in Pennsylvania, Maryland, Washington D.C. and Hawaii, among other states. The Berkeley-based company works in lab testing, research and development, licensing, genetics and remote testing. In 2008, Steep Hill opened the first-ever commercial cannabis-testing laboratory in the country.

Jmîchaeĺe Keller, president and chief executive officer of Steep Hill, says this is a development that will help them better understand cannabis chemistry and its medical applications. “We are pleased to announce our expansion into Oregon and especially pleased to partner with Dr. Balog, a physician who brings years of pain and addiction experience to the Steep Hill body of expertise,” says Keller. “In addition, Dr. Balog plans to use his specialized knowledge to aid Steep Hill’s research and development efforts to broaden our understanding of cannabis chemistry and to explore its wider medical applications. In partnering with Dr. Balog, we hope that Steep Hill will be able to help physicians around the United States to curb the opioid epidemic by offering Steep Hill Verified™ medicinal cannabis as an alternative to a crisis that plagues this country.”

Examination of cannabis prior to testing- credit Steep Hill Labs, Inc.

Dr. Balog, now owner and medical director of Steep Hill Oregon, says medical cannabis could be an excellent harm reduction tool, and hints at it being a possible tool in the opioid crisis. “I deal with the consequences of the opioid epidemic on a daily basis as a pain and addiction specialist,” says Dr. Balog. “The growing trend of using cannabis products as an alternative to opioids highlights the need for regulated testing. Because of the variability of marijuana preparations, testing ensures that scientific rigor is applied in a standardized way. I am dedicated to ensuring that patients have access to safe, tested cannabis, free from contaminants and to verified labels that can be trusted for their content.”

They expect Steep Hill Oregon to be open for business in the second quarter of 2018.

November 10, 2017

Using Cloud-Based LIMS To Improve Efficiency In Cannabis Labs

By Shonali Paul

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Cannabis testing laboratories around the country are expanding quickly, taking on new clients and growing their business incrementally. Many of these labs are receiving a large number of test requests from growers for potency testing, terpene profiling, pesticide screening, residual solvent screening, heavy metal testing, microbial analysis and even genetic testing. To keep pace with the number of test requests received, efficient data, sample and test management is imperative.

Considering the magnitude of cannabis testing, data management using spreadsheets is a serious impediment to quality assurance. Data being recorded in spreadsheets is error-prone and difficult to manage. Furthermore, using spreadsheets does not allow labs to adhere to regulatory guidelines that demand strict accounting for every gram of the sample, right from reception, consumption for testing, to disposal.

Log samples, keep track of Chain of Custody(CoC), track samples from initial location in the lab through disposal by recording location, custodians and other metadata

To overcome such data management challenges and improve the operational efficiency of cannabis testing laboratories, a Laboratory Information Management System (LIMS) plays a significant role. LIMS are much more capable than spreadsheets and paper-based tools for managing analytical and operational activities. LIMS enhances the productivity and quality by eliminating the manual data entry. With its built-in audit trail capability, LIMS helps labs adhere to regulatory standards.

LIMS can provide companies with a method to manage samples, records and test results, and ensures regulatory compliance by increasing traceability. LIMS can also be integrated with other lab instrumentation and enterprise systems, enabling easier transmission of information across the lab and the organization, reducing manual efforts and improving decision-making.

Account for the entire quantity of sample received, used and disposed

Multiple resources are also available to assist labs in preparing for quality assurance and accreditation, LIMS being one of them. LIMS can help cannabis labs with instrument integration, and automate reporting to help improve efficiencies and reduce errors. LIMS, such as CloudLIMS Lite, a cloud-based LIMS, automates cannabis-testing workflows right from sample collection, data recording, managing test chain of custody, sample weight accounting to report generation. With data security and audit trails, a LIMS provides traceable documentary evidence required to achieve ISO 17025 accreditation for highly regulated labs. Above all, cloud-enabled systems are often low in the total cost of acquisition, have maintenance outsourced, and are scalable to help meet the ever-changing business and regulatory compliance needs.

Incorporate all tests, instruments, sample information and result data (etc.) in one place

Cloud-based products are secure, easy to deploy and scalable. A cloud product is typically hosted on a server with a guaranteed uptime of 99.5%, allowing for a reliable system, accessible 24×7. Cloud-based LIMS have automatic data backup mechanism that allow for quick turnarounds in case of a server failure or in the eventuality of a natural disaster.

With LIMS in place, cannabis labs can manage sample and requisition-centric records, track sample quantity and location, integrate the test data, and provide online reports to clients. This in turn, reduces the turnaround time for testing and improves the operational efficiency. Besides, audit trail of each and every activity performed by the lab personnel is recorded in the system to ensure that the lab follows regulatory compliance.

Editor’s Note: This is a condensed version of a poster that was submitted and displayed at this year’s Cannabis Science Conference in Portland, Oregon. The authors of the original poster are Arun Apte, Stephen Goldman, Aditi Gade and Shonali Paul.