Tag Archives: quality control

Meet Looming Federal Cannabis Regulatory Compliance Management with Automation & Confidence

By Steven Burton
1 Comment

Federal regulation of the cannabis and hemp sectors is coming sooner rather than later — and this is mostly good news for cannabis businesses and consumers. But cannabis producers already struggling to meet complex and ever-changing local regulations (where they exist) will be facing a new set of challenges with another level of regulatory oversight and compliance.

Navigating multi-jurisdictional regulatory compliance management requirements is near-impossible with legacy manual systems. That’s why it’s time to leverage the right enterprise resource planning (ERP) system, so that you and your team can meet these compliance management complexities with confidence and ease. Whether you manufacture flower, edibles, beverages, supplements or other dispensary products, here’s what you need to know to stay agile and profitable as more changes loom.

Federal Legalization is Coming

To date, there are 18 states with adult use cannabis markets, 37 with medical cannabis programs, and an additional 13 that have some level of decriminalization. At the federal level, there have already been several attempts at cannabis law reform, with even more on the table in the coming year.

One of the most promising is the Republican-led States Reform Act, filed in November 2021. The central tenant of this proposed legislation is to remove cannabis and cannabinoids from listing as a Schedule 1 Drug under the Controlled Substances Act.

Importantly, if this law passes, it would allow individual states to pursue their own cannabis policies and remove the current risks companies face when going against current federal anti-cannabis scheduling.

The States Reform Act also proposes a three percent federal tax on all cannabis sales and that all cannabis sales fall under the ​​Alcohol and Tobacco Tax and Trade Bureau’s (TTB’s) control. The States Reform Act would — finally — guide the regulation of hemp-derived products through the Food and Drug Administration (FDA).

US Senate Majority Leader Chuck Schumer has also been working on another reform bill, specifically the Cannabis Administration and Opportunity Act (CAOA), which he plans to introduce in April 2022 to further emphasize the criminal justice aspects of legal reform in the context of the War on Drugs.

While the government’s track record on cannabis regulatory reform hasn’t been as progressive as many would like, at this point there is widespread public support and proposed bills from both sides of the aisle. As a result, the US may finally see some movement on cannabis law reform in the very near future.

How to Prepare for Federal Regulatory Compliance Management

With federal regulation looming, it’s time for licensed producers to elevate their internal systems. Whether you work with tetrahydrocannabinol (THC) or cannabidiol (CBD), the regulatory protocols in an already complex marketplace are going to change.

This is especially paramount for those producing cannabis or hemp beverages, edibles and supplements. You will need comprehensive and efficient systems to facilitate this transition. An ERP should reduce compliance headaches and ensure your business is ready to scale when a national marketplace launches.

Automate Data Gathering

It is no longer cost effective to manage seed-to-sale traceability with manual data capture. With the thousands, if not tens of thousands, of data points required at most commercial facilities on a routine basis, data logging is by far the best way to start compliance automation.

Automated ERP systems, which capture essential information across your entire operation, ensure access to real-time data for forecasting, accounting, regulatory compliance reporting and traceability. That means using software that captures and logs intel from across your organization about quality control, inventory and traceability, all without arduous manual input.

The best and most successful ERP systems should be used by all employees to collect data, from sorters/pickers to fork lift drivers to supervisors to senior management. For this to happen easily, the solution must be accessible and user friendly for all employees. ERP systems that can be easily integrated with tablets and smartphones (as well as IoT devices) reduce the need for expensive terminals on the production floor and make data collection a straightforward part of daily operations.

Build Systems to Facilitate Growth from the Start

A rigid ERP system that can’t grow with you is not a smart long-term investment. An adaptable multi-platform system evolves with your company and constantly changing regulatory compliance requirements. A solution that provides access to the entire facility, instead of being limited to individual users, ensures that growing teams can easily contribute to data quality from the plant floor all the way up to the executive office for actionable insights.

Markets are opening up across the country and quite soon, many companies will be looking to expand their operations nationally. As a result, you’ll need systems that can scale, cover additional facilities, keep up with increased production, and even work across different jurisdictions.

Having instant access to detailed operational information delivers greater business oversight at the micro and macro levels – insight that is crucial for expansion, profitability, and cost-cutting measures. Companies with the right systems in place will effectively manage the resulting federal complexities to deliver on regulatory expectations and capture a competitive market share.

Leverage Regulatory Frameworks and Technology from the Food Industry

The Canadian example demonstrates clearly that the regulatory frameworks from the food and beverage industry are the most applicable to the cannabis sector – more so than for pharmaceuticals, nutraceuticals or alcohol. This is most obvious in lucrative value-added markets like edibles and extracts, which are actually also food products.

Issues like dosage standardization, controlling common hazards, managing traceability chains and inventory, and introducing quality standards (including third party certifications like organic and SQF) are all crossovers from the food industry.

Just as the compliance automation wave has hit the food industry in recent years, manufacturers of infused products and extracts can then use the same technology to reduce safety and quality control costs as well as documentation and administrative costs. The lesson? Cannabis industry leaders don’t need to totally reinvent the wheel.

Cannabis Producers Need an ERP System Tailored to Their Needs

In Canada, cannabis manufacturers have learned all too well what a few little mistakes can do to reputation and profitability. MJBiz Daily reported in 2021 that the Canadian government had issued more than CDN $1.3 million (USD $1 million) in fines since legalization. That’s a lot of regulatory compliance issues. Considering there are nearly 500 compliance fields to fill out for monthly reporting, mistakes are difficult to avoid, especially if you rely on a manual system.

FDAlogoThe story is similar in the United States. State regulatory compliance management requirements are complex and arduous for individual companies and employees. When federal regulation does come, US-based producers will very likely face even more strenuous reporting requirements to multiple jurisdictions.

Cannabis companies will need a data-driven system in place to align with the FDA’s Cannabis-Derived Products Data Acceleration Plan. Finding food safety and traceability software that makes reporting easier, automatic, and less prone to human error is paramount to success. As you prepare for the looming federal legislation, look for an ERP system that covers all the bases, including one that:

  • Improves Market Agility: Expedites opening new facilities in new markets as they come online
  • Evolves with Regulatory Changes: Facilitates the transition from unregulated markets into federally regulated ones
  • Automates Reporting: Protects you from regulatory compliance management bumbles stemming from manual input and human error
  • Reduces Workload: Optimizes workflow and reduces labor costs associated with manual input
  • Is Comprehensive: Covers all bases, including food safety, quality control, traceability, production management, and even occupational health and safety

If you aren’t automating the capture of essential information across the entire operation, you won’t be prepared for the regulatory burdens likely to come with federal cannabis legislation. To stay compliant and on top of what will likely be an incredibly competitive marketplace, you are going to need real-time data — data that will provide precise seed-to-sale traceability, product recall capability, and reporting.

Digitizing safety, traceability and complex production management through one state-of-the-art ERP system allows cannabis companies to reap the rewards of data-driven, automation technology almost immediately without the significant capital expenditure on large-scale equipment or robotics. From there, navigating regulatory complexity becomes not only streamlined and operationalized, but an actual market advantage for future growth.

Flooring Tips for Cannabis Growing Facilities

By Sophia Daukus
5 Comments

In the burgeoning cannabis market, grow facilities are facing more and more competition every day. New indoor cultivation enterprises are often being set up in formerly vacant industrial buildings and commercial spaces, while in other cases, companies are planning and constructing new grow facilities from the ground up. For all these establishments, continually lowering production costs while supplying the highest possible quality in ever-increasing yields is the way forward.

Whether in existing or new structures, concrete floors are ubiquitous throughout the majority of cannabis growing facilities. With the right treatment, these indoor concrete traffic surfaces can greatly contribute to a company achieving its operational objectives. Alternatively, insufficiently protected concrete floors can create annoying and costly barriers to accomplishing company goals.

Challenges in Cannabis Grow Facility Construction

As with any emergent industry, mainstream acceptance and market growth is bringing regulation to cannabis cultivation. Local governments are paying more attention to how cannabis growing facilities are constructed and operated. In addition to the standard business matters of building safety, employee working conditions and tax contributions, elected officials are increasingly under pressure from constituents to analyze the overall effect of grow facilities on their communities at large.

High consumption of energy for grow room lights and high water usage are just part of the equation. The temperature and humidity needs of a grow facility can be similar to that of an indoor swimming pool environment. While warmth and moisture are ideal for cannabis growth, they also provide the ideal conditions for the growth and proliferation of fungi and other undesirable microorganisms. Therefore, to help preserve plant health in the moist indoor climate, fumigation often comes into play.

Carbon dioxide (CO2) enrichment of grow room air, a common practice proven to increase crop yields, presents another set of safety and health considerations in dense urban environments.

Adding to these challenges, many cannabis grow facilities are producing plants destined for either pharmacological or nutritional use. This in itself demands scrutiny by regulators for the sake of the consuming public.

As a result, grow room managers and owners must stay informed about the evolution of the industry in terms of local and federal agency regulations concerning their facilities, their overall operation and their products.

Bare Concrete Floors in Grow Rooms

As a foundational construction material, concrete continues to lead the way in commercial and industrial construction. Despite the many advantages of concrete floors, when left unprotected they can present significant challenges specific to cannabis grow rooms.

  • Untreated, bare concrete is naturally porous, easily absorbing liquids and environmental moisture. Substances found in grow rooms, such as fertilizers, fungicides and other chemicals, can leach through the porous concrete floor slab into the soil and ground water. Whether organic or synthetic, concentrations of such substances can be highly detrimental to the surrounding environment.
  • Whether in an existing or newly constructed facility, it is not uncommon for the under-slab vapor barrier to be compromised during construction. When this occurs, moisture from the soil beneath the floor slab can enter the concrete and move osmotically upward, creating a phenomenon known as Moisture Vapor Transmission (MVT). The resulting moisture and moisture vapor tends to become ever more alkaline as it rises upward through the concrete slab. MVT can result in blistering, bubbles and other damage to floor coverings.
  • The warm temperatures, regular watering of plants and high relative humidity maintained within many grow rooms can contribute to a weakening of the structural integrity of unprotected grow room slabs.
  • Within the confined space of a grow room, the warm, moist air invites microbe proliferation. Food and pharmaceutical plants are high on the priority list when it comes to facility hygiene levels, as demanded by code.

Public health guidelines for cannabis cultivation facilities in various parts of the country are increasingly mirroring those of food processing. Typical requirements include having smooth, durable, non-absorbent floor surfaces that are easily cleaned and in good repair, possessing proper floor slope towards a sanitary floor drain, with no puddling, as well as an integral floor-to-wall cove base. These directives cannot be met with bare concrete alone.

Optimal Grow Room Flooring Performance

In some locations, cannabis growing facilities are already subject to strict building codes and regulations. This will no doubt be spreading to other regions in the near future. For example, the Public Health Agency of Los Angeles County publishes construction guidelines to ensure cannabis facility floors meet standards mirroring the food processing and pharmaceutical manufacturing industries, where sanitation, facility hygiene and safety are paramount. In these types of facilities, bare, unprotected concrete floor slabs are not allowed as a general rule, due to the material’s innate porosity and absorbency.

Flooring in grow rooms, like in their food and pharma industry counterparts, should optimally:

  1. Provide a monolithic and virtually seamless surface to help eliminate crevices, grout lines and other dark, damp locations where soil and pathogens tend to hide
  2. Be impervious and non-porous, providing a surface that can isolate toxic materials on the surface for proper clean-up where needed
  3. Enable correction or improvement of the floor slope for proper drainage, with no low spots to help avoid puddling
  4. Be installed with integral floor-to-wall cove options for easier wash-down and sanitizing
  5. Have the strength and thermal shock resistance, plus the tenacious bond, to undergo steam-cleaning and/or hot power washing, where needed
  6. Enable seamless, continuous surface installation over concrete curbs and containment areas
  7. Offer antimicrobial options for highly sensitive locations
  8. Demonstrate high compressive strength and impact resistance for durability under heavy loads
  1. Display excellent abrasion resistance, allowing the system to perform under grueling daily wear-and-tear
  2. Present customizable slip-resistance options that can be balanced with easy clean-ability
  3. Facilitate the use of floor safety markings, such as color-coded traffic and work area designations
  1. Be formulated with low odor, low-VOC chemistries that meet all EPA and similar regulations
  2. Be able to contribute LEED Green Building Credits, where desired
  3. Include options for refurbishing old or damaged concrete surfaces to allow reuse of existing facility resources, as opposed to having to be demolished, thus unnecessarily contributing to landfill waste
  4. Withstand and perform in continually damp grow room conditions, without degrading
  5. Be compliant with FDA, USDA, EPA, ADA, OSHA, as well as local regulations and/or guidelines
  6. Include MVT mitigating solutions where Moisture Vapor Transmission site issues are present
  7. Provide waterproofing underlayment options for multi-story facilities
  8. Demonstrate excellent resistance to a broad range of chemicals, fertilizers and extreme pH substances

Finding an affordable floor system with all the above features may seem like a tall order. Luckily, innovative manufacturers now offer cannabis facility flooring that meets sanitation, regulatory compliancy, durability and budgetary needs of growers.

Resinous Flooring Value for Cannabis Facilities

Choosing the right floor solutions for a given cultivation facility may be one of the most important decisions an owner or manager makes. Since floors are present throughout the structure, poor selection and compromised protection of concrete slabs can end up wreaking havoc with profits and yields over time.

Few facilities can afford the inconvenience and expense of an otherwise unnecessary floor repair or replacement. Having to suddenly move cumbersome plant beds and heavy pots in order to give workers access to the floor area can be headache. In addition, the unscheduled downtime and overall juggling of resources that invariably must take place make a strong case for investing in optimal grow room flooring from the start.

An excellent long-term value, professional-grade resinous floor systems present cannabis growers with a unique set of solutions for cultivation rooms. Not only does this type of flooring offer all the desirable features listed above, but also furnish a host of added benefits to grow room operations, including:

Very High Gloss Finish

  • Highly reflective floor surfaces enable light entering the space from overhead to bounce back upward, exposing the underside of leaves to the light and potentially increasing yields
  • Exceptionally high gloss floor finishes in light colors help make the most of your existing lighting sources, significantly increasing room illumination
  • Achieving greater illumination without adding fixtures helps reduce energy consumption and associated costs

Virtually Seamless Surface

  • Fluid-applied resin-based flooring provides an impermeable, monolithic surface that is exceptionally easy to clean and maintain
  • The virtually seamless finish of resinous coated floors greatly reduces the number of locations for soil, pathogens and microbes to gather
  • Resinous floors, by incorporating integral cove bases to eliminate ninety degree angles, correcting floor slope to eliminate puddling, and allowing for a virtually seamless surface, provide an optimally sanitary flooring solution

Outstanding Moisture Tolerance

  • Designed specifically for use in wet industrial environments, cementitious urethane flooring is a top choice for humid grow rooms
  • Also called “urethane mortar”, this type of floor can help mitigate certain undesirable site conditions, such as Moisture Vapor Transmission (MVT)

Chemical, Acid and Alkali Resistance

  • Whether organic or synthetic, many soil enhancers and substances used to eradicate undesirable fungi and pests can damage concrete and shorten the usable life of foundational slabs
  • Protecting concrete slabs with monolithic, non-absorbent and appropriately chemical resistant coating systems allows concrete to perform as designed, for as long as intended
  • A proper barrier coating on the floor allows spilled or sprayed substances to be properly cleaned up and disposed of, rather than allowing the liquids to seep through the porous slab, and into the surrounding natural environment

Added Safety

  • Resinous coating systems’ slip-resistance is completely customizable at the time of installation, enabling growers to request more traction in pedestrian walkways and less slip-resistance under raised beds.
  • Epoxy, urethane and polyaspartic resinous flooring systems accommodate the installation of safety and line markings, as well as varying colors to delineate specific work areas
  • The antimicrobial flooring options available from some manufacturers offer further hygiene support in highly sensitive facilities
  • Today’s industrial resinous floor coatings from reputable suppliers are very low to zero V.O.C. and compliant with EPA and other environmental regulations

Resinous coating systems provide ideal value to informed growers who require durable, reliable and long-lasting high performance flooring for their facilities.

Support from the Ground Up

From incredible medical advances to high tensile fiber in construction materials, the expanding cannabis industry is bringing exciting opportunities to many areas of the economy. As more and more growers enter the market, so increases the pressure to compete.

By choosing light reflective, seamless and moisture tolerant resinous flooring that meets regulatory guidelines for grow rooms, managers can help reduce their overhead costs on multiple fronts — and get a jump on the competition.

Cannabusiness Sustainability

Climate Change Drives Cannabis Indoors

By Carl Silverberg
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This is not a discussion of climate change, it’s a discussion of the impact of weather on the agriculture industry. The question for the cannabis & hemp industry, and basically the entire specialty crop industry, is what will be the impact? According to the U.S. National Climate Assessment, “Climate disruptions to agriculture have been increasing and are projected to become more severe over this century.” I’m sure that’s not much of a shock to anyone who owns a farm, orchard or greenhouse.

Every national newspaper for the past two weeks has published at least one article a day about the flooding in the Midwest, while industry newsletters and blogs have contained more in-depth stories. The question is, what can agriculture professionals do to mitigate these problems?

Relying on state and national legislators, especially heading into a presidential election year is likely to be frustrating and unrewarding. Governments are excellent at reacting to disasters and not so good at preventing them. In short, if we depend on government to take the lead it’s going to be a long wait.Instead, many farmers are looking at the future costs of outdoor farming and concluding that it’s simply cheaper, more efficient and manageable to farm indoors.

Instead, many farmers are looking at the future costs of outdoor farming and concluding that it’s simply cheaper, more efficient and manageable to farm indoors. Gone are the days when people grew hemp and cannabis indoors in an effort to hide from the police. Pineapple Express was a funny movie but not realistic in today’s environment.

Today’s hemp and cannabis growers are every bit as tech savvy as any other consumer-oriented business and one could argue that given the age of their customers (Statista puts usage by 18-49-year-olds at 40%), distributors must be even more tech savvy to compete effectively. Some estimates put the current split of cultivation at about one-third indoors/two-thirds outdoors. To date, the indoor focus has been on efficiency, quality and basically waiting for regulators to allow shipping across state lines.

A major driver in the indoors/outdoors equation is that as the weather becomes more unfriendly and unpredictable, VC’s are factoring climate disruption into their financial projections. When corn prices drop because of export tariffs, politicians lift the ban on using Ethanol during the summer months. It’s going to be a while before we see vehicles running on a combination of gasoline and CBD.

Leaving aside the case that can be made for efficiency, quality control and tracking of crops, climate change alone is going to force many growers to reassess whether they want to move indoors. And, it’s certainly going to weigh heavily in the plans of growers who are about to launch a cannabis or hemp business. Recently, one investment banker put it to me this way: greenhouses are the ultimate hedge against the weather.

The Need for Standardization in Medical Cannabis Testing

By Andrew James
2 Comments

There has been a move towards the legalization of cannabis for medical and/or recreational use across many countries and US states in recent years, leading to greater demand for accurate potency and safety testing. Despite this, there are currently no standardized regulations between states or countries for quality control including content, composition, adulterants, potency or levels of toxic residues. As such, in many cases where regulations are in place, testing is generally carried out at a small number of approved independent testing laboratories.

The need for self-regulation has led to the growth of portable gas chromatography (GC) being used in the field of cannabis testing.This lack of clarity makes it difficult for consumers to make informed decisions about what they are purchasing, an issue which could be damaging to the industry’s changing reputation. As it stands, producers of cannabis and cannabis-derived products can supply goods with potentially harmful contaminants such as fungi or pesticide residues, which are potentially threatening to human health. Most cannabis products sold legally in the US are required to be tested and labelled for THC, the chemical responsible for most of cannabis’s psychoactive effects. A US study found that as few as 20% of recreational cannabis products are accurately labelled with only 17% of products reviewed accurately labelled for THC content (i.e. within 10% of the labeled value). It also found 23% were under labelled, and 60% were over labelled.

If cannabis were to be categorized as a regulated pharmaceutical drug, it would be rigorously tested to comply with stringent rules and regulations regarding quality and safety of the product, as are all other drugs. However, as there is currently no centralized regulatory body that oversees this, the responsibility of quality assurance falls to the grower, manufacturer and sometimes the consumer.

The Need for Cannabis Analysis

The most common requirement when testing cannabis is positive identification and quantification of the total THC:CBD ratio. In a highly competitive marketplace, this information is important, as cannabis consumers tend to equate THC levels with price. In many instances, lower THC products are cheaper and higher THC concentrations make products more expensive. Without robust systems in place for sufficient testing, this information cannot be accurately determined, meaning the customer often cannot make an informed decision.

Pesticide use is surprisingly common in the cannabis cultivation industry

In addition to potency testing, one of the core issues facing the industry and by extension, the end consumer, is the prevalence of pesticides in cannabis products. In the Netherlands, the Ministry of Environment and Health reported that over 90% of cannabis plants tested had pesticides on them. While steps have been taken to tackle this, the lack of cohesion in testing standards combined with the onus on individual labs to carry out testing, has led to some issues within the industry.

Many individual retailers in the U.S. and internationally are self-testing for impurities such as pesticides, heavy metals and microbials. While there is a clear need for standard testing across all locations, the need for self-regulation at present has led to the growth of portable gas chromatography (GC) being used in the field of cannabis testing.

Using GC as an analytical tool 

With the increased need for quality control and quality assurance in the largely unregulated cannabis industry, technology is now more accessible to smaller companies and to people with minimal laboratory experience. There are a range of cannabis testing packages available for smaller individual labs which offer more mobile testing with affordable packages. The lower entry price makes GC analysis affordable for more laboratories while still delivering reliable, high quality results.

Portable GC instruments can offer high quality potency testing, pesticide screening, terpene and flavor profiling, and residual solvents analysis. These instruments can give growers and processors an accurate result of cannabinoid percentages, a fundamental piece of information for growers and dispensaries. Systems can be configured for manual injection or a range of autosampler options can be added.

The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.

GC enables the rapid and accurate identification and quantification of the THC:CBD ratio. This is important for companies which are carrying out self-testing as it allows their customers to have assurances in the short term over the quality of their product, as well as reducing any potential risks to public health.

An example of this in practice is the use of GC by Dutch company Shamanics which carries out testing service for coffee shops in the Netherlands. The company conducts terpene analysis and potency testing to assure the quality of the products it supplies, with a portable GC, which offers the flexibility required without any established guidelines on testing in place.

When testing for potency using the GC, they look for total THC and CBD by converting the acidified versions of the cannabinoids into neutral forms within the heat of the GC injector. The process has flexibility which means that if they need to see both the acidified and neutral versions, they can do this by derivatizing the sample. The accuracy of this process is crucial to Shamanics and similar companies within the industry so that they can accurately judge the quality of a product, and relay this information to retailers and consumers.

The future of GC in standardized testing

While the growing availability of portable GC instruments and the increasing sophistication of individual labs means more companies are able to self-test products, there is still a significant hurdle to overcome in terms of standardising and regulating both the medical and recreational cannabis markets. Where regulation is brought in it should be consistent across states and countries and most importantly, it should be monitored and enforced. In the meantime, responsible producers are using the technology available to them to provide consumers with guarantees that their cannabis products are safe and of a high quality.

Stratos: Quality, Expansion & Growth in Multiple Markets

By Aaron G. Biros
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Jason Neely founded Stratos in 2014, when he and a small group of people left the pharmaceutical industry in search of a new endeavor in the cannabis marketplace. The concept was straightforward: Apply pharmaceutical methodologyof production to cannabis products. Back then, Stratos offered a range of THC-infused tablets in the Colorado market.

Brenda Verghese, vice president of research & development

Brenda Verghese, vice president of research & development, was one of five people on staff when Stratos launched. Now they have about 30 team members. Consumers were looking for a cannabis product that would be consistent and reliable every time, taking the guesswork out of infused products dosage. That’s where Brenda Verghese found her skillset useful.

Transitioning to the pharmaceutical industry right out of college, Verghese started her career as a chemist and worked her way up to the R&D business development sector. “I specializedin formulations and taking a product from concept to commercialization in the pharmaceutical space,” says Verghese. “Jason Neely approached me with the idea of a cannabis company and focusing on making products as effective and consistent as possible, so really bringing pharmaceutical science into the cannabis space. In the matter of 4 years we grew substantially, mainly focusing on the efficacy of products.”

Behind the scenes at packaging and labeling Image credit: Lucy Beaugard

Soon after the success of their THC products became apparent, Stratos launched a CBD line, quickly growing their portfolio to include things like tinctures and topicals as well. According to Verghese, they are hoping that what’s been established on the THC side of their business as far as reproducibility and consistency is something that consumers will also experience on the CBD side. “Quality and consistency have definitely driven our growth,” says Verghese. “That is what consumers appreciate most- the fact that every tablet, tincture or swipe of a topical product is going to be consistent and the same dose every time.” This is what speaks to their background in the pharmaceutical sciences, FDA regulation has taught the Stratos team to create really robust and consistent formulations.

Quality in manufacturing starts at the source for Stratos: their suppliers. They take a hard look at their supply of raw materials and active ingredients, making sure it meets their standards. “The supplier needs to allow us to do an initial audit and periodic audits,” says Verghese. “We require documentation to verify the purity and quality of oil. We also do internal testing upon receipt of the materials, verifying that the COAs [certificates of analysis] match their claims.”

Process validation in action at the Stratos facility
(image credit: Lucy Beaugard)

Verghese says maintaining that attention to detail as their company grows is crucial. They implement robust SOPs and in-process quality checks in addition to process testing. They test their products 5-6 times within one production batch. Much of that is thanks to Amy Davison, director of operations and compliance, and her 15 years of experience in quality and regulatory compliance in the pharmaceutical industry.

Back in August of 2018, Amy Davison wrote an article on safety and dosing accuracy for Cannabis Industry Journal. Take a look at this excerpt to get an idea of their quality controls:

Product testing alone cannot assess quality for an entire lot or batch of product; therefore, each step of the manufacturing process must be controlled through Good Manufacturing Practices (GMP). Process validation is an aspect of GMPs used by the pharmaceutical industry to create consistency in a product’s quality, safety and efficacy. There are three main stages to process validation: process design, process qualification and continued process verification. Implementing these stages ensures that quality, including dosing accuracy, is maintained for each manufactured batch of product.

Fast forward to today and Stratos is looking at expanding their CBD products line significantly. While their THC-infused products might have a stronger brand presence in Colorado, the CBD line offers substantial growth potential, given their ability to ship nationwide as well as online ordering. “We are always evaluating different markets and looking for what suits Stratos and our consumer base,”says Verghese.

A2LA Partners With ATACH

By Aaron G. Biros
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Last week, the American Association for Laboratory Accreditation (A2LA) and the American Trade Association for Cannabis and Hemp (ATACH) announced a new partnership agreement. This partnership is the first of its kind where a laboratory accreditation body and a cannabis trade organization work together under an MOU.

According to the press release, the two organizations hope to promote “foundational standards for quality control testing and regulatory guidelines that promote product safety.” Both organizations will advocate for the adoption of industry standards they deem appropriate for recreational and medical cannabis as well as hemp testing in the United States.

Michael Bronstein, executive director of ATACH, says there is an urgent need for open-source consensus standards and standard test methods for cannabis testing. “In an industry that lacks standard test methods and where testing is such a crucial part of the regulatory landscape, the need for open-source consensus standards is especially significant,” says Bronstein. “The development and adoption of standard test methods for cannabis testing is essential in ensuring consistency between laboratories, encouraging uniformity in state testing regulation, and providing a safe and consistent product to consumers.”

The press release also states that A2LA and ATACH seek to “develop regulation and adopt industry standards with goals of advancing and professionalizing the industry.”

Dr. Ed Askew
From The Lab

Quality Plans for Lab Services: Managing Risks as a Grower, Processor or Dispensary, Part 4

By Dr. Edward F. Askew
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Dr. Ed Askew

In the last three articles, I discussed the laboratory’s responses or defenses used to reply to your questions about laboratory results that place stress on the success of your business. The Quality Control (QC) results can cause this stress if they are not run correctly to answer the following questions:

  1. Are the laboratory results really true?
  2. Can the laboratory accurately analyze sample products like my sample?
  3. Can the laboratory reproduce the sample results for my type of sample?

Now let’s discuss the most important QC test that will protect your crop and business. That QC sample is the Matrix Sample. In the last article in this series, you were introduced to many QC samples. The Matrix Sample and Duplicate were some of them. Take a look back at Part 3 to familiarize yourself with the definitions.

The key factors of these QC sample types are:

  1. Your sample is used to determine if the analysis used by the laboratory can extract the analyte that is being reported back to you. This is performed by the following steps:
    1. Your sample is analyzed by the laboratory as received.
    2. Then a sub-sample of your sample is spiked with a known concentration of the analyte you are looking for (e.g. pesticides, bacteria, organic chemicals, etc.).
    3. The difference between the sample with and without a spike indicates whether the laboratory can even find the analyte of concern and whether the percent recovery is acceptable.
    4. Examples of failures are from my experiences:
      1. Laboratory 1 spiked a known amount of a pesticide into a wastewater matrix. (e.g. Silver into final treatment process water). The laboratory failed to recover any of the spiked silver. Therefore the laboratory results for these types of sample were not reporting any silver, but silver may be present. This is where laboratory results would be false negatives and the laboratory method may not work on the matrix (your sample) correctly. .
      2. Laboratory 2 ran an analysis for a toxic compound (e.g. Cyanide in final waste treatment discharge). A known amount of cyanide was spiked into a matrix sample and 4 times the actual concentration of that cyanide spike was recovered. This is where laboratory results would be called false positives and the laboratory method may not work on the matrix (your sample) correctly.
  2. Can the laboratory reproduce the results they reported to you?
    1. The laboratory needs to repeat the matrix spike analysis to provide duplicate results. Then a comparison of the results from the first matrix spike with its duplicate results will show if the laboratory can duplicate their test on your sample.
      1. If the original matrix spike result and the duplicate show good agreement (e.g. 20% relative percent difference or lower). Then you can be relatively sure that the result you obtained from the laboratory is true.
      2. But, if the original matrix spike result and the duplicate do not show good agreement (e.g. greater than 20% relative percent difference). Then you can be sure that the result you obtained from the laboratory is not true and you should question the laboratory’s competence.

Now, the question is why a laboratory would not perform these matrix spike and duplicate QC samples? Well, the following may apply:

  1. These matrix samples take too much time.
  2. These matrix samples add a cost that the laboratory cannot recover.
  3. These matrix samples are too difficult for the laboratory staff to perform.
  4. Most importantly: Matrix samples show the laboratory cannot perform the analyses correctly on the matrix.

So, what types of cannabis matrices are out there? Some examples include bud, leaf, oils, extracts and edibles. Those are some of the matrices and each one has their own testing requirements. So, what should you require from your laboratory?

  1. The laboratory must use your sample for both a matrix spike and a duplicate QC sample.
  2. The percent recovery of both the matrix spike and the duplicate will be between 80% and 120%. If either of the QC samples fail, then you should be notified immediately and the samples reanalyzed.
  3. If the relative percent difference between the matrix spike and the duplicate will be 20% or less. If the QC samples fail, then you should be notified immediately and the samples should be reanalyzed.

The impact of questionable laboratory results on your business with failing or absent matrix spike and the duplicate QC samples can be prevented. It is paramount that you hold the laboratory responsible to produce results that are representative of your sample matrix and that are true.

The next article will focus on how your business will develop a quality plan for your laboratory service provider with a specific focus on the California Code Of Regulations, Title 16, Division 42. Bureau Of Cannabis Control requirements.

Orange Photonics Introduces Terpenes+ Module in Portable Analyzer

By Aaron G. Biros
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Last week at the National Cannabis Industry Association’s (NCIA) Cannabis Business Summit, Orange Photonics unveiled their newest product added to their suite of testing instruments for quality assurance in the field. The Terpenes+ Module for the LightLab Cannabis Analyzer, which semi-quantitatively measures terpenes, Cannabichromene (CBC) and degraded THC, adds three new chemical analyses to the six cannabinoids it already reports.

CBC, a cannabinoid typically seen in hemp and CBD-rich plants, has been linked to some potentially impactful medical applications, much like the findings regarding the benefits of CBD. The module that tests for it, along with terpenes and degraded THC, can be added to the LightLab without any changes to hardware or sample preparation.

Dylan Wilks, chief technology officer of Orange Photonics
Dylan Wilks, chief technology officer of Orange Photonics

According to Dylan Wilks, chief technology officer of Orange Photonics, this could be a particularly useful tool for distillate producers looking for extra quality controls. Cannabis distillates are some of the most prized cannabis products around, but the heat used to create them can also create undesirable compounds,” says Wilks. “Distillate producers can see potency drop more than 25% if their process isn’t optimized”. With this new Terpenes+ Module, a distillate producer could quantify degraded THC content and get an accurate reading for their QC/QA department.

We spoke with Stephanie McArdle, president of Orange Photonics, to learn more about their instruments designed for quality assurance for growers and extractors alike.

Stephanie McArdle, president of Orange Photonics
Stephanie McArdle, president of Orange Photonics

According to McArdle, this could help cultivators and processors understand and value their product when terpene-rich products are the end goal. “Rather than try to duplicate the laboratory analysis, which would require expensive equipment and difficult sample preparation, we took a different approach. We report all terpenes as a single total terpene number,” says McArdle. “The analyzer only looks for monoterpenes (some common monoterpenes are myrcene, limonene and alpha-pinene), and not sesquiterpenes (the other major group of cannabis terpenes, such as Beta- Caryophyllene and Humulene) so the analysis is semi-quantitative. What we do is measure the monoterpenes and make an assumption that the sesquiterpenes are similar to an average cannabis plant to calculate a total terpene content.” She says because roughly 80% of terpenes found in cannabis are monoterpenes, this should produce accurate results, though some exotic strains may not result in accurate terpene content using this method.

The LIghtLab analyzer on the workbench
The LIghtLab analyzer on the workbench

As growers look to make their product unique in a highly competitive market, many are looking at terpenes as a source of differentiation. There are a variety of areas where growers can target higher terpene production, McArdle says. “During production, a grower may want to select plants for growing based on terpene content, or adjust nutrient levels, lighting, etc. to maximize terpenes,” says McArdle. “During the curing process, adjusting the environmental conditions to maximize terpene content is highly desirable.” Terpenes are also beginning to get recognized for their potential medical and therapeutic values as well, notably as an essential piece in the Entourage Effect. “Ultimately, it comes down to economics – terpene rich products have a higher market value,” says McArdle. “If you’re the grower, you want to prove that your product is superior. If you’re the buyer, you want to ensure the product you buy is high quality before processing it into other products. In both cases, knowing the terpene content is critical to ensuring you’re maximizing profits.”

Orange Photonics’ LightLab operates very similarly to instruments you might find in a cannabis laboratory. Many cannabis testing labs use High Performance Liquid Chromatography (HPLC) to analyze hemp or cannabis samples. “The primary difference between LightLab and an HPLC is that we operate at lower pressures and rely on spectroscopy more heavily than a typical HPLC analysis does,” says McArdle. “Like an HPLC, LightLab pushes an extracted cannabis sample through a column. The column separates the cannabinoids in the sample by slowing down cannabinoids by different amounts based on their affinity to the column.” McArdle says this is what allows each cannabinoid to exit the column at a different time. “For example, CBD may exit the column first, then D9THC and so on,” says McArdle. “Once the column separates the cannabinoids, they are quantified using optical spectroscopy- basically we are using light to do the final quantification.”

Dr. Ed Askew
From The Lab

Quality Plans for Lab Services: Managing Risks as a Grower, Processor or Dispensary, Part 3

By Dr. Edward F. Askew
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Dr. Ed Askew

Editor’s Note: The views expressed in this article are the author’s opinions based on his experience working in the laboratory industry. This is an opinion piece in a series of articles designed to highlight the potential problems that clients may run into with labs. 

In the last two articles, I discussed the laboratory’s first line of defense (e.g. certification or accreditation) paperwork wall used if a grower, processor or dispensary (user/client) questioned a laboratory result and the conflicts of interest that exist in laboratory culture. Now I will discuss the second line of defense that a laboratory will present to the user in the paperwork wall: Quality Control (QC) results.

Do not be discouraged by the analytical jargon of the next few articles. I suggest that you go immediately to the conclusions to get the meat of this article and then read the rest of it to set you on the path to see the forest for the trees.

QC in a laboratory consists of a series of samples run by the laboratory to determine the accuracy and precision of a specific batch of samples. So, to start off, let’s look at the definitions of accuracy and precision.QC Charts can provide a detailed overview of laboratory performance in a well-run laboratory.

According to the Standard Methods for the Examination of Water and Wastewater:

Accuracy: estimate of how close a measured value is to the true value; includes expressions for bias and precision.

Precision: a measure of the degree of agreement among replicate analyses of a sample.

A reputable laboratory will measure the Accuracy and Precision of QC samples in a batch of user samples and record these values in both the analytical test report issued to the user and in control charts kept by the laboratory. These control charts can be reviewed by the user if they are requested by the user. These control charts record:

Accuracy (means) chart: The accuracy chart for QC samples (e.g., LRB, CCV, LFBs, LFMs, and surrogates) is constructed from the average and standard deviation of a specified number of measurements of the analyte of interest.

Precision (range) chart: The precision chart also is constructed from the average and standard deviation of a specified number of measurements (e.g., %RSD or RPD) for replicate of duplicate analyses of the analyte of interest.

Now, let’s look at what should be run in a sample batch for cannabis analyses. The typical cannabis sample would have analyses for cannabinoids, terpenes, microbiological, organic compounds, pesticides and heavy metals.

Each compound listed above would require a specific validated analytical method for the type of matrix being analyzed. Examples of specific matrixes are:

  • Cannabis buds, leaves, oil
  • Edibles, such as Chocolates, Baked Goods, Gummies, Candies and Lozenges, etc.
  • Vaping liquids
  • Tinctures
  • Topicals, such as lotions, creams, etc.

Running QC analyses does not guarantee that the user’s specific sample in the batch was analyzed correctly.

Also, both ISO 17025-2005 and ISO 17025-2017 require the use of a validated method.

ISO 17025-2005: When it is necessary to use methods not covered by standard methods, these shall be subject to agreement with the customer and shall include a clear specification of the customer’s requirements and the purpose of the test and/or calibration. The method developed shall have been validated appropriately before use.

ISO 17025-2017: The laboratory shall validate non-standard methods, laboratory-developed methods and standard methods used outside their intended scope or otherwise modified. The validation shall be as extensive as is necessary to meet the needs of the given application or field of application.

Validation procedures can be found in a diverse number of analytical chemistry associations (such as AOACand ASTM) but the State of California has directed users and laboratories to the FDA manual “Guidelines for the Validation of Chemical Methods for the FDA FVM Program, 2nd Edition, 2015”

The laboratory must have on file for user review the following minimum results in an analytical statistical report validating their method:

  • accuracy,
  • limit of quantitation,
  • ruggedness,
  • precision,The user must look beyond the QC data provided in their analytical report or laboratory control charts.
  • linearity (or other calibration model),
  • confirmation of identity
  • selectivity,
  • range,
  • spike recovery.
  • limit of detection,
  • measurement uncertainty,

The interpretation of an analytical statistical report will be discussed in detail in the next article. Once the validated method has been selected for the specific matrix, then a sample batch is prepared for analysis.

Sample Batch: A sample batch is defined as a minimum of one (1) to a maximum of twenty (20) analytical samples run during a normal analyst’s daily shift. A LRB, LFB, LFM, LFMD, and CCV will be run with each sample batch. Failure of any QC sample in sample batch will require a corrective action and may require the sample batch to be reanalyzed. The definitions of the specific QC samples are described later.

The typical sample batch would be set as:

  • Instrument Start Up
  • Calibration zero
  • Calibration Standards, Quadratic
  • LRB
  • LFB
  • Sample used for LFM/LFMD
  • LFM
  • LFMD
  • Samples (First half of batch)
  • CCV
  • Samples (Second half of batch)
  • CCV

The QC samples are defined as:

Calibration Blank: A volume of reagent water acidified with the same acid matrix as in the calibration standards. The calibration blank is a zero standard and is used to calibrate the ammonia analyzer

Continuing Calibration Verification (CCV): A calibration standard, which is analyzed periodically to verify the accuracy of the existing calibration for those analytes.

Calibration Standard: A solution prepared from the dilution of stock standard solutions. These solutions are used to calibrate the instrument response with respect to analyte concentration

Laboratory Fortified Blank (LFB): An aliquot of reagent water or other blank matrix to which known quantities of the method analytes and all the preservation compounds are added. The LFB is processed and analyzed exactly like a sample, and its purpose is to determine whether the methodology is in control, and whether the laboratory is capable of making accurate and precise measurements.

Laboratory Fortified Sample Matrix/Duplicate (LFM/LFMD) also called Matrix Spike/Matrix Spike Duplicate (MS/MSD): An aliquot of an environmental sample to which known quantities of ammonia is added in the laboratory. The LFM is analyzed exactly like a sample, and its purpose is to determine whether the sample matrix contributes bias to the analytical results. The background concentrations of the analytes in the sample matrix must be determined in a separate aliquot and the measured values in the LFM corrected for background concentrations (Section 9.1.3).Laboratories must validate their methods.

Laboratory Reagent Blank (LRB): A volume of reagent water or other blank matrix that is processed exactly as a sample including exposure to all glassware, equipment, solvents and reagents, sample preservatives, surrogates and internal standards that are used in the extraction and analysis batches. The LRB is used to determine if the method analytes or other interferences are present in the laboratory environment, the reagents, or the apparatus.

Once a sample batch is completed, then some of the QC results are provided in the user’s analytical report and all of the QC results should be recorded in the control charts identified in the accuracy and precision section above.

But having created a batch and performing QC sample analyses, the validity of the user’s analytical results is still not guaranteed. Key conclusion points to consider are:

  1. Laboratories must validate their methods.
  2. Running QC analyses does not guarantee that the user’s specific sample in the batch was analyzed correctly.
  3. QC Charts can provide a detailed overview of laboratory performance in a well-run laboratory.

The user must look beyond the QC data provided in their analytical report or laboratory control charts. Areas to look at will be covered in the next few articles in this series.

California Manufacturing Regulations: What You Need To Know

By Aaron G. Biros
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In late November, California released their proposed emergency regulations for the cannabis industry, ahead of the full 2018 medical and adult use legalization for the state. We highlighted some of the key takeaways from the California Bureau of Cannabis Control’s regulations for the entire industry earlier. Now, we are going to take a look at the California Department of Public Health (CDPH) cannabis manufacturing regulations.

According to the summary published by the CDPH, business can have an A-type license (for products sold on the adult use market) and an M-type license (products sold on the medical market). The four license types in extraction are as follows:

  • Type 7: Extraction using volatile solvents (butane, hexane, pentane)
  • Type 6: Extraction using a non-volatile solvent or mechanical method
    (food-grade butter, oil, water, ethanol, or carbon dioxide)
  • Type N: Infusions (using pre-extracted oils to create edibles, beverages,
  • capsules, vape cartridges, tinctures or topicals)
  • Type P: Packaging and labeling only

As we discussed in out initial breakdown of the overall rules, California’s dual licensing system means applicants must get local approval before getting a state license to operate.

The rules dictate a close-loop system certified by a California-licensed engineer when using carbon dioxide or a volatile solvent in extraction. They require 99% purity for hydrocarbon solvents. Local fire code officials must certify all extraction facilities.

In the realm of edibles, much like the rule that Colorado recently implemented, infused products cannot be shaped like a human, animal, insect, or fruit. No more than 10mg of THC per serving and 100mg of THC per package is allowed in infused products, with the exception of tinctures, capsules or topicals that are limited to 1,000 mg of THC for the adult use market and 2,000 mg in the medical market. This is a rule very similar to what we have seen Washington, Oregon and Colorado implement.

On a somewhat interesting note, no cannabis infused products can contain nicotine, caffeine or alcohol. California already has brewers and winemakers using cannabis in beer and wine, so it will be interesting to see how this rule might change, if at all.

CA Universal Symbol (JPG)

The rules for packaging and labeling are indicative of a major push for product safety, disclosure and differentiating cannabis products from other foods. Packaging must be opaque, cannot resemble other foods packaged, not attractive to children, tamper-evident, re-sealable if it has multiple servings and child-resistant. The label has to include nutrition facts, a full ingredient list and the universal symbol, demonstrating that it contains cannabis in it. “Statute requires that labels not be attractive to individuals under age 21 and include mandated warning statements and the amount of THC content,” reads the summary. Also, manufacturers cannot call their product a candy.

Foods that require refrigeration and any potentially hazardous food, like meat and seafood, cannot be used in cannabis product manufacturing. They do allow juice and dried meat and perishable ingredients like milk and eggs as long as the final product is up to standards. This will seemingly allow for baked goods to be sold, as long as they are packaged prior to distribution.

Perhaps the most interesting of the proposed rules are requiring written standard operating procedures (SOPs) and following good manufacturing practices (GMPs). Per the new rules, the state will require manufacturers to have written SOPs for waste disposal, inventory and quality control, transportation and security.

Donavan Bennett, co-founder and CEO of the Cannabis Quality Group

According to Donavan Bennett, co-founder and chief executive officer of the Cannabis Quality Group, California is taking a page from the manufacturing and life science industry by requiring SOPs. “The purpose of an SOP is straightforward: to ensure that essential job tasks are performed correctly, consistently, and in conformance with internally approved procedures,” says Bennett. “Without having robust SOPs, how can department managers ensure their employees are trained effectively? Or, how will these department managers know their harvest is consistently being grown? No matter the employee or location.” California requiring written SOPs can potentially help a large number of cannabis businesses improve their operations. “SOPs set the tempo and standard for your organization,” says Bennett. “Without effective training and continuous improvement of SOPs, operators are losing efficiency and their likelihood of having a recall is greater.”

Bennett also says GMPs, now required by the state, can help companies keep track of their sanitation and cleanliness overall. “GMPs address a wide range of production activities, including raw material, sanitation and cleanliness of the premises, and facility design,” says Bennett. “Auditing internal and supplier GMPs should be conducted to ensure any deficiencies are identified and addressed. The company is responsible for the whole process and products, even for the used and unused products which are produced by others.” Bennett recommends auditing your suppliers at least twice annually, checking their GMPs and quality of raw materials, such as cannabis flower or trim prior to extraction.

“These regulations are only the beginning,” says Bennett. “As the consumer becomes more educated on quality cannabis and as more states come online who derives a significant amount of their revenue from the manufacturing and/or life science industries (e.g. New Jersey), regulations like these will become the norm.” Bennett’s Cannabis Quality Group is a provider of cloud quality management software for the cannabis industry.

“Think about it this way: Anything you eat today or any medicine you should take today, is following set and stringent SOPs and GMPs to ensure you are safe and consuming the highest quality product. Why should the cannabis industry be any different?”