This is the sixth and final in the series of articles designed to introduce an integrated pest management framework for cannabis cultivation facilities. To see Part One, an overview of the plan and pest identification, click here. For Part Two, on pest monitoring and record keeping, click here. For Part Three, on preventative measures, click here. For Part Four, control methods, click here. For Part Five, pest control action thresholds, click here.
This is Part 6: Emergency Response
When all prevention efforts have failed and your escalation procedures must be implemented, your emergency response document takes the stage.
Figure 1: We never want to see these at our door
It sounds obvious, but your emergency response document is your team’s guide to structure your response to an emergency. This begins with the simple definition of what is an emergency for your business. Emergencies can be to your personnel (personal injury) or your infrastructure (broken pipes/floods, power failure), and finally, a pest or pathogen outbreak that threatens the entire facility (insects/fungus, molds). Be sure to get the advice of your local service providers on the important things to put in to your response plan. This article is far from an exhaustive list, but it can get you started quickly with the basics for example purposes.
Personal Injury
Personal injuries are the events where you would call your local fire or police resources after stabilizing trauma events. Examples are chemical exposure, cuts, lacerations or broken bones from falls or crush events, burns, electric shock or earthquake or weather events. Injury response is to assess, call for medical assistance if appropriate, provide first aid and stabilize the injured, move to safety if possible, treat the injury and after the event is over and still fresh in everyone’s mind, consider what can be done to avoid the repeat of this or similar events in the future. Work those changes into your standard operating procedures.
Emergency Response to Facility Events
Figure 2: Cultivation IPM Prevention with Beneficial Insects
Whether the event is broken pipes or flooding, power failure or interruption, fire, HVAC failure or weather event, emergencies come in all sizes possible. It is likely that you built up a plan for emergency response as part of your city permitting process. Be sure to use those experts to refine your plan to include your operations.
Broken pipes start with the basics of turning off the source feeds and fixing the plumbing. If the water is actually rich fertilizer nutrients, cleaning and disinfectant is necessary as part of the drying and mop up process.
Environmental damage from fire, HVAC or weather event, lead to immediate treatment to try and save the current crops. This would include manual watering/misting, portable heater/cooler/CO2 burners. Verifying that backup power supplies turned on as planned. Are emergency fixes sufficient to power or run the systems necessary for plant life until power is returned?
Cultivation Events
Figure 3: Emergency Response Team Investigating Treatments
This entire paper has been about pest management, so emergency is expected to mean a pest or pathogen outbreak. We defined the escalated response actions up to the point of direct action and chemical interventions in chapters four and five. Your emergency response plan takes those actions to a site wide effort. Identify the pest and location/s that are causing the crisis, isolate the infested plants, remove the infected materials, clean, disinfect, and purify the contacted surfaces. Follow your plan and contact your emergency leaders.
Emergency Response Team
Your emergency response document identifies each of your team leaders and executives that are to be contacted in the event of an emergency. These leaders should be identified in the document with contact details and methods/on-call schedules for days and times of responsibility (after normal hours and holidays included). Someone is always on-call. The personal injury, facility and cultivation lead responsible should be identified and aware that they are the assigned resource and to treat emergencies as a priority.
Figure 4: IPM Preparation – Put It All Together for Success!
In Conclusion
We have covered an example integrated pest management philosophy from prevention through observation to limiting expansion to treatment and review. This continuous monitoring and learning process is a living document of standard operating procedures for any facility.
The attention of your team, their scouting observations, and attention to detail give you an opportunity to address and restrict any pest outbreak before it destroys your crop. Teach your operators well and reward them for their attention to your plan.
Clean and sterilize your facilities regularly. Preventing the emergence of pests will pay for the investment in a multitude of ways in both savings and profits. Plan your response thresholds and use traps to monitor your escalating protections. Target your treatments and remediations to match the threats to your harvests. As a last resort, apply approved chemical treatments judiciously to minimize the impact on non-target organisms.
Evaluate the effectiveness of your plan on an annual basis. Put your improvements to work for you to minimize your pest footprint and to increase your profits in every harvest.
This is the fourth in a series of articles designed to introduce an integrated pest management framework for cannabis cultivation facilities. To see Part One, an overview of the plan and pest identification, click here. For Part Two, on pest monitoring and record keeping, click here. For Part Three, on preventative measures, click here. Part Five comes out next week on how to build a framework for control actions and how to monitor them. More to come!
This is Part 4: Direct Control Options
Even when the best methods are implemented and precautions are taken to protect your infrastructure, determined pests can penetrate your perimeter. Before you see crawling, hopping or flying insects, or sickly-looking plants, be sure to implement your physical protection (positive pressure airflow sealed facilities) and personal hygiene methods (shoe baths, sticky mats, & air shower entrances) to protect your crops. Equip your employees with personal protection equipment (PPE) proper gloves, masks and clothing as discussed in our last chapter, preventative measures.
Figure 1: Fungus Gnats Unleashed In A Grow Room
When things do break-out beyond your acceptable thresholds, Direct Control Options include non-chemical microbial biofungicides, microbial bioinsecticides and direct chemical control options. Lots of big scary words there, all of which are toxic even under safe application methods and when used at recommended concentrations levels. This means training in their use and protective clothing is required. Careful application of these control options is necessary so you exterminate your pests and not your people! This seems obvious, but do not just “wing it.”
These chemical elements can be applied in diluted concentration levels, manual wipe-down application, concentrated flush frequencies, or root drench applications, foliar spray mist applications, HVAC aerial diffusions and aerial knock-down sprays. You may even choose to remove badly infected plants and destroy them completely.
Use experts when you are planning for these tools. All of these methods require handling and safety precautions. Proper breathing filters, eye & skin protection, as well as disposable gowns/hazmat suits should be used when applications are performed and until the applications have dissipated to safe levels. Be careful not to co-mingle removed plant materials. Gloves become transport and infection spreaders after use.
Please also be sure to review your harvest testing requirements and what treatments are safe for your consumers and within legal limits. No one wants to have their harvest rejected due to pesticide contamination.
Figure 2: Municipal Water Treatment, RAIR Cannabis, Michigan
Clean-up after application may be required depending on the bioinsecticide or chemical that is used. Again, always ensure the safety of your employees and take precautions.
Start the application of your control options with your site map, room assignments and scout monitoring teams. Where does air flow into and within the facility? When your scouting team count logs go beyond your acceptable thresholds, here are some options for you.
Let’s begin with cleaning your irrigation and nutrient water sources. For a walk-through tutorial for incoming water treatment, humidity recovery and nutrient water recycling, please review the video tour of Water Treatment at RAIR Cannabis to see how an expert has done it.
From the IPM Planning Guide standpoint, peroxide and acid sterilizers can be used to clear irrigation water, for surface wipe-downs or as direct plant applications. We will cover those first. Caustic sterilizers require PPE for cleaning. Forgive my image here, we were just using water.
Plant interacting interfaces, i.e. surfaces, benches, walls, floors, trays, utensils, clippers, etc. should be sterilized with every use. Methods can include direct wipe-down or scrub, concentrated or diluted sprays or room vaporizers. A good example of hydrogen peroxide (H2O2) liquid would be a food grade sanitizer with 3-35% H2O2 content. Use acceptable diluted versions of these cleaners as appropriate.
Figure 3: Cleaning & Scrubbing, Where’s the PPE?
A commercial example would be Zerotol 2.0 with 27% H2O2 & their proprietary acid mix. Alternatively, you can use direct hydrogen peroxide generators from commercial sources to generate your H2O2 at various concentrations. More detailed examples are included in the complete Integrated Pest Management Guide (link at the end of this article). Establish your procedures for sterilizing your rooms and tools before you introduce plants, and describe what is to be done after every harvest and room turn. Track the cleaning materials used for your operational records. You will find this useful to track operational cost over time.
Sanitizing Acids for Surfaces & Irrigation Sources
Similar to hydrogen peroxide, hypochlorous acid (HOCl) comes in many commercial forms and can also be generated onsite using purchased generators. Commercial mix examples are UC Roots, Watermax and Athena Cleanse. They come in 0.028% to 15% concentrations. Self-generators range in output from highly precise 0.01% to 1% concentrations with more examples in the guide.
Treatment Tools
OK, so enough on cleaning preparation. Here are some tools that can be used to fight back against a pest intrusion:
Non-Chemical Microbial Biofungicide for Pathogens in Soil or Fertigation Water
Microbial fungicides are available to clear nutrient irrigation systems by minimizing pathogens and improving plant resistance to infections. Some fungicide versions target root pathogens by attacking the diseases directly. Others control or suppress common water carried challenges like pythium, rhizoctonia, phytophthora, fusarium and others. Brand names include Botanicare, Bonide, BioWorks, Actinovate, Mycostop and many more. Details covered in the guide.
Non-Chemical Microbial Bioinsecticides for Larval Stages
These biological tools attack the organisms or insects at a physical or mechanical way by breaking down the pest’s nervous system, biochemistry, or structural integrity (exoskeletons, etc.). These are engineered or living organisms (bugs to attack bugs) that are developed as targeted attacks for specific pests. Brand names are BioCeres, Botanigard, Venerate, Bio Solutions and others.
Minimal Risk Chemical Pesticides for Airborne Critters
Figure 3: Example Fungus Gnat Infestation – Royal Queen Seeds blog
Regularly approved for used in most locales, essential oils, natural acids (like citric acid) and insecticidal soap are commonly available in every hydroponic store. These work very well as safe spray “knock-down” insecticides for crawling or flying pests. Commercial examples use a proprietary mix of various oils, citric acids or isopropyl alcohol to do their task (examples in guide). Insecticidal soaps and fungicides for surface cleaning perform a similar purpose and typically use potassium salts or fatty acid mixtures.
Biochemical Pesticides
These tools are used to inhibit insect or fungal growth to acceptable levels. The multifaceted and commonly used neem oil comes in many commercial versions and is a naturally occurring pesticide extracted from the leaves and seeds of the neem tree. Example brand names are Bonide, Monterey, Triact and others. They range in concentrations from 0.9% to 70% concentrations. These oils suffocate living organisms or eliminate moisture to kill insects, spores or fungus at their initiation and throughout their lifespan.
Another option here are Azadirachtins. These act as insect growth regulators and disrupt the bugs natural evolution. Brand names are AzaGuard, AzaMax and others in the guide.
In summary, this week
We summarized some of the many pest control options available for water treatment, soil borne, intermediate or flying pests. We also covered various concentrations for these pesticide and sterilizer options. If you are not familiar with dilution ratios, %, PPM terms and how to apply the correct level of pesticide, you may find our plant science test kitchen blog on this topic of use here.
Chemical access and use should be restricted to employees familiar with their authorized application. PPE is very important to protect any employee that will come in contact with materials, liquids or vapors for chemical resources (gloves, boots, respirators, Tyvek (or equivalent protective wear) suits and eye protection or goggles.
For more detail on each of these treatments, you can see examples for your integrated pest management procedures in our complete white paper for Integrated Pest Management Recommendations, download the document here.
In our next chapter, Pest Population Control Actions, we will review control thresholds and example plans for a range of problems from biofilm build up to white flies and more. Our final chapter after that will suggest an emergency response framework and how to address pest outbreaks. See you next week.
On the afternoon of October 6, President Biden issued a statement that many would call an October Surprise. Biden announced a three-part plan addressing cannabis reform, taking the first steps since he has taken office to address his campaign promise of tackling cannabis prohibition.
In his speech, Biden laid out the three steps he will take: First, he is pardoning all prior federal offenses for simple cannabis possession. Second, he is calling on all governors to do the same for state-level offenses. Thirdly, he announced that he is initiating a federal review of the current Schedule 1 status of cannabis.
Too many lives have been upended because of our failed approach to marijuana. Hear from @POTUS on the three steps he is taking to right these wrongs. pic.twitter.com/IqOxHxjgue
As I often said during my campaign for President, no one should be in jail just for using or possessing marijuana. Sending people to prison for possessing marijuana has upended too many lives and incarcerated people for conduct that many states no longer prohibit. Criminal records for marijuana possession have also imposed needless barriers to employment, housing, and educational opportunities. And while white and Black and brown people use marijuana at similar rates, Black and brown people have been arrested, prosecuted, and convicted at disproportionate rates.
Today, I am announcing three steps that I am taking to end this failed approach.
First, I am announcing a pardon of all prior Federal offenses of simple possession of marijuana. I have directed the Attorney General to develop an administrative process for the issuance of certificates of pardon to eligible individuals. There are thousands of people who have prior Federal convictions for marijuana possession, who may be denied employment, housing, or educational opportunities as a result. My action will help relieve the collateral consequences arising from these convictions.
Second, I am urging all Governors to do the same with regard to state offenses. Just as no one should be in a Federal prison solely due to the possession of marijuana, no one should be in a local jail or state prison for that reason, either.
Third, I am asking the Secretary of Health and Human Services and the Attorney General to initiate the administrative process to review expeditiously how marijuana is scheduled under federal law. Federal law currently classifies marijuana in Schedule I of the Controlled Substances Act, the classification meant for the most dangerous substances. This is the same schedule as for heroin and LSD, and even higher than the classification of fentanyl and methamphetamine – the drugs that are driving our overdose epidemic.
Finally, even as federal and state regulation of marijuana changes, important limitations on trafficking, marketing, and under-age sales should stay in place.
Too many lives have been upended because of our failed approach to marijuana. It’s time that we right these wrongs. – President Joe Biden
Even for the soaring cannabis industry, recruitment and retention of a qualified workforce remains a significant challenge in 2022. Although a tight labor market was not a new situation for many industries, the COVID-19 pandemic made it much worse and widespread, and the pain has yet to subside. In 2021, 47 million workers voluntarily left their jobs and nearly half of small businesses are experiencing worker shortages.
About 43% of workers who quit their jobs cited inadequate benefits as a factor in their decision. Among workers who cited benefits as a top concern, more than three-quarters said retirement plans are a “must-have” benefit. Most small businesses in the U.S. (74%) of 50 employees or fewer, however, do not check that box on a potential hire’s requirements list.
Offering a 401(k) plan, therefore, can help any company attract and retain workers. Even companies in emerging fields like cannabis can add 401(k) retirement savings plans to the roster of benefits for its employees.
In addition, there are tax benefits for the company should it offer a 401(k) plan and also match employee contributions. Employer contributions are deductible on the employer’s federal income tax return, so long as those contributions stay below the limitations described in section 404 of the Internal Revenue Service’s Internal Revenue Code.
Given the complexity of the cannabis industry and its hazy legal status in the U.S., however, it can be more challenging for cannabis companies to find benefits providers willing to create a program. Finding the right partners to navigate the process will help cannabis companies provide this significant employee benefit package.
Cannabis organizations have run into similar roadblocks finding banks and payroll providers willing to partner with them, and some large financial firms that offer retirement plans often decline to work with cannabis companies as well. But a growing number of boutique firms offer 401(k) programs and other benefits for this industry — it just requires the right partners to find the right plan.
Four tips for creating a 401(k) for cannabis workers
These four tips can help cannabis companies offer a 401(k):
Plan Structure and Objectives: Outline the goals of the 401(k) plan and how it will be set up, including how employees will be rewarded for participation. Consider developing a formal investment policy statement that includes monitoring the plan.
Matching Contributions and Auto-enrollment: Offering to match employee contributions tends to increase participation in retirement plans and increase employee satisfaction. There are a wide variety of paths the company could follow, but a good example would have the company matching 50% of salary up to 6%. Regarding automatic enrollment of employees into the plan, such a policy has shown to increase both participation and engagement.
401(k) 101: The company may need to educate its employees on the basics of a 401(k) plan if one was not offered previously. Employees may be unfamiliar with how these plans work and how to optimize their investment choices. Cannabis companies need to offer clear information on the benefits of the program, including information on managing their portfolio. This approach will make workers feel more comfortable with their investments and encourage engagement.
Partner with 401(k) Experts: Emerging industries like cannabis can be complex. Cannabis companies that want to implement a 401(k) should partner with consultants who understand the intricacies of the sector and know what retirement benefits companies cater to the industry.
Having a well-built grow room with adequate lighting, the ability to properly control the environment, proper nutrient feedings, a good pest management plan, well trained employees and an experienced cultivation manager are very important to the overall output of cannabis plants. However, even if you have all those measures in place, there’s no guarantee of success. One factor that is often overlooked is how many harvests you can get per year, as clearly the more harvests you can get in a given time period, the more likely your chances of success are in this competitive industry. This is why having a good cultivation plan in place, with proper foresight and planning, is so essential to success.
Increasing yield or production output in a cannabis cultivation facility can often be as simple as having the right cultivation plan in place to ensure that you are harvesting the maximum number of times per year. All it requires is a well thought out plan, and best of all, that does not cost any money if you have someone with enough cultivation experience assisting you and will earn back more than the cost of paying a consultant to get such a plan in place.
In this article I will explain why changing nutrients, grow media or even a cultivation manager may not necessarily increase yield, quality or your chance of success. What you should be focusing on is your cultivation plan and the scheduling of your cultivation cycles.
Why changing nutrient companies may not necessarily increase your yield
Nutrient dosers are used to inject fertilizer directly into irrigation lines
For the most part, nutrient companies use the same ingredients in their product lines and often buy them from the same source, but they combine them in different forms and ratios to create their “unique” product. You can go to a grow store, pick five different nutrient products, read the labels and compare the different nutrients in each one. You will find for the most part that they are very similar. Generally speaking, you could pick any one of those five nutrient companies and have great results. Mixing nutrients into a nutrient tank needs to be done precisely and if your employees are not doing it properly this can lead to plant health issues. In larger cultivation facilities, often nutrient dosers are used to inject fertilizer into the irrigation lines without having to mix nutrients. However, if the dosers are not set to the proper ratios, this can also lead to plant health issues.
There are a few companies that I really like that have a different approach to plant nutrition, which saves time and can prevent human error associated with mixing and applying liquid nutrients. Soilscape solutions, Organics Alive and Beanstock Agriculture all have nutrient lines that are intended to be used with soil or soilless media that can be amended into the soil which provide a slow steady release of nutrients that the plants can uptake as needed. This avoids the risk of human error in repeatedly applying liquid nutrients to the plants.
Why changing grow medium and nutrients will not necessarily improve your yield but may increase yourquality
Whether it is rock wool, coco fiber, a soilless mix or living soil, everything has a limit. Giving your plants the proper amount of water and the frequency at which you water, along with having sufficient room for the roots to grow are key factors to ensuring plant health. If your plants aren’t getting watered properly, no matter what media you are growing in, you will be having problems. Changing things like grow media won’t result in instant success, as there will always be a learning curve when making changes to your cultivation. If you cannot adapt quickly enough, you can quickly create major problems.
Changing things like grow media won’t result in instant success, as there will always be a learning curve when making changes to your cultivation.
You would be better off to master the grow media you are currently working; you will have more chance of success making slight alterations to your current media than you will if you switch your grow media altogether. There are so many different nutrient lines, soil companies, coco coir companies and the truth is any of them can lead to success.
Changing grow media and nutrients do play a large role in quality though. With cannabis being legalized in many states, the overall quality of cultivation inputs have increased, especially nutrients. However, in general, with some exceptions, the quality of cannabis has not necessarily increased along with the increase in quality of nutrients. One exception: I would argue that switching from salt nutrients and rock wool, to organic living soil will result in an improvement to the flavor, quality and terpenes of the cannabis.
A lot of people use rock wool with salts because it’s easier to scale up than if you are growing in soil, but some quality is also sacrificed. Soil is heavy and messy and most people throw their soil away which takes a lot of money and labor to do. Reusing your soil is one of the best ways to save time, money and increase quality. I had a friend that grew the same variety, same lights, same ventilation but grew hydroponically with salt-based nutrients and he would always say the cannabis I grew, organically, tasted better. The same was true when we grew the same variety outdoors. He used salt-based fertilizer, I used amended soil with water. There wasn’t really a comparison in flavor and the yield was not compromised either! This was his opinion not mine.
I think the vast majority of consumers have not seen the type of quality that someone in Northern California who has been smoking and growing for 20 plus years has seen. Quality is relative to what you have been able to acquire. Most people especially nowadays will never see the quality that used to be common when we didn’t treat the sacred herb like a commodity. When you do it for the love of the plant it shows. Remember, quality is relative to your experience and if salty weed is all you know, you are probably missing out.
Why changing your Cultivation manager may not necessarily increase your yield
Every cultivation facility should have an experienced cultivation manager who is knowledgeable in the areas of nutrient requirements, pest management, environmental requirements, managing employees and overall facilities operations. If a grow room cannot sustain the proper environmental set points, blaming the problems and issues that arise on the cultivation manager is not fair. It is a common problem in the cannabis industry – the owners of a company are not seeing the results that they want and think that by replacing the cultivation manager it will solve all their problems. In reality, often the problem results from upper management or owners of the company not providing the cultivation manager the tools necessary to perform their job at the highest level. Another common problem is when owners fire the cultivation manager and replace them with lower-level employees to manage the facility. The problem with this is those employees do not have enough experience nor the attention to detail to successfully run a cultivation facility. The result is that yield and quality suffer tremendously.
You should be harvesting every 60-70 days
If you are cultivating strains that finish flowering in 60 to 70 days you should be getting five harvests per year.
The reality is there is no one specific thing you can try or buy that will result in success. It is everything combined, the HVAC system, lights, genetics being grown, water quality, air quality, root zone temperature, ability to control environment, having a clean facility, disease free plants, knowledgeable cultivation manager etc. that are required to operate a successful cultivation.
But all of that is less important to yield than a good cultivation plan. Cultivation methods directly tie into the overall production of a facility. But, regardless of whether you’re growing in soil, hydroponics, using LED or HPS, have low or high plant counts, if you don’t have the ability to harvest a grow room, clean and replant within a very short amount of time (ideally one or two days) then you’re going to be losing out on profit.
If you’re cultivating strains that finish flowering in under 60 days you should be getting six harvests per year. If you are cultivating strains that finish flowering in 60 to 70 days you should be getting five harvests per year. To do this, you will need to have the appropriate amount of plants that are ready to be flowered to refill your grow room or greenhouse ready to flower. With a little bit of planning and foresight you will be able to do this, and you will be on your way to producing your highest yield potential.
If you are struggling to have enough plants that are ready to flower once you are done harvesting and cleaning your grow room, having trouble planning your cultivation schedule to maximize production, or struggling to maintain a mother and clone room to supply your own plants or planning for the appropriate amount of labor, contact Floresco Consulting and talk with one of our cultivation advisors to get you back on track. We can guide you to ensure you are harvesting, cleaning and replanting every 60 days. Contact us today to get your facility producing at its maximum potential.
Three years ago, Canada became one of the first countries in the world to legalize and regulate cannabis. We’ve covered various aspects of cannabis regulation since, but now with a few years of data readily available, it’s time to step back and assess: what can we learn from three years of cannabis recalls in the world’s largest legal market?
Labelling Errors are the Leading Cause of Canadian Cannabis Recalls
Our analysis of Health Canada’s data revealed a clear leader: most cannabis recalls since legalization in October 2018 have been due to labelling and packaging errors. In fact, over three quarters of total cannabis recalls were issued for this reason, covering more than 140,000 units of recalled product.
The most common source of labelling and packaging recalls in the cannabis industry (more than half) is inaccurate cannabinoid information. Peace Naturals Project’s recall of Spinach Blue Dream dried cannabis pre-rolls this year is a good example. Not only did the packaging incorrectly read that the product contained CBD, but the THC quantity listed was lower than the actual amount of THC in the product. The recall covered over 13,000 units from a single lot sold over 10 weeks.
In another example, a minor error made a huge impact. British Columbia-based We Grow BC Ltd. experienced this firsthand when it misplaced the decimal points in its cannabinoid content. The recalled products displayed the total THC and CBD values as 20.50 mg/g and 0.06 mg/g, respectively, when the products contained 205.0 mg/g and 0.6 mg/g.
Accurate potency details are not just crucial for compliance. For many customers, potency is a deciding factor when selecting a cannabis product, and this is especially important for medicinal users (including children), people who are sensitive to certain cannabinoids and consumers looking for non-psychoactive effects. In this case, at least six consumer complaints were submitted to Peace Naturals Project, the highest number for any cannabis recall in Canada.
Pathogens are the #2 Cause of Cannabis Recalls in Canada
Pathogens are the second most common cause of recalls in Canada, claiming 18% of total cannabis recall incidents. And while that doesn’t sound like much compared to the recalls caused by labelling errors, it affects the highest volume of product recalled with over 360,000 units affected.
Canadian Cannabis Recalls – Total number of affected units and noted causes
A primary cause of allergens and microbiological contamination of cannabis products is yeast, mold and bacteria found on cannabis flower (chemical contaminants like pesticides can also be a major concern). Companies like Atlas Growers, Natural MedCo and Agro-Greens Natural Products have all learned this lesson through costly recalls.
These allergenic contaminants pose an obvious health risk, often leading to reactions such as wheezing, sneezing and itchy eyes. For people using cannabis for medical conditions and may be more susceptible to illness, pathogens can cause more serious health complications. Moreover, this type of cannabis recall not only drives significant cost since microbiological contamination of flower could easily affect several product batches processed in the same facility and/or trigger downstream recalls, but also affect consumer confidence for established cannabis brands.
Preventive control plan requirements for cannabis manufacturers mandate that holders of a license for processing that produce edible cannabis or cannabis extracts in Canada must identify and analyze the biological, chemical and physical hazards that present a risk of contamination to the cannabis or anything that would be used as an ingredient in the production of the edible cannabis or cannabis extract. Biological hazards can come from a number of sources, including:
Incoming ingredients, including raw materials
Cross-contamination in the processing or storage environment
Employees
Cannabis extract, edible cannabis and ingredient contact surfaces
Air
Water
Insects and rodents
To mitigate risks, addressing root causes with preventative measures and controls is essential. For instance, high humidity levels and honeydew secreted by insects are common causes of mold on cannabis flowers. Measures such as leaving a reasonable distance between plants, using climate-controlled areas to dry flowers, applying antifungal agents and conducting regular tests are necessary to combat such incidents.
Preventative measures and controls can save a business from extremely costly recalls.
Of course, placing all the necessary controls into action is not as simple as it may sound. Multiple facilities and a wide range of products in production mean more complexity for cannabis producers and processors. Any gaps in processing flower, extracts or edibles can result in an uncontrolled safety hazard that may lead to a costly cannabis recall.
These challenges are not just limited to cannabis growers. The food industry has been effectively mitigating the risk of biological hazards for decades with the help of food ERP solutions.
Avoid Recalls Altogether with Advanced ERP Technology
An effective preventative control plan with regular quality checks, internal audits and standardized testing is important to minimize the threats evident from Canada’s recall data. If these measures ever fail, real-time traceability systems play a pivotal role in the event of a cannabis recall by enabling manufacturers to trace back incidents to the exact point of contamination and identify affected products with surgical precision.
Instead of starting from zero, savvy cannabis industry leaders turn to the proven solutions from the food industry and take advantage of data-driven, automated systems that deliver the reliability and safety that the growing industry needs. From automated label generation to integrated lab testing to quality checks to precision traceability and advanced reporting, production and quality control systems are keys to success for the years ahead.
Facility layout and design are important components of overall operations, both in terms of maximizing the effectiveness and efficiency of the process(es) executed in a facility, and in meeting the needs of personnel. Prior to the purchase of an existing building or investing in new construction, the activities and processes that will be conducted in a facility must be mapped out and evaluated to determine the appropriate infrastructure and flow of processes and materials. In cannabis markets where vertical integration is the required business model, multiple product and process flows must be incorporated into the design and construction. Materials of construction and critical utilities are essential considerations if there is the desire to meet Good Manufacturing Practice (GMP) compliance or to process in an ISO certified cleanroom. Regardless of what type of facility is needed or desired, applicable local, federal and international regulations and standards must be reviewed to ensure proper design, construction and operation, as well as to guarantee safety of employees.
Materials of Construction
The materials of construction for interior work surfaces, walls, floors and ceilings should be fabricated of non-porous, smooth and corrosive resistant surfaces that are easily cleanable to prevent harboring of microorganisms and damage from chemical residues. Flooring should also provide wear resistance, stain and chemical resistance for high traffic applications. ISO 22196:2011, Measurement Of Antibacterial Activity On Plastics And Other Non-Porous Surfaces22 provides a method for evaluating the antibacterial activity of antibacterial-treated plastics, and other non-porous, surfaces of products (including intermediate products). Interior and exterior (including the roof) materials of construction should meet the requirements of ASTM E108 -11, Standard Test Methods for Fire Tests of Roof Covering7, UL 790, Standard for Standard Test Methods for Fire Tests of Roof Coverings 8, the International Building Code (IBC) 9, the National Fire Protection Association (NFPA) 11, Occupational Safety and Health Administration (OSHA) and other applicable building and safety standards, particularly when the use, storage, filling, and handling of hazardous materials occurs in the facility.
Utilities
Critical and non-critical utilities need to be considered in the initial planning phase of a facility build out. Critical utilities are the utilities that when used have the potential to impact product quality. These utilities include water systems, heating, ventilation and air conditioning (HVAC), compressed air and pure steam. Non-critical utilities may not present a direct risk to product quality, but are necessary to support the successful, compliant and safe operations of a facility. These utilities include electrical infrastructure, lighting, fire detection and suppression systems, gas detection and sewage.
Water
Microbial monitoring methods can include frequent/consistent testing
Water quality, both chemical and microbial, is a fundamental and often overlooked critical parameter in the design phase of cannabis operations. Water is used to irrigate plants, for personnel handwashing, potentially as a component in compounding/formulation of finished goods and for cleaning activities. The United States Pharmacopeia (USP) Chapter 1231, Water for Pharmaceutical Purposes 2, provides extensive guidance on the design, operation, and monitoring of water systems. Water quality should be tested and monitored to ensure compliance to microbiological and chemical specifications based on the chosen water type, the intended use of the water, and the environment in which the water is used. Microbial monitoring methods are described in USP Chapter 61, Testing: Microbial Enumeration Tests3and Chapter 62, Testing: Tests for Specified Microorganisms 4, and chemical monitoring methods are described in USP Chapter 643, Total Organic Carbon 5, and Chapter 645, Water Conductivity6.Overall water usage must be considered during the facility design phase. In addition to utilizing water for irrigation, cleaning, product processing, and personal hygiene, water is used for heating and cooling of the HVAC system, fogging in pest control procedures and in wastewater treatment procedures A facility’s water system must be capable of managing the amount of water required for the entire operation. Water usage and drainage must meet environmental protection standards. State and local municipalities may have water usage limits, capture and reuse requirements and regulations regarding runoff and erosion control that must also be considered as part of the water system design.
Lighting
Lighting considerations for a cultivation facility are a balance between energy efficiency and what is optimal for plant growth. The preferred lighting choice has typically been High Intensity Discharge (HID) lighting, which includes metal halide (MH) and high-pressure sodium (HPS) bulbs. However, as of late, light-emitting diodes (LED) systems are gaining popularity due to increased energy saving possibilities and innovative technologies. Adequate lighting is critical for ensuring employees can effectively and safely perform their job functions. Many tasks performed on the production floor or in the laboratory require great attention to detail. Therefore, proper lighting is a significant consideration when designing a facility.
HVAC
Proper lighting is a significant consideration when designing a facility.
Environmental factors, such as temperature, relative humidity (RH), airflow and air quality play a significant role in maintaining and controlling cannabis operations. A facility’s HVAC system has a direct impact on cultivation and manufacturing environments, and HVAC performance may make or break the success of an operation. Sensible heat ratios (SHRs) may be impacted by lighting usage and RH levels may be impacted by the water usage/irrigation schedule in a cultivation facility. Dehumidification considerations as described in the National Cannabis Industry Association (NCIA) Committee Blog: An Introduction to HVACD for Indoor Plant Environments – Why We Should Include a “D” for Dehumidification 26 are critical to support plant growth and vitality, minimize microbial proliferation in the work environment and to sustain product shelf-life/stability. All of these factors must be evaluated when commissioning an HVAC system. HVAC systems with monitoring sensors (temperature, RH and pressure) should be considered. Proper placement of sensors allows for real-time monitoring and a proactive approach to addressing excursions that could negatively impact the work environment.
Compressed Air
Compressed air is another, often overlooked, critical component in cannabis operations. Compressed air may be used for a number of applications, including blowing off and drying work surfaces and bottles/containers prior to filling operations, and providing air for pneumatically controlled valves and cylinders. Common contaminants in compressed air are nonviable particles, water, oil, and viable microorganisms. Contaminants should be controlled with the use appropriate in-line filtration. Compressed air application that could impact final product quality and safety requires routine monitoring and testing. ISO 8573:2010, Compressed Air Specifications 21, separates air quality levels into classes to help differentiate air requirements based on facility type.
Electrical Infrastructure
Facilities should be designed to meet the electrical demands of equipment operation, lighting, and accurate functionality of HVAC systems. Processes and procedures should be designed according to the requirements outlined in the National Electrical Code (NEC) 12, Institute of Electrical and Electronics Engineers (IEEE) 13, National Electrical Safety Code (NESC) 14, International Building Code (IBC) 9, International Energy Conservation Code (IECC) 15 and any other relevant standards dictated by the Authority Having Jurisdiction (AHJ).
Fire Detection and Suppression
“Facilities should be designed so that they can be easily expanded or adjusted to meet changing production and market needs.”Proper fire detection and suppression systems should be installed and maintained per the guidelines of the National Fire Protection Association (NFPA) 11, International Building Code (IBC) 9, International Fire Code (IFC) 10, and any other relevant standards dictated by the Authority Having Jurisdiction (AHJ). Facilities should provide standard symbols to communicate fire safety, emergency and associated hazards information as defined in NFPA 170, Standard for Fire Safety and Emergency Symbols27.
Gas detection
Processes that utilize flammable gasses and solvents should have a continuous gas detection system as required per the IBC, Chapter 39, Section 3905 9. The gas detection should not be greater than 25 percent of the lower explosive limit/lower flammability limit (LEL/LFL) of the materials. Gas detection systems should be listed and labeled in accordance with UL 864, Standard for Control Units and Accessories for Fire Alarm Systems16 and/or UL 2017, Standard for General-Purpose Signaling Devices and Systems 17 and UL 2075, Standard for Gas and Vapor Detectors and Sensors18.
Product and Process Flow
Product and process flow considerations include flow of materials as well as personnel. The classic product and process flow of a facility is unidirectional where raw materials enter on one end and finished goods exit at the other. This design minimizes the risk of commingling unapproved and approved raw materials, components and finished goods. Facility space utilization is optimized by providing a more streamlined, efficient and effective process from batch production to final product release with minimal risk of errors. Additionally, efficient flow reduces safety risks to employees and an overall financial risk to the organization as a result of costly injuries. A continuous flow of raw materials and components ensures that supplies are available when needed and they are assessable with no obstructions that could present a potential safety hazard to employees. Proper training and education of personnel on general safety principles, defined work practices, equipment and controls can help reduce workplace accidents involving the moving, handling, and storing of materials.
Facilities Management
Facilities management includes the processes and procedures required for the overall maintenance and security of a cannabis operation. Facilities management considerations during the design phase include pest control, preventative maintenance of critical utilities, and security.
Damage from whiteflies, thrips and powdery mildew could be prevented with an appropriate PCP
A Pest Control Program (PCP) ensures that pest and vermin control is carried out to eliminate health risks from pests and vermin, and to maintain the standards of hygiene necessary for the operation. Shipping and receiving areas are common entryways for pests. The type of dock and dock lever used could be a welcome mat or a blockade for rodents, birds, insects, and other vermin. Standard Operating Procedures (SOPs) should define the procedure and responsibility for PCP planning, implementation and monitoring.
Routine preventative maintenance (PM) on critical utilities should be conducted to maintain optimal performance and prevent microbial and/or particulate ingress into the work environment. Scheduled PMs may include filter replacement, leak and velocity testing, cleaning and sanitization, adjustment of airflow, the inspection of the air intake, fans, bearings and belts and the calibration of monitoring sensors.
In most medical cannabis markets, an established Security Program is a requirement as part of the licensing process. ASTM International standards: D8205 Guide for Video Surveillance System 23, D8217 Guide for Access Control System[24], and D8218 Guide for Intrusion Detection System (IDS) 25 provide guidance on how to set up a suitable facility security system and program. Facilities should be equipped with security cameras. The number and location of the security cameras should be based on the size, design and layout of the facility. Additional cameras may be required for larger facilities to ensure all “blind spots” are addressed. The facility security system should be monitored by an alarm system with 24/7 tracking. Retention of surveillance data should be defined in an SOP per the AHJ. Motion detectors, if utilized, should be linked to the alarm system, automatic lighting, and automatic notification reporting. The roof area should be monitored by motion sensors to prevent cut-and-drop intrusion. Daily and annual checks should be conducted on the alarm system to ensure proper operation. Physical barriers such as fencing, locked gates, secure doors, window protection, automatic access systems should be used to prevent unauthorized access to the facility. Security barriers must comply with local security, fire safety and zoning regulations. High security locks should be installed on all doors and gates. Facility access should be controlled via Radio Frequency Identification (RFID) access cards, biometric entry systems, keys, locks or codes. All areas where cannabis raw material or cannabis-derived products are processed or stored should be controlled, locked and access restricted to authorized personnel. These areas should be properly designated “Restricted Area – Authorized Personnel Only”.
Future Expansion
The thought of expansion in the beginning stages of facility design is probably the last thing on the mind of the business owner(s) as they are trying to get the operation up and running, but it is likely the first thing on the mind of investors, if they happen to be involved in the business venture. Facilities should be designed so that they can be easily expanded or adjusted to meet changing production and market needs. Thought must be given to how critical systems and product and process flows may be impacted if future expansion is anticipated. The goal should be to minimize down time while maximizing space and production output. Therefore, proper up-front planning regarding future growth is imperative for the operation to be successful and maintain productivity while navigating through those changes.
References:
United States Environmental Protection Agency (EPA) Safe Drinking Water Act (SDWA).
United States Pharmacopeia (USP) Chapter <1231>, Water for Pharmaceutical Purposes.
United States Pharmacopeia (USP) Chapter <61>, Testing: Microbial Enumeration Tests.
United States Pharmacopeia (USP) Chapter <62>, Testing: Tests for Specified Microorganisms.
United States Pharmacopeia (USP) Chapter <643>, Total Organic Carbon.
United States Pharmacopeia (USP) Chapter <645>, Water Conductivity.
ASTM E108 -11, Standard Test Methods for Fire Tests of Roof Coverings.
UL 790, Standard for Standard Test Methods for Fire Tests of Roof Coverings.
International Building Code (IBC).
International Fire Code (IFC).
National Fire Protection Association (NFPA).
National Electrical Code (NEC).
Institute of Electrical and Electronics Engineers (IEEE).
National Electrical Safety Code (NESC).
International Energy Conservation Code (IECC).
UL 864, Standard for Control Units and Accessories for Fire Alarm Systems.
UL 2017, Standard for General-Purpose Signaling Devices and Systems.
UL 2075, Standard for Gas and Vapor Detectors and Sensors.
International Society for Pharmaceutical Engineers (ISPE) Good Practice Guide.
International Society for Pharmaceutical Engineers (ISPE) Guide Water and Steam Systems.
ISO 8573:2010, Compressed Air Specifications.
ISO 22196:2011, Measurement Of Antibacterial Activity On Plastics And Other Non-Porous Surfaces.
D8205 Guide for Video Surveillance System.
D8217 Guide for Access Control Syst
D8218 Guide for Intrusion Detection System (IDS).
National Cannabis Industry Association (NCIA): Committee Blog: An Introduction to HVACD for Indoor Plant Environments – Why We Should Include a “D” for Dehumidification.
NFPA 170, Standard for Fire Safety and Emergency Symbols.
Cross Contamination – noun – “inadvertent transfer of bacteria or other contaminants from one surface, substance, etc., to another especially because of unsanitary handling procedures. – (Mariam Webster, 2021). Cross contamination is not a new concept in the clinical and food lab industries; many facilities have significant design aspects as well as SOPs to deliver the least amount of contaminants into the lab setting. For cannabis labs, however, often the exponential growth leads to a circumstance where the lab simply isn’t large enough for the number of samples processed and number of analytical instruments and personnel needed to process them. Cross contamination for cannabis labs can mean delayed results, heightened occurrences of false positives, and ultimately lost customers – why would you pay for analysis of your clean product in a dirty facility? The following steps can save you the headaches associated with cross contamination:
Wash (and dry) your hands properly
Flash back to early pandemic times when the Tik Tok “Ghen Co Vy” hand washing song was the hotness – we had little to no idea that the disease would be fueled mostly by aerosol transmission, but the premise is the same, good hand hygiene is good to reduce cross contamination. Hands are often the source of bacteria, both resident (here for the long haul; attached to your hands) and transient (easy to remove; just passing through), as they come into contact with surfaces from the bathroom to the pipettor daily (Robinson et al, 2016). Glove use coupled with adequate hand washing are good practices to reduce cross contamination from personnel to a product sample. Additionally, the type of hand drying technique can reduce the microbial load on the bathroom floors and, subsequently tracked into the lab. A 2013 study demonstrated almost double the contamination from air blade technology versus using a paper towel to dry your hands (Margas et al, 2013).
Design Your Lab for Separation
Microbes are migratory. In fact, E. coli can travel at speeds up to 15 body lengths per second. Compared to the fastest Olympians running the 4X100m relay, with an average speed of 35 feet per second or 6 body lengths, this bacterium is a gold medal winner, but we don’t want that in the lab setting (Milo and Phillips, 2021). New lab design keeps this idea of bacterial travel in mind, but for those labs without a new build, steps can be made to prevent contamination:
Try to keep traffic flow moving in one direction. Retracing steps can lead to contamination of a previous work station
Use separate equipment (e.g. cabinets, pipettes) for each process/step
Separate pre- and post-pcr areas
Physical separation – use different rooms, add walls, partitions, etc.
Establish, Train and Adhere to SOPs
Design SOPs that include everything- from hygiene to test procedures and sanitation.
High turnover for personnel in labs causes myriad issues. It doesn’t take long for a lab that is buttoned up with cohesive workflows to become a willy-nilly hodgepodge of poor lab practices. A lack of codified Standard Operating Procedures (SOPs) can lead to a lab rife with contaminants and no clear way to troubleshoot the issue. Labs should design strict SOPs that include everything from hand hygiene to test procedures and sanitation. Written SOPs, according to the WHO, should be available at all work stations in their most recent version in order to reduce biased results from testing (WHO, 2009). These SOPs should be relayed to each new employee and training on updated SOPs should be conducted on an ongoing basis. According to Sutton, 2010, laboratory SOPs can be broken down into the following categories:
Quality requirements
Media
Cultures
Equipment
Training
Sample handling
Lab operations
Testing methodology
Data handling/reporting/archiving
Investigations
Establish Controls and Monitor Results
Scanning electron micrograph shows a colony of Salmonella typhimurium bacteria. Photo courtesy of CDC, Janice Haney Carr
It may be difficult for labs to keep tabs on positivity and fail rates, but these are important aspects of a QC regimen. For microbiological analysis, labs should use an internal positive control to validate that 1) the method is working properly and 2) positives are a result of target analytes found in the target matrix, not an internal lab contamination strain. Positive controls can be an organism of choice, such as Salmonella Tranoroa, and can be tagged with a marker, such as Green Fluorescent Protein in order to differentiate the control strain. These controls will allow a lab tech to discriminate between a naturally contaminated specimen vs. a positive as a result of cross-contamination.
Labs should, in addition to having good QC practices, keep track of fail rates and positivity rates. This can be done as total lab results by analysis, but also can be broken down into customers. For instance, a lab fail rate for pesticides averages 4% for dried flower samples. If, during a given period of review, this rate jumps past 6% or falls below 2%, their may be an issue with instrumentation, personnel or the product itself. Once contamination is ruled out, labs can then present evidence of spikes in fail rates to growers who can then remediate in their own facilities. These efforts in concert will inherently drive down fail rates, increase lab capacity and efficiency, and result in cost savings for all parties associated.
Continuous Improvement is the Key
Cannabis testing labs are, compared to their food and clinical counterparts, relatively new. The lack of consistent state and federal regulation coupled with unfathomable growth each year, means many labs have been in the “build the plane as you fly” mode. As the lab environment matures, simple QC, SOP and hygiene changes can make an incremental differences and drive improvements for labs as well as growers and manufacturers they support. Lab management can, and should, take steps to reduce cross contamination, increase efficiency and lower costs; The first step is always the hardest, but continuous improvement cannot begin until it has been taken.
References
Margas, E, Maguire, E, Berland, C. R, Welander, F, & Holah, J. T. (2013). Assessment of the environmental microbiological cross contamination following hand drying with paper hand towels or an air blade dryer. Journal of Applied Microbiology, 115(2), 572-582.
Milo, M., and Phillips, R. (2021). How fast do cells move? Cell biology by the numbers. Retrieved from http://book.bionumbers.org/how-fast-do-cells-move/
Robinson, Andrew L, Lee, Hyun Jung, Kwon, Junehee, Todd, Ewen, Perez Rodriguez, Fernando, & Ryu, Dojin. (2016). Adequate Hand Washing and Glove Use Are Necessary To Reduce Cross-Contamination from Hands with High Bacterial Loads. Journal of Food Protection, 79(2), 304–308. https://doi.org/10.4315/0362-028X.JFP-15-342
Sutton, Scott. (2010). The importance of a strong SOP system in the QC microbiology lab. Journal of GXP Compliance, 14(2), 44.
World Health Organization. (2009). Good Laboratory Practice Handbook. Retrieved from https://www.who.int/tdr/publications/documents/glp-handbook.pdf
No business is perfect, especially when humans are part of the equation. But, how do you tackle fixing quality issues as they arise? The goal of this article is to shed some light on the value of a CAPA program and why many states are making them mandatory for cannabis businesses.
Let’s consider the following situations:
Analytical lab results for a production batch test above the limit for a banned pesticide or microbial contamination
You open a case of tincture bottles and some are broken
A customer returns a vape pen because it is leaking or ‘just doesn’t work’
Do you…
Document the issue?
Perform some sort of an investigation, asking questions of the people involved?
Ask for a retest? Then, if the test comes back positive, move on?
Let’s go through each one of these and understand why the suboptimal answer could be costing your business money:
You don’t document the issue
I hear excuses for skipping on documentation all the time.
“It’s not a big deal”
“It was a one off”
“The glasses probably broke in transit”
“They are cheap and easily replaceable”
“It’s not worth the time”
Tracking and documenting supplier shipments can help you identify supply chain issues.
In the situation of a couple of broken bottles in a shipment, what if it was the seventh time in the last two months? If you haven’t been documenting and tracking the issue, you have no way of knowing if it was a single occurrence. Remember when you were surprised that your filling team did not have enough bottles? Those broken bottles add up. Without documenting the incident, you will never know if it was truly a one-time mistake or the sign of a deeper issue. The reality is, it could be sloppy handling on the production line, issues with the shipper or even a sign of poor quality coming from the supplier.
Have you ever compared the number of fills vs the number of bottles ordered? How much money have you already lost due to those broken bottles adding up? Do you have the ability to answer this question?
You perform an investigation
Let’s say a customer returns a leaky vape pen. You perform an investigation by asking the production workers what they think went wrong. They say that it’s very difficult to get the seal for the cartridge into place. Their supervisor tells them to try harder, refunds the customer and moves on. But, why is it difficult to get the seal into place? Is it a design flaw? Should a special tool be used to assemble the cartridge properly? Without getting to the root cause of why the seals are leading to leaking cartridges, you are doomed to have repeat issues. Numerous studies have found that less than one in twenty dissatisfied customers will complain, and that approximately one in ten will simply leave for another brand or provider. How much is this unresolved issue truly costing your business?
Asking for a retest and if it passes, releasing the product and moving on.
In Colorado, 15% of the final tested cannabis flower products continue to fail.
Suppose a major producer of cereal received test results for its most popular cereal that were positive for levels of heavy metals that research has shown to be linked to cancer or developmental issues in children. Now, suppose the company stated that it was an isolated incident and a retest showed that the product met acceptable limits. Further investigation showed no paperwork, save for a couple of emails and a phone call between the lab and the producer. Would that give you peace of mind? This is known as “testing into compliance” and was the subject of a landmark lawsuit in 1993 that Barr Laboratories lost.
For many the answer would be a hard NO. But this happens every day. In Colorado, 12.5% of cannabis batches failed final product testing in 2018 and 2019. That’s one in eight batches! What happened to those products? Good question.
Enter: CAPA (Corrective Action and Preventive Action) programs! For people with a background in quality and GMPs (Good Manufacturing Practices), CAPA is a household name. And, it’s quickly becoming a requirement that cannabis regulatory bodies are looking at. Colorado was the first state to explicitly require CAPA programs for all license holders effective January of this year and has provided a free resource for them. But, for the large majority of people, including those in the cannabis industry, it’s just another acronym.
What does a CAPA program do?
The benefits are numerous but two major ones are:
An effective tool for investigating the true root cause
First of all, a CAPA program provides the framework for a tool for investigation – as Murphy’s Law posits – things go wrong all of the time. Whether you have a manual, labor-intensive process or a highly automated operation, the equipment is programmed, maintained and monitored by humans. The logical sequence of problem solving within a CAPA program allows you to thoroughly investigate and determine the root cause of the issue. With a complete understanding of root cause, you are then able to eliminate it and prevent future occurrences – not just in the one area investigated, but in all similar situations throughout the company.
System for continuous improvement
Gathering info from a customer complaint like batch or product IDs can be crucial in a CAPA system
Anyone who is in the market for a new car lately can appreciate the technological advances. In the 1980s, it was air bags and ABS brakes (those of you that drive in snowy climates and remember having to pump your brakes can appreciate technological advancements). Bluetooth technology for hands-free communication and radio control is another example of continuous improvement in cars.
This is one of the biggest predictors and differentiators between profitable and successful companies with satisfied clients and one that is barely scraping by. The cost of poor quality adds up!
Key inputs in a CAPA system
If the output is an improved system and lower cost of quality, we need to make sure we’re considering the potential inputs.
Information that feeds into your CAPA system:
Customer complaints
Every complaint must be recorded. Gather as much information as possible, but at a minimum: the product type/SKU, the customer name and date of purchase. If possible, the batch or product ID.
This is not necessarily to identify products for a recall, but to prevent…
Laboratory test results
This should not be restricted to final product testing, but include any in-process inspections. Say you have a product repeatedly failing final testing, what if it’s actually been consistently failing or very close to failing at the very first in-process inspection? It’s also important to work with your laboratory to understand their method validation process, including the accuracy, precision, robustness, etc.
Most people consider “environmental controls” to be things like temperature and humidity control. While that is true, it can also include pest and contamination control. Poorly designed infrastructure layouts are major contributors to product cross contamination as well.
Supplier information
Undetected supply chain issues (remember the broken bottles?) can add up fast! CAPAs for suppliers cannot just include supplier monitoring, but improvement in how you communicate your needs to your suppliers. It’s easy to overlook non-cannabis raw materials as sources of microbiological and chemical contamination. Conduct a risk assessment based on the type of contact with your product and the types of contamination possible and adjust your supplier qualification program accordingly.
Are you ready to recognize the benefits of a CAPA program?
One more major benefit of CAPA programs to mention before we go is … Preventive via predictive analytics.
In Colorado, 15% of the final tested cannabis flower products continue to fail, mostly due to mold and mildew. A quality system, with effective data capture that is funneled into a CAPA program can easily reduce this by 75%. For even a small business doing $2M per year in revenue, that equates to a revenue increase of nearly $200,000 with no additional expenses.
Whether you are operating in the State of Colorado or elsewhere, a CAPA and Recall program will provide immense value. In the best case, it will uncover systemic issues; worst case, it forces you to fix mild errors. What are you waiting for?
There are many factors that can lead to the challenges people face when scaling up their processes. These challenges are not unique to the cannabis/hemp industry, but they are exacerbated by the consequences generated from decades of Reefer Madness. In my time operating in the cannabis/hemp space, 15+ years, I have seen established equipment vendors and sellers of laboratory supplies, like Sigma-Aldrich (now Millipore-Sigma), Fisher-Scientific, Cerilliant, Agilent, and others, go from reporting individuals inquiring about certified reference materials to setting up entire divisions of their companies to service the needs of the industry. Progress. But we are still a fledgling marketplace facing many challenges. Let’s look at a few specific to process scale up.
Darwin Millard will deliver a presentation on this topic during the Cannabis Extraction Virtual Conference on June 29. Click here to learn more.Equipment Availability: Lack of available equipment at larger and larger process scales can severely impact project timelines. Making not only equipment acquisition difficult, but also limiting the number of reputable equipment manufacturers you can work with.
Non-Linear Expansion: NEVER assume your process scales linearly. Perhaps one of the most avoidable mistakes during process scale up. You will quickly find that for many processes you cannot just put in a larger unit and expect a proportional increase in output. This is because as process equipment increases so to must utilities and other supporting infrastructure, but not only that, process vessel geometry, proportions, and design are contributing factors to process efficiency as your scale of operations increases.
Hazardous Material Quantities: Just as important to the process as the equipment are the solvents and reagents used. As your scale of operations increases so does your demand and production of hazardous materials; solvents including carbon dioxide (CO2), ethanol, and liquid petroleum gases (LPG) like Butane and Propane are obvious hazards, but so too are the refrigerants used in the chillers, fuels used to power generators, steam created to heat critical systems, and effluents and wastewater discharged from the process and supporting systems. Not every municipality wants thousands of gallons of flammable substances and hazardous waste being generated in their backyard…
Contractor/Vendor Misrepresentation: Finding out in the middle of you project that your contractor or equipment vendor has never set up a system at this scale before is never a good feeling. Unfortunately, contractor and vendor misrepresentation of qualifications is a common occurrence in the cannabis/hemp space.
If all this was not bad enough, all too often the consequences of improper planning and execution are not felt until your project is delayed or jeopardized due to misallocation of funds or undercapitalization. This is especially true when scaling up your production capacity. Now let’s look at some ways to avoid these mistakes.
The Rule of 10
Construction drawings for a piece of process equipment.
When scaling up your process, NEVER assume that a simple linear expansion of your process train will be sufficient. It is often the case that process scale up is non-linear. Using the Rule of 10 is one way of scaling up your process through a stepwise iterative approach. The Rule of 10 is best explained through an example: Say you are performing a bench-top extraction of a few grams and want to scale that up to a few thousand kilograms. Before jumping all the way to your final process scale, start by taking a smaller jump and only increase your bench-top process by a factor of 10 at a time. So, if you were happy and confident with your results at the tens of grams scale, perform the same process at the hundreds of grams scale, then the thousands of grams scale, tens of kilograms scale, and so forth until you have validated your process at the scale of operations you want to achieve. By using the Rule of 10 you can be assured that your process will achieve the same yields/results at larger and larger scales of operation.
Scaling up your process through an iterative approach allows you to identify process issues that otherwise would not have been identified. These can include (but by no means should be considered an exhaustive list) improper heat transfer as process vessels increase in size, the inability to maintain process parameters due to inadequately sized utilities and/or supporting infrastructure, and lower yields than expected even though previous iterations were successful. However, this type of approach can be expensive, especially when considering custom process equipment, and not every processor in the cannabis/hemp space is going to be in the position to use tools like the Rule of 10 and instead must rely on claims made by the equipment vendor or manufacture when scaling up their process.
The Cannabis/Hemp Specific Process Equipment Trap
How many times have you heard this one before: “We have a piece of process equipment tailor-made to perform X,Y,Z task.”? If you have been around as long as I have in the cannabis/hemp space, probably quite a few times. A huge red flag when considering equipment for your expansion project!
Unless the equipment manufacturer is directly working with cannabis/hemp raw materials, or with partners who process these items, during product development, there is no way they could have verified the equipment will work for its purported use.
A good example of this are ethanol evaporation systems. Most manufacturers of evaporators do not work with the volumes of ethanol they claim their systems can recover. So how did they come up with the evaporation rate? Short answer – Thermodynamics, Heat Transfer, and Fluid Mechanics. They modeled it. This much surface area, plus this much heat/energy, with this much pressure (or lack thereof), using this type of fluid, moving through this type of material, at this rate of speed, gets you a 1000-gal/hr evaporator or some other theoretical value. But what is the real rate once an ethanol and cannabis/hemp solution is running through the system?
For a straight ethanol system, the theoretical models and experimental models are pretty similar – namely because humans like alcohol – extensive real-world data for ethanol systems exist for reference in designing ethanol evaporators (more accurately described as distillation systems, i.e. stills). The same cannot be said for ethanol and cannabis/hemp extract systems. While it is true that many botanical and ethanol systems have been modeled, both theoretically and experimentally, due to prohibition, data for cannabis/hemp and ethanol systems are lacking and the data that do exist are primarily limited to bench-top and laboratory scale scenarios.
So, will that 1000-gal/hr evaporator hit 1000-gal/hr once it is running under load? That’s the real question and why utilizing equipment with established performance qualifications is critical to a successful process scale up when having to rely on the claims of a vendor or equipment manufacturer. Except this is yet another “catch 22”, since the installation, operational, and performance qualification process is an expensive endeavor only a few equipment manufacturers servicing the cannabis/hemp market have done. I am not saying there aren’t any reputable equipment vendors out there; there are, but always ask for data validating their claims and perform a vendor qualification before you drop seven figures on a piece of process equipment on the word of a salesperson.
Important Takeaways
Improper design and insufficient data regarding process efficiencies on larger and larger scales of manufacturing can lead to costly mistakes which can prevent projects from ever getting off the ground.
Each aspect of the manufacturing process must be considered individually when scaling your process train because each element will contribute to the system’s output, either in a limiting or expansive capacity.
I go further into this topic in my presentation: Challenges with Process Scale Up in the Cannabis/Hemp Industry, later this month during Cannabis Industry Journal’s Extraction Virtual Conference on June 29th, 2021. Here I will provide real-world examples of the consequences of improper process scale up and the significance of equipment specifications, certifications, and inspections, and the importance of vendor qualifications and the true cost of improper design specifications. I hope to see you all there.
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