Tag Archives: monitoring

Building An Integrated Pest Management Plan – Part 2

By Phil Gibson
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This is the second part of a series of articles designed to introduce an integrated pest management framework for cannabis cultivation facilities. To see Part One, click here. Part Three comes out next week and covers prioritization and preventative measures. Stay tuned for more!

This is Part 2: Pest Monitoring, Record Keeping, & Communications

Begin your pest identification process with a pest scouting document. You have already mapped out your facility with locations and potential access locations. For each of these pest types and room type assignments (mothers, clone, veg, flower), identify your employee scouts, their scouting methods, scouting frequency and the type of likely pest they are to search for and count.

Insect Types and Tracking Methods

Figure 1: Example Sticky Trap Scouting Map

Insect pest types include, but are not limited to, airborne flying or crawling insects, their various egg, lymph, larvae, pupal shells or immature forms. Look for trace remnants, plant damage or feces that let you know they are present in some form. If they are at the mature jumping or flying stage, this can be harder to count, but sticky traps distributed on an even basis around your rooms can make the counting process more consistent from survey to survey.

Note airflows in your rooms and fan locations so migrations can be predicted once an infestation is located.

Insects Can Be Everywhere – Crawlers & Fliers

Insects would like to be everywhere so they come in many types from the obvious flying and crawling types to root-zone microscopic, aquatic, fungal, bacterial or biofilm based. For those of you using soil or media, root-zone insects can be beneficial by digesting and breaking down organic matter into something useful for your plant’s roots (earthworms) or harmful by feeding directly on your plant roots and sucking the life out of your plants from out-of-sight below (nematodes, maggots).

Common pests in a cannabis environment include:

  • White flies – Oval shaped eggs on the underside of leaves, nymphs- oval crawlers that suck on the undersides of leaves, larger stage nymphs with pupae shells as they form wings and mature white flies.
  • Fungus gnats – Clear eggs deposited in overly wet soil or dead plant matter. Clear or white colored larvae in the soil or media, these worm-like critters go through multiple stages of molting as they grow, eventually pupating into brown cocoons and finally small black or dark flies with clear wings that flutter around your plants and suck on your leaves.
  • The dreaded spider mite – Clear, hard to see eggs on the underside of your leaves. These six-legged tiny moving bubbles begin the feeding as larva, add 2 legs in the intermediate and mature nymph stages and finally the oval shaped spider mites that every grower despises, adding their webs around the tops of your plants as their nurseries suck the life out of your flowers.

Insect Transfers of Bacterial Infections

Figure 2: The Dreaded Spider Mite

Many crawlers or fliers you may discover in your grow operation do not generate fungus or bacteria on their own. However, they do routinely pick these up along the feeding way and bring them into your shop. Sap-feeding insects like leafhoppers and aphids use their needle mouths to pierce your leaves to suck on the sap that is nourishing your greenery. These insects consume the fluids and transfer bacteria as they feed. Whiteflies fit into this category of leaf sucking bacteria carrying pests. These pests can make your healthy grow rooms look blotchy with color drained out of your canopy.

Obvious symptoms of these flying/hopping pests are sticky leaves, black fungus mold, or yellowing leaves that show up at the bottom of your plants and work their way upward as the infestation progresses. Leaf curling or plant wilting will be visible in the more advanced stages of these pests.

As if crawlers were not bad enough, invisible fungus and bacteria that get into your water supplies can be the worst challenges of any grow.

Water Sourced Bacteria

Baseline testing of your feed water is critical for any facility. This is true whether you are using surface water, well water or municipal water. Please see the water tutorials on the AEssenseGrows website for details on how to test your water sources and what to look for in the mineral content.

Regardless of your water source, bacteria can be present directly in your water supply, or it can be introduced from infected plant materials from one of your suppliers. Pythium, fusarium and the latest plague, hop latent viroid, are some of the most common threats that attack your plants from your water or soil sources. These can come from your wells, feed lines or plant materials.

Reverse osmosis (RO) is a typical method to clear water of most pathogens and bacteria using water that is pressed through filters with very small membrane apertures. These small openings usually stop impurities, salts and microorganisms. Of course, these systems come in many different types and they have to be maintained to keep their performance quality. Don’t take shortcuts on your RO system.

Once your water source is clean, strict hygiene procedures for tools, equipment and plumbing are the best way to minimize these threats to your plants downstream from your water source. These cleaning efforts are not a guarantee. Pests can still get into even the best facilities. Symptoms of these maladies vary, but root rot, stunted growth, wilting, discolored roots or leaves, and in some cases, the quick death of your plants is possible depending on the critter.

Use your scouting regimen and your data mapping to locate infestations before they expand and damage your facility. Isolate outbreaks and take appropriate measures to address the pests. We will give you suggestions on prioritization and preventative measures to take in the next chapter.

Figure 3: Example Pythium Brown Roots

Pythium is one of the most commonly harbored soil or water carried pests. When it is present and gets into your plants through cuts, natural openings, root surfaces or leaves on weakened plants, it can be devastating. In hydroponic systems, dirty looking brown roots evolve into full root rot if not addressed. Pythium is often the cause. In soil operations, pythium often shows up as wilting or yellowing patches on leaves.

Your lab testing partners are your friends when it comes to bacterial or fungal infections. Many diseases can resemble one another. It is not hard to misdiagnose environmental stress such as overheating or overwatering for a bacterial problem. Test results are necessary to accurately diagnose a problem.

Truly Airborne Molds & Mildews

Pythium and fusarium are not just present in water. They can also be airborne. Grey mold (botrytis) and powdery mildew are also common airborne pests. Proper humidity, air movement, air filtration and sterilization using HEPA (High-Efficiency Particulate Air) filters, activated carbon filters (also filter smells) and UV light sterilization can minimize these problems in your grow. Powdery mildew is the primary evil spore in this category. Airflow and regular cleaning to discourage fungal growth is the best way to limit these pests.

In conclusion, this week

Now that we have talked about identification (and clearly, this is not an exhaustive list), we will move into how to build in the cultural methods to prevent these problems from taking hold and ruining your business. In later chapters, we will dive into prioritization, treatment and control options for infestations, finally moving into control actions and emergency response.

Your integrated management response is how you pull all of this together and use your IPM procedures to increase your profitability. For the complete white paper on Integrated Pest Management Recommendations, download the document here.

Part three comes out next week and will delve into the world of Preventative Measures. Stay tuned for more!

Building An Integrated Pest Management Plan – Part 1

By Phil Gibson
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This is the first part of a series of articles designed to introduce an integrated pest management framework for cannabis cultivation facilities. Part one details an overview of the plan as well as pest identification. Part two comes out next week and will delve into the world of pest monitoring and record keeping. Stay tuned for more!

Figure 1: Integrated Pest Management Cycle

Background

Integrated Pest Management (IPM) is a philosophy of pest prevention and control that integrates cultural, mechanical, physical and chemical practices to control pest populations within an acceptable degree of economic tolerance.

IPM encourages growers to take a step-wise approach to determine the most appropriate means necessary for avoiding pest-related economic injury through careful consideration of all available pest control practices.

When practicing IPM, less invasive non-chemical practices are given priority, until escalation necessitates otherwise.

This is Part 1: Pest Identification & Monitoring/Communications

Personal experience in a facility is a great place to start. Review your history and identify a list of pests that you have experienced in this or previous grows. Point out which pests currently exist where they were or are currently and possible sources of the contamination/infestation.

Figure 2: Healthy Aeroponic Mother Stock

Map out your facility with clear entry/exits, plumbing & drainage and air flow access to visually see and understand potential access points for crawling, flying or airborne pests.

From your nursery mother room to cloning and vegetation areas, what are the transfer methods as you move from one area to another. Are pests present in these areas? Where could they have come from? Oftentimes, a cultivator may not have the space for their own mother and cuttings/cloning space. In these cases, where did the outsourced clones come from? What are the IPM controls in place for these genetic sources? Are they carriers of the challenges transferred to your own facility? It is important to identify the possible source of pest potentials

Does your flower room have white flies or fungus gnats? Locating these and identifying the likely source is a good place to start if you have an ongoing infestation.

Figure 3: Example Aeroponic Facility Layout For IPM Planning

Powdery mildew is a routine challenge if air into your facility is not filtered and sterilized to eliminate these spores.

What is the Source of Your Irrigation/Fertigation Water?

Water is a crucial element for high-value indoor farms such as those that grow cannabis. However, water can also be a source of disease-causing microorganisms that can negatively impact the growth and yield of crops. Monitoring, filtering and sterilizing the biological contents of water is therefore crucial in ensuring the health and quality of high-value crops.

Unfiltered water can contain a range of pathogens such as bacteria, viruses, fungi and parasites that can cause root, stem and bud rot. These diseases can cause significant losses in crop yield and quality, which can be devastating for indoor farmers growing high-value crops.

Figure 4: Precision Aeroponics at FarmaGrowers GMP Facility, South Africa

Monitoring the quality of water that is brought into the indoor farm is the first step in ensuring that the water is free from harmful pathogens. This involves regular testing of the incoming water for parameters such as pH, dissolved oxygen, TDS, nutrient content and microbial load. This allows cultivators to identify aspects of the incoming water they need to address before the water is provided to their crops to prevent potential problems.

Is your plumbing building biofilm that is feeding into your irrigation lines? Obviously, there are many potential sources when you go through an inventory of the risks for your facility. From that initial step, you will build your management team and label who should be contacted when a pest is found. Do you have an IPM specialist or is this a resource that needs to be contracted to address an infection?

Building this communications tree is your first step to fewer pest issues and higher yields and potency.

For the complete white paper on Integrated Pest Management Recommendations, download the document here. Part two comes out next week and will delve into the world of pest monitoring and record keeping. Stay tuned for more!

The 3-Legged Stool of Successful Grow Operations: Climate, Cultivation & Genetics – Part 4

By Phil Gibson
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This is Part 4 in The 3-Legged Stool of Successful Grow Operations series. Click here to see Part 1, here to see Part 2, and here to see Part 3. Stay tuned for Part 5, coming next week.

Integrated Pest Management (IPM)

Aeroponic & hydroponic systems can operate with little to no soil or media. This eliminates the pest vectors that coco-coir, peat moss/perlite and organic media can harbor as part of their healthy biome approach. Liquid nutrient systems come at the nutrient approach from a different direction. Pure nutrient salts (nitrogen, potassium, magnesium and trace metals) are provided to the plant roots in a liquid carrier form. This sounds ideal for integrated pest management programs, but cultivators have to be aware of water and airborne pathogens that can disrupt operations. I will summarize some aspects to consider in today’s summary.

The elimination of soil media intrinsically helps a pest management program as it reduces the labor required to maintain a grow and the number of times the grow room doors are opened. Join that with effective automation with sensors and software, and you have immediate improvements in pest access. Sounds perfect, but we still have staff to maintain a facility and people become the number one source of contamination in a grow operation.

Figure 1: Example of Pythium Infected & Healthy Roots

Insects do damage directly to plants as they grow and procreate in a grow room. They also carry other pathogens that infect your plants. For example, root aphids, a very common problem, are a known carrier of the root pathogen, Pythium.

Procedures

One of the most common ways for pests to access your sealed, sterile, perfectly managed facilities are in the root stock of outsourced clones. If you must start your grow cycles with externally sourced clones, it is strongly recommended that you quarantine those clones to make sure that they do not import pest production facilities into your operation. Your operation management procedures must be complete. If you take cuttings from an internal nursery of mother plants, any pathogens present in your mother room will migrate through cuttings into your clones, supply lines, and subsequently, flower rooms.

Figure 2: Healthy Mothers & Clones, Onyx Agronomics

Start your gating process with questioning your employees and visitors. Do they grow at home or have they been to another grow operation in the last week? In the last day? You may be surprised by how many people that gain access to your grow will answer these questions in the affirmative.

Developing standard operating procedures (SOPs) that are followed by every employee and every visitor will significantly reduce your pest access and infection rates, and hence, increase your healthy harvests and increase your profitability. Procedures should include clothing, quarantining new genetics and cleaning procedures, such as baking or irradiating rooms to guarantee you begin with a sterile facility. This is covered more in the complete white paper.

Engineering Controls

Figure 3: Access Control: Air Shower, FarmaGrowers

Technology is a wonderful thing but no replacement for regimented procedures. Considered a best practice, professional air showers, that bar access to internal facilities, provide an aggressive barrier for physical pests. These high velocity fan systems and exhaust methods blow off insects, pollen and debris before they proceed into your facility. From that access port into your grow space, positive air flow pressure should increase from the grow rooms, to the hallways, to the outside of your grow spaces. This positive airflow will always be pushing insects and airborne material out of your grow space and away from your plants.

Maintaining Oxidation Reduction Potential (ORP)

ORP is a relative measurement of water health. Perfect water is clear of all material, both inert and with life. Reverse osmosis (RO) is a standard way to clear water but it is not sufficient in removing microscopic biological organisms. UV and chemical methods are needed in addition to RO to clear water completely.

ORP is an electronic measurement in millivolts (mV) that represents the ability of a chemical substance to oxidize another substance. ORP meters are a developing area and when using a meter, it is important to track the change in ORP values rather than the absolute number. This is due to various methods that the different meters use to calculate the ORP values. More on this in the white paper.

Oxidizers

Figure 4: AEssenseGrows Aeroponic Nozzles

There are two significant ways to adjust the ORP of a fertilizer/irrigation (fertigation) solution. The first is by adding oxidizers. Examples are chemical oxidizers like hydrogen peroxide (H2O2), hypochlorous acid (HOCl), ozone (O3) and chlorine dioxide (ClO2). Adding these to a fertigation solution increases the ORP of the fertigation solution by oxidizing materials and organic matter. The key is to kill off the bad things and not affect the growth of plants. Again here, the absolute ORP metric is not the deciding factor in the health of a solution and the methods by which each chemical reaction occurs for each of these chemicals are different. This is compounded by the fact that different ORP meters will show different readings for the same solution.

Another wonderful thing about automation and aeroponic and hydroponic dosing systems is that they can automatically maintain oxidizing rates and our white papers explain the methods executed by today’s automation systems.

Water Chilling

Another way to adjust ORP is to reduce the water temperature of the reservoirs. Maintaining water temperature below the overall temperature of your grow rooms is imperative for minimal biological deposition and nutrient system health. Water chillers use a heat exchanger process to export heat from liquid nutrient dosing reservoirs and maintain desired temperatures.

The benefit of managing ORP in aeroponic and hydroponic grow systems is highly accelerated growth. This is enhanced in aeroponics due to the effectively infinite oxygen exchanging gases at the surface of the plant roots. Nutrient droplets are sprayed or vaporized in parallel and provided to these root surfaces. Maximizing the timing and the best mineral nutrients to the root combustion is the art of grow recipe development. Great recipes drive superior yields and when combined with superior genetics and solid environmental controls, these plants will deliver spectacular profits to a grow operation.

Another Hero Award

Before closing this chapter, we have many cultivators that are producing stellar results with their operational and IPM procedures, so it is hard to choose just one leader. That said, our hats are off to RAIR Systems again and their director of cultivation, Ashley Hubbard. She and her team are determined to be successful and drive pests out of their operations with positive “little critters” and the best water treatment and management that we have seen. You are welcome to view the 7-episode walkthrough of the RAIR facility and their procedures here.

To download the complete guide and get to the beef quickly, please request the complete white paper Top Quality Cultivation Facilities here.

Stay tuned for Part 5 coming next week where we’ll discuss Genetics.

cannabis close up

Benefits To Growing Cannabis In A Cleanroom Environment

By Steve Gonzales
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cannabis close up

For commercial cannabis growers, consistent crop yields are vital to maintaining product profitability, as well as durable profitability. Since cannabis thrives under certain conditions, the more control a cultivator has over those conditions, the easier consistent harvests become.

While factors like humidity, light exposure and water may be easy enough to control in any indoor environment, other influential factors can be more difficult to control, such as mold or other contaminants. Growing in a controlled cleanroom environment ensures healthy, high-quality cannabis by mitigating some harder-to-control threats. For these reasons, growing cannabis in a cleanroom environment is rapidly becoming the gold standard in the industry.

A Closer Look at the Cleanroom Environment

A cleanroom facility is a specially designed room or modular addition designed to support a tightly controlled grow environment for crops. The design of the cleanroom relies on several design features to deter issues with pollutants, such as insects, mold, airborne microbes and dust. Even though cleanroom environments are often affiliated with cultivating certain types of crops, these facilities are also valuable in other industries, such as medicine, biology and pharmaceuticals.

Cleanrooms can be conservatively sized or massive. They can be configured to accommodate different processes, and they can be built to suit a specific grower’s preferences. However, several features are key, such as:

  • Cleanroom-rated HEPA (high-efficiency particulate arrestor) filtration
  • Contamination control mats
  • Positive-pressure airflow systems
  • Double-door air chambers at entry points
  • Moisture-resistant wall panels
control the room environment
Preventing contamination can save a business from extremely costly recalls.

One fundamental requirement of a cleanroom is to control the introduction of contaminants into the space. Contaminants can be carried in on the people who visit the space. Therefore, cleanroom implementation must come along with strict protocols when it comes to employee entry into the room. For example, air showers, special gowns, masks and other measures may be required. 

The Benefits of Cleanroom Environments for Cultivators

On the surface level, cleanrooms make it possible to achieve a well-controlled environment for cannabis cultivation. However, while this is undeniably important in terms of consistent crop yields and profitability, cleanrooms pose a number of broader advantages for cultivators and end customers.

Meet Laboratory Testing Guidelines and Protocols

For now, states create product testing regulations for cannabis. Most states that have legalized medical or adult use cannabis have created protocols for lab-testing products for pesticides and microbes. When batches of cannabis product do not meet state lab-testing standards, the product can be recalled or destroyed. In 2016, Steep Hill published an alarming study that showed they detected pesticides in roughly 70% of the samples they received and up to one third of all samples would have failed to meet regulatory standards. Cleanrooms reduce a grower’s reliance on pesticides.

Negate the Risk of Fungal Contamination

Cleanrooms negate the risk of fungal contamination through proper ventilation, particulate control and positive pressure.

Cannabis is prone to certain types of fungal spores that can cause severe illness in end customers. For example, Aspergillus mold spores are common in cannabis and can lead to cases of chronic pulmonary aspergillosis. In large doses, Aspergillus mold spores may even cause liver failure due to the carcinogenic mycotoxins the spores produce in the body. Cleanrooms negate the risk of fungal contamination through proper ventilation, particulate control and positive pressure. 

Create a Safer Work Environment for Employees

Employees who work in cultivation facilities in the cannabis industry face various occupational hazards. Many of these hazards are related to being in contact with fungicides, mold spores and chemical fertilizers. The exposure can result in issues such as allergic reactions, respiratory irritation and other physical threats. Cleanrooms and how they function can deter many of these risks. For example, the lack of need for fungicide use automatically lowers the risks due to lacking exposure. Further, because protective gear is required to maintain the integrity of the cleanroom, there is less of a chance an employee’s skin or respiratory system is exposed to irritants.

Cleanrooms: The Potential Future of Cannabis Cultivation

As cannabis becomes a more robust industry and regulations become more clearly defined, growing standards are bound to change. As speculations of national regulations veer closer to reality, growing cannabis industrially may even mean required cultivation facility upgrades. Cleanroom environments give growers firm control over the health of their crops while ensuring clean products for customers. Therefore, these innovative and health-forward implementations could easily become the norm in the cannabis industry in the future.

The 3-Legged Stool of Successful Grow Operations: Climate, Cultivation & Genetics – Part 1

By Chris Wrenn, Phil Gibson
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Ideal cannabis profits come from high demand/high selling prices and low production costs. The spread between those two, or margin, can determine the life or death of your business. We want to share this series of articles so that your next investment can be highly successful and high margin out-of-the-box.

Regardless of the grow method (soil, coco, rockwool, hydro or aero), every plant performs best in its own ideal environmental conditions. Experienced growers gained success through hard work, and just that, experience. Many have tried more advanced grow technologies, but shied away due to early trial failures or the complexity of maintaining chemistry across a grow facility. The wonderful thing now is that precision sensors and software controls eliminate the risk to robust healthy plants and harvest success. Growers are now able to both manage production while performing research in line with their operations.

We have learned a great deal working with our grow partners over the last 6 years. Every grow facility and location are different due to local weather, business environment and scale. This series of articles and guide, authored by our expert, Christopher Wrenn, will include recommendations of the most successful approaches we have seen here in North America and all over the world.

A 4-Layer fully aeroponic flower room using movable racking systems

Building top-quality cultivation facilities is no simple task. Cultivators are also looking for new help as they shift from older soil or media approaches to more efficient grow methods. One powerful method is aeroponics, which is very good at growing any type of plant in air in a sterile environment, with labor, nutrient and water savings.

Where possible, we will share key vendors that support healthy grow operations and (since it is World Series Time), customer examples that are knocking it out of the park. In today’s competitive business environment, it is critical to do what we can to increase profitability and survival in the face of steep headwinds. We want you to crush it and be “the last man standing.”

So, let’s get to it.

Climate: Environmental Control

We begin with a critical leg in your environment. The process of photosynthesis is more than just light, plant and moisture. We want to do more than just grow plants. We want to grow highly profitable plants. That means we have to accelerate photosynthesis so we are growing faster, bigger and more potent than our competitors.

The Vapor Pressure Deficit (VPD) is the amount of “drying power” available in the air surrounding your plants. This is a useful way to understand the amount of moisture your atmosphere can remove from your plants as they digest carbon dioxide and aspirate water and oxygen into the air around your plants. A higher vapor deficit is a good thing for growth; It is also a measurement of how much nutrient you can uptake into the plant roots and convert into size and potency in the canopy. We recommend that you have resources in your grow rooms to maintain your environment to within 5% of both your humidity and temperature targets for ideal results.

Onyx Agronomics is a Tier 3 indoor cultivator in the State of Washington. This is the canopy in one of their 8 flower rooms.

In our Top Quality Cultivation Facility white paper, we review environmental settings for temperature and humidity for mother, clone/veg and flower rooms for day and night light cycles from early cuttings through to end of harvest flush. Day temperatures can be up to 20% higher than night temperatures for example.

Cooling

Managing temperature may seem straight-forward but the heat generated by LED lights, HPS lights or the sun will vary across rooms, time exposure and with the distance of the light source from the plants. Measurement sensors should be distributed across rooms to monitor and trigger temperature resources.

Humidification/Dehumidification

This is a topic that can be underappreciated by cultivators. It is important to slowly transition humidity as you move plants from cuttings to clones, to veg and to flower. Beginning in a very humid stage to motivate root start, humidity will be stepped down from an opening near 90% down to an arid 50% in your end of flush flower rooms. We detail the transitions in 5% increments in the white paper.

The 4-Layer aeroponic flower room with movable racking systems from the side with a tall human for scale. One can do a lot with 30′ ceilings.

Relative Humidity (RH) and the related VPD are the key metrics to accelerating growth throughout the stages. Not sizing dehumidifiers correctly is one of the most common mistakes our grow partners learn about as they move to full production. In the first phase of turning cuttings from healthy mothers into rooted clones, hitting your target VPD to motivate root growth is the number one success factor. This will require the addition of humidity into your clone room. It is also typical to require raise the humidity of your flower rooms when you transition clone/veg plants from the high humidity clone/veg room into an initially dry flower room, otherwise the plants may go into shock as a result of the dramatic change.

As flowering begins, if humidity remains high, and the VPD is below target, the plants will not be moving nutrients and transpiring moisture. We have seen lowering the humidity from 70% in a flower room down to 50%, results in a yield increase from 50 grams to 90 grams of dry trim bud per plant, so a smooth transition can both accelerate growth and have a big impact on your margins and profitability.

Plants in aeroponics can truly have explosive growth. This means that they will also transpire moisture at an accelerated rate. Fast automated growth in aeroponics means increased humidity output. Sizing these critical systems for humidification/dehumidification are a critical part of the design process.

Airflow

Fans combined with your cooling/heating/humidity/dehu systems need to mix the air in a room to break the boundary layer at the leaf surface for transpiration. As we covered, VPD is critical to growth success. A dry surface motivates the plants to transpire moisture. We recommend flow rates across the canopy in a 0.5-1.5 meter/second rate to align to your genetics and where you are in the flowering process.

A raw facility before it gets outfitted.

Airflow and flowering means rich beautiful aromas are generated. Every facility has to consider odor control. If you are in a populated area, you will have ordinances and neighbors to satisfy. The best way to do this is to minimize the amount of air that exits a facility. This is also the cheapest approach.

Sterile HEPA filters and scrubbing systems clean air of pathogens and odor but they also need to circulate and “condition” air to the correct temperature and humidity levels before it can be recirculated into a room. Oftentimes, this is a good place to also recapture humidity and reinject it into your pure water cleaning systems.

Key vendors to talk to about sizing air treatment systems are SURNA, Quest, Desert Aire and AGS. Each of these vendors have specialties and tend to be superior partners in different regions of the world. We would be happy to introduce you to excellent support resources for air management systems.

To download the complete guide and get to the beef quickly, please request the complete white paper Top Quality Cultivation Facilities here.

Click here to see Part 2 where we discuss water quality and management.

Cannabis Manufacturing Considerations: From Raw Materials to Finished Goods

By David Vaillencourt, Kathleen May
2 Comments

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.

  1. 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 Tests 3and 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 Conductivity 6.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.

  1. 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.

  1. HVAC
urban-gro
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.

  1. 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.

  1. 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).

  1. 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 Symbols 27.

  1. 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 Systems 16 and/or UL 2017, Standard for General-Purpose Signaling Devices and Systems 17 and UL 2075, Standard for Gas and Vapor Detectors and Sensors 18.

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:

  1. United States Environmental Protection Agency (EPA) Safe Drinking Water Act (SDWA).
  2. United States Pharmacopeia (USP) Chapter <1231>, Water for Pharmaceutical Purposes.
  3. United States Pharmacopeia (USP) Chapter <61>, Testing: Microbial Enumeration Tests.
  4. United States Pharmacopeia (USP) Chapter <62>, Testing: Tests for Specified Microorganisms.
  5. United States Pharmacopeia (USP) Chapter <643>, Total Organic Carbon.
  6. United States Pharmacopeia (USP) Chapter <645>, Water Conductivity.
  7. ASTM E108 -11, Standard Test Methods for Fire Tests of Roof Coverings.
  8. UL 790, Standard for Standard Test Methods for Fire Tests of Roof Coverings.
  9. International Building Code (IBC).
  10. International Fire Code (IFC).
  11. National Fire Protection Association (NFPA).
  12. National Electrical Code (NEC).
  13. Institute of Electrical and Electronics Engineers (IEEE).
  14. National Electrical Safety Code (NESC).
  15. International Energy Conservation Code (IECC).
  16. UL 864, Standard for Control Units and Accessories for Fire Alarm Systems.
  17. UL 2017, Standard for General-Purpose Signaling Devices and Systems.
  18. UL 2075, Standard for Gas and Vapor Detectors and Sensors.
  19. International Society for Pharmaceutical Engineers (ISPE) Good Practice Guide.
  20. International Society for Pharmaceutical Engineers (ISPE) Guide Water and Steam Systems.
  21. ISO 8573:2010, Compressed Air Specifications.
  22. ISO 22196:2011, Measurement Of Antibacterial Activity On Plastics And Other Non-Porous Surfaces.
  23. D8205 Guide for Video Surveillance System.
  24. D8217 Guide for Access Control Syst
  25. D8218 Guide for Intrusion Detection System (IDS).
  26. National Cannabis Industry Association (NCIA): Committee Blog: An Introduction to HVACD for Indoor Plant Environments – Why We Should Include a “D” for Dehumidification.
  27. NFPA 170, Standard for Fire Safety and Emergency Symbols.

3 Pillars of Cannabis Banking Compliance

By Mark Lozzi
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Few people will disagree that financial compliance isn’t the most exciting topic within the cannabis industry. But compliance is, and always will be, the engine grease to the legal cannabis market. Cannabis operators have the arduous task of dealing with multiple layers of compliance, both operational (maintaining and adhering to regulations enforced by the state licensing board) and financial. These compliance measures include managing everything from seed-to-sale systems for all plant-related activity to on-site requirements like facility access points and alarms systems to name a few.

With complex compliance requirements for the business, the last thing cannabis operators want to think about is financial compliance. We created Confia on this notion. Just as cannabis regulators impose the tracking of plants through the supply chain via a seed-to-sale system, we have developed a storyboard similarly designed to follow the money, which is the equivalent of a transaction-to-deposit system.

Having experience in regulatory technology, artificial intelligence and machine learning, we’ve been fortunate enough to work with some of the world’s largest banks across multiple countries. This experience has afforded us the luxury of working alongside regulators, chief compliance officers and chief risk officers, understanding how risk is perceived by financial institutions and how it ought to be mitigated. It was this access and knowledge that allowed us to effectively reform, enhance and improve the antiquated BSA programs with a technology-enabled process. Leveraging technology is a necessity, almost a requirement, for the cannabis industry as legalization nears and banking access begins to broaden.

Jamming cannabis requirements into an existing BSA program doesn’t scale well. BSA programs are very manual, descriptive and process oriented. So, we’ve taken our prior experience and success in banking to form Confia, distilling the complexities and simplifying the deliverables surrounding cannabis banking compliance. To best articulate cannabis banking requirements, I break it down into three pillars.

Pillar One: KYC-Enhanced Due Diligence

The first pillar is the client-onboarding bucket or KYC – Know Your Customer. In the complex world of cannabis banking, banks must know and understand their clients to great depths. It’s not enough to simply know that the client exists; you also have to understand whether or not that client could be a potential risk to the bank, and one step further, the financial system. Cannabis is a high-risk industry, so the KYC requirement is escalated to a deeper diligence and review, called Enhanced Due Diligence (EDD).

Cannabis is a high-risk industry so extra due diligence is needed

Banks need to know and understand their customers’ story, and all the key parties (officers, directors, and those with key decision-making powers or access to the bank accounts) within that organization. This includes reviewing personal, business, and legal history – not to mention watchlists and negative news presence. An initial onboarding review must then be followed with daily screening and monitoring of all watchlists and adverse media. Typically, banks do KYC refreshes every three years. In cannabis, a full refresh should be done annually with the daily monitoring systems in place.

The high-risk nature of the industry also requires a level of diligence on all parties to a transaction, even if one of the parties, whether a payer or recipient, is not a client of your bank. Unlike traditional banking sectors, reliance on other banks’ KYC programs is far less defensible in the cannabis industry.

Pillar Two: Transactional Monitoring & Detection

Tracking and monitoring the actual financial transactions comprises the second pillar required for cannabis banking. At Confia, we have focused on streamlining processes, so the cannabis operator can seamlessly support the compliance obligation for every transaction. A bank must demonstrate supporting documentation for every cannabis transaction, and gathering such information is a large undertaking in and of itself and can pose future issues if not done properly, see the pitfalls for lack of compliance. Banks are obligated to understand the nature and reason for each transaction, the source of funds, ensure cannabis licenses are in good standing for all parties, and collect evidence such as accounting records and seed-to-sale data.

Core to transaction monitoring in the traditional sense, is the overarching support through anomaly detection. Relying on information is important, but testing those inputs keeps everyone honest. It is important to evaluate transactions from a holistic point of view relative to peers and relative to the general contents of a transaction. This anomaly detection layer is your last line of defense, and as new information is collected, it continues to refine itself.

Pillar Three: Filing and Reporting Requirements

The third component to compliant cannabis banking is regulatory filing and reporting. Once a client is onboarded, the account requires an initial suspicious activity report or SAR-Initial within 30 days of that client being approved by the bank. Then, a report must be filed every 90 days after that for all the transactions of that cannabis operator. Banks must file the SAR-Initial and the Continuing-SAR reports for each cannabis client they have.

The high-risk nature of the industry requires a level of diligence on all parties to a transaction

Solutions like Confia automate the filing process and support the filing with transactional data evidenced on our distributed ledger of record. This provides immutable audibility and simplifies the process for all parties involved.

Compliance Requirements After US Legalization

The anticipation of federal legalization and banking reform bills has many operators hoping for easier banking. Yet, in my opinion, regulatory oversight and audits will likely increase after such reform or legalization. As other financial institutions start to support cannabis, it will inadvertently create greater opportunity and expose the financial system to nefarious or illegitimate transaction activity. This is why cannabis banking will be carefully monitored by regulators, and more so, why banks will be slow and pragmatic in standing up their internal cannabis banking programs. Some banks may forever avoid the cannabis industry due to the known pitfalls of an industry specific program, while others may simply mitigate the possible exposure to reputational risk.

Choose Wisely: Pitfalls for Lack of Compliance

Financial compliance is the responsibility and duty of the banks, but the real losers and result of non-compliance always fall on the cannabis operators. Regulatory action against an institution may result in the bank shutting down its cannabis program or may require them to complete a remediation of all their cannabis transactions for a certain period from its clients. At the end of the day, regardless of action, the cannabis operator is the one being punished. Operators either lose their bank account and have business massively disrupted, or they are asked to provide all the compliance docs for a historic period, which is a huge undertaking and operational distraction, ultimately impacting business and productivity. So, choose your banking partner wisely.

Summarizing Key Banking Requirements

In summary, banking in the cannabis industry will undoubtedly remain a high-risk industry, with or without legalization. Although banking opportunities may expand as US policies change, there will be continued compliance and regulatory requirements for the foreseeable future.

  • Onboarding and ongoing screening are critical
  • Evidence for every transaction is a significant portion of compliance and must not be dismissed
  • Evaluating activity with broader strokes is essential in mitigating against money laundering
  • Managing the staggered filing timelines and due dates for each client

Compliance is the most crucial factor in cannabis banking at this point. It cannot be overlooked or taken for granted. Cannabis operators must take an active role in evaluating the compliance programs of their financial providers. To open a bank account is one thing, but the consideration and effort that goes into keeping a bank account is the difference that will protect your business in the long run.

Leaders in Cannabis Testing – Part 1: A Q&A with Milan Patel, CEO and Co-Founder of PathogenDx

By Aaron Green
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In this “Leaders in Cannabis Testing” series of articles, Green interviews cannabis testing laboratories and technology providers that are bringing unique perspectives to the industry. Particular attention is focused on how these businesses integrate innovative practices and technologies to navigate a rapidly changing landscape of regulatory constraints and B2B demand.

PathogenDx is an Arizona-based provider of microbial testing technologies. Since their inception in 2014, they have broadened their reach to 26 states in the US. In addition to cannabis product testing, PathogenDx also provides technologies for food safety testing, environmental testing and recently started offering human diagnostics testing to support COVID-19 response efforts.

We interviewed Milan Patel, CEO and co-founder of PathogenDx. Milan founded PathogenDx as a spin-off from one of his investments in a clinical diagnostics company testing for genetic markers in transplant organs. Prior to PathogenDx, Milan worked in finance and marketing at Intel and later served as CFO at Acentia (now Maximus Federal).

Aaron Green: What’s the history of PathogenDx?

Milan Patel: PathogenDx was effectively a spin-off of a clinical diagnostics company that my partner Dr. Mike Hogan, the inventor of the technology, had founded when he was a professor at the University of Arizona, but previously at Baylor Medical College back in 2002. I had invested in the company back then and I had realized that his technology had a broad and wide sweeping impact for testing – not just for pathogens in cannabis specifically, but also for pathogens in food, agriculture, water and even human diagnostics. In the last 14 months, this became very personal for every single person on the planet having been impacted by SARS-CoV-2, the viral pathogen causing Covid-19. The genesis of the company was just this, that human health, food and agricultural supply, and the environment has and will continue to be targeted by bacterial, fungal and viral pathogens impacting the safety and health of each human on the planet.

We founded PathogenDx and we pivoted the company from its original human organ transplant genetics market scope into the bigger markets; we felt the original focus was too niche for a technology with this much potential. We licensed the technology, and we repurposed it into primarily cannabis. We felt that achieving commercial success and use in the hands of cannabis testing labs at the state level where cannabis was first regulated was the most logical next step. Ultimately, our goal was and is to move into markets that are approved at the federal regulatory side of the spectrum, and that is where we are now.

Green: What year was that?

Milan Patel, CEO and Co-Founder of PathogenDx
Photo credit: Michael Chansley

Patel: 2014.

Green: So, PathogenDx started in cannabis testing?

Patel: Yes, we started in cannabis testing. We now have over 100 labs that are using the technology. There is a specific need in cannabis when you’re looking at contamination or infection.

In the case of contamination on cannabis, you must look for bacterial and fungal organisms that make it unsafe, such as E. coli, or Salmonella or Aspergillus pathogens. We’re familiar with recent issues like the romaine lettuce foodborne illness outbreaks at Chipotle. In the case of fungal organisms such as Aspergillus, if you smoke or consume contaminated cannabis, it could have a huge impact on your health. Cannabis regulators realized that to ensure public health and safety there was more than just one pathogen – there were half a dozen of these bugs, at a minimum, that could be harmful to you.

The beauty of our technology, using a Microarray is that we can do what is called a multiplex test, which means you’re able to test for all bacterial and fungal pathogens in a single test, as opposed to the old “Adam Smith” model, which tests each pathogen on a one-by-one basis. The traditional approach is costly, time consuming and cumbersome. Cannabis is such a high value crop and producers need to get the answer quickly. Our tests can give a result in six hours on the same day, as opposed to the two or three days that it takes for these other approved methods on the market.

Green: What is your business model? Is there equipment in addition to consumables?

Patel: Our business model is the classic razor blade model. What that means is we sell equipment as well as the consumables – the testing kits themselves.

The PathogenDx technology uses standard, off-the-shelf lab equipment that you can find anywhere. We didn’t want to make the equipment proprietary so that a lab has to buy a specific OEM branded product. They can use almost any equipment that’s available commercially. We wanted to make sure that labs are only paying a fraction of the cost to get our equipment, as opposed to using other vendors. Secondly, the platform is open-ended, meaning it’s highly flexible to work with the volumes that different cannabis labs see daily, from high to low.

One equipment set can process many different types of testing kits. There are kits for regulated testing required by states, as well as required environmental contamination.

Green: Do you provide any in-house or reference lab testing?

Patel: We do. We have a CLIA lab for clinical testing. We did this about a year ago when we started doing COVID testing.

We don’t do any kind of in-house reference testing for cannabis, though we do use specific reference materials or standards from Emerald Scientific, for example, or from NCI. Our platform is all externally third-party reference lab tested whether it’s validated by our external cannabis lab customers or an independent lab. We want our customers to make sure that the actual test works in their own hands, in their own facility by their own people, as opposed to just shrugging our shoulders and saying, “hey, we’ve done it ourselves, believe us.” That’s the difference.

Green: Can you explain the difference between qPCR and endpoint PCR?

Patel: The difference between PathogenDx’s Microarray is it uses endpoint PCR versus qPCR (quantitative real time PCR). Effectively, our test doesn’t need to be enriched. Endpoint PCR delivers a higher level of accuracy, because when it goes to amplify that target DNA, whether it’s E. coli, Salmonella or Aspergillus pieces, it uses all the primer reagent to its endpoint. So, it amplifies every single piece of an E. Coli (for example) in that sample until the primer is fully consumed. In the case of qPCR, it basically reaches a threshold and then the reaction stops. That’s the difference which results in a much greater level of accuracy. This provides almost 10 times greater sensitivity to identify the pathogen in that sample.

The second thing is that we have separated out how the amplified sample hybridizes to the probe. In the case of our assay, we have a microarray with a well in it and we printed the actual probe that has the sequence of E. coli in there, now driving 100% specificity. Whereas in the qPCR, the reaction is not only amplifying, but it’s also basically working with the probe. So, in that way, we have a higher level of efficiency in terms of specificity. You get a definite answer exactly in terms of the organism you’re looking for.

In terms of an analogy, let’s take a zip code for example which has the extra four digits at the end of it.  In the case of endpoint PCR, we have nine digits. We have our primer probes which represent the standard five digits of a zip code, and the physical location of the probe itself in the well which serves as the extra four digits of that zip code. The analyte must match both primary and secondary parts of the nine-digit zip code for it to lock in, like a key and a lock. And that’s the way our technology works in a nutshell.

Endpoint PCR is completely different. It drives higher levels of accuracy and specificity while reducing the turnaround time compared to qPCR – down to six hours from sample to result. In qPCR, you must enrich the sample for 24 to 48 hours, depending on bacteria or fungus, and then amplification and PCR analysis can be done in one to three hours. The accuracies and the turnaround times are the major differences between the endpoint PCR and qPCR.

Green: If I understand correctly, it’s a printed microarray in the well plate?

Patel: That’s correct. It’s a 96-well plate, and in each well, you’ve now printed all the probes for all targets in a single well. So, you’re not running more than one well per target, or per organism like you are for qPCR. You’re running just one well for all organisms. With our well plates, you’re consuming fewer wells and our patented foil-cover, you only use the wells you need. The unused wells in the well plate can be used in future tests, saving on costs and labor.

Green: Do you have any other differentiating IP?

The PathogenDx Microarray

Patel: The multiplex is the core IP. The way we process the raw sample, whether it’s flower or non-flower, without the need for enrichment is another part of the core IP. We do triplicate probes in each well for E. Coli, triplicate probes for Salmonella, etc., so there are three probes per targeted organism in each of the wells. We’re triple checking that you’re definitively identifying that bug at the end of the day. This is the cornerstone of our technology.

We were just approved by the State of New York, and the New York Department of Health has 13 different organisms for testing on cannabis. Think about it: one of the most rigorous testing requirements at a state level – maybe even at a federal level – and we just got approved for that. If you had to do 13 organisms separately, whether it’s plate culture or qPCR, it would become super expensive and very difficult. It would break the very backs of every testing lab to do that. That’s where the multiplexing becomes tremendously valuable because what you’re doing is leveraging the ability to do everything as a single test and single reaction.

Green: You mentioned New York. What other geographies are you active in?

Patel: We’re active in 26 different states including the major cannabis players: Florida, Nevada, California, Arizona, Michigan, New York, Oklahoma, Colorado and Washington – and we’re also in Canada. We’re currently working to enter other markets, but it all comes down to navigating the regulatory process and getting approval.

We’re not active currently in other international markets yet. We’re currently going through the AOAC approval process for our technology and I’m happy to say that we’re close to getting that in the next couple of months. Beyond that, I think we’ll scale more internationally.

I am delighted to say that we also got FDA EUA federal level authorization of our technology which drives significant credibility and confidence for the use of the technology. About a year ago, we made a conscious choice to make this technology federally acceptable by going into the COVID testing market. We got the FDA EUA back on April 20, ironically. That vote of confidence by the FDA means that our technology is capable of human testing. That has helped to create some runway in terms of getting federalized with both the FDA and the USDA, and certification by AOAC for our different tests.

Green: Was that COVID-19 EUA for clinical diagnostics or surveillance?

Patel: It was for clinical diagnostics, so it’s an actual human diagnostic test.

Green: Last couple of questions here. Once you find something as a cannabis operator, whether its bacteria or fungus, what can you do?

Patel: There are many services that are tied into our ecosystem. For example, we work with Willow Industries, who does remediation.

There’s been a lot of criticism around DNA based technology. It doesn’t matter if it’s qPCR or endpoint PCR. They say, “well, you’re also including dead organisms, dead DNA.” We do have a component of separating live versus dead DNA with a biomechanical process, using an enzyme that we’ve created, and it’s available commercially. Labs can test for whether a pathogen is living or dead and, in many cases, when they find it, they can partner with remediation companies to help address the issue at the grower level.

Another product we offer is an EnviroX test, which is an environmental test of air and surfaces. These have 50 pathogens in a single well. Think about this: these are all the bad actors that typically grow where soil is – the human pathogens, plant pathogens, powdery mildew, Botrytis, Fusarium – these are very problematic for the thousands of growers out there. The idea is to help them with screening technology before samples are pulled off the canopy and go to a regulated lab. We can help the growers isolate where that contamination is in that facility, then the remediation companies can come in, and help them save their crop and avoid economic losses.

Green: What are you most interested in learning about?

Patel: I would prefer that the cannabis industry not go through the same mistakes other industries have gone through. Cannabis started as a cottage industry. It’s obviously doubled every year, and as it gets scaled, the big corporations come in. Sophistication, standards, maturity all help in legitimacy of a business and image of an industry. At the end of the day, we have an opportunity to learn from other industries to really leapfrog and not have to go through the same mistakes. That’s one of the things that’s important to me. I’m very passionate about it.

One thing that I’ll leave you with is this: we’re dealing with more bugs in cannabis than the food industry. The food industry is only dealing with two to four bugs and look at the number of recalls they are navigating – and this is a multi-billion-dollar industry. Cannabis is still a fraction of that and we’re dealing with more bugs. We want to look ahead and avoid these recalls. How do you avoid some of the challenges around antimicrobial resistance and antibiotic resistance? We don’t want to be going down that road if we can avoid it and that’s sort of a personal mission for myself and the company.

Cannabis itself is so powerful, both medicinally as well as recreationally, and it can be beneficial for both consumers and industry image if we do the right things, and avoid future disasters, like the vaping crisis we went through 18 months ago because of bad GMPs. We must learn from those industries. We’re trying to make it better for the right reasons and that’s what’s important to me.

Green: Okay, great. That concludes the interview. Thank you, Milan.

Patel: Thank you for allowing me to share my thoughts and your time, Aaron.

PlantTag

Quality Systems 101: CAPA Programs Drive Improvement & Prevent Costly Mistakes

By David Vaillencourt
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PlantTag

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.

labsphoto
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.

Infrastructure & environmental controls/monitoring

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?

Growing the Seed of Sale: Integrating Security with Business Opportunity

By Ryan Schonfeld
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Anyone in the cannabis industry is well aware that theft of crops can economically devastate a grower. Security is critical, and thankfully, growers and dispensaries have many tools available to protect their investment. There is simply no excuse for not having a solid security posture to keep your business in compliance, from public-private partnerships to advanced security tools – in fact, it’s required in most jurisdictions.

In 2020, nationwide cannabis sales increased 67%, and support for legal marijuana reached an all-time high of 68%. New Frontier Data found that U.S. legal cannabis market is projected to double to $41.5 billion by 2025.

The industry’s advancement impacts numerous areas such as job and tax revenue creation and providing a wide variety of valuable opportunities. For cannabis facilities to keep up with the market expansion and experience success, they must face two significant challenges: achieving adequate security and efficient business operations. Though both can be seen as separate concerns, growers and producers must merge processes and solutions to tackle the issue as a whole.

Dispensaries are prime targets for burglary. Defending your storefront requires a comprehensive security plan

Along with rapid growth, dispensaries face traditional security risks, such as workplace violence and retail theft, while cybersecurity risks have also become more prevalent. These potential issues make it clear that the stakes are high, and as the potential impact on a business rises, the need for real-time, predictive response increases. Insider threats are another issue plaguing the industry when you look at the rate of theft, diversion and burglary that is attributable to employees.

The cannabis market is complex: it’s expanding rapidly, has to meet essential regulatory requirements and faces high-security risks. Therefore, security needs to be looked at holistically since it can be challenging to determine where a potential threat may originate.

With security top of mind, it is critical to move away from responsive behaviors and seek ways to manage security in a manner that gets ahead of threats, prevent them before they happen and respond to them in real-time. But does a grower or retailer have the time and expertise to manage all this while keeping an eye on how security affects the business?

Remote Security Operations

The ability to comply with government regulations and protect a valuable cannabis crop at all stages of its journey from seed to sale makes security systems a mission-critical asset for cannabis growers. Security operations centers create a safer and more productive environment and provide state-of-the-art tools to protect employees, retail locations and grow facilities. But some businesses in the cannabis market may not have the resources or space to have their centralized security operations, leading them to piece-meal security together or do the best with what they can afford at the time. Running these facilities can also be prohibitively expensive.

Security operations centers create a safer and more productive environment and provide state-of-the-art tools to protect employees, retail locations and grow facilities.

But new options take the process of security off the table. The business can focus on the growth of its core functions. Remote security operations services allow companies to take advantage of advanced security services typically only possible in larger enterprise environments. These services are offered on a subscription basis, delivered through the cloud, and are entirely customizable to detect risks unique to your business operations while saving each company significant expense.

Centralized security operations centers leverage intelligent tools, standard operating procedures and proven analytic methods to provide cannabis facilities with the information and guidance necessary to mitigate issues like retail or grow theft before they can have a significant impact.

The integrated, holistic response center staffed by experienced operators and security experts delivers a comprehensive security and regulatory compliance method. This approach is designed to provide complete data about what is happening across a cannabis business, from seed to sale, and how individual events can impact the company as a whole. As a result, stakeholders get the security intelligence they need, without the high overhead, personnel investments and complex daily management.

For those businesses in the cannabis market looking to supplement their security operations with other workforce but may not have the budget or infrastructure to do so, remote security operations services are something you should consider. With the experts handling all the heavy lifting, leaders can focus on growth. And, right now, in the cannabis industry, the sky is the limit in terms of opportunity.