AOAC International, an independent nonprofit standards development organization has announced the appointment of Dr. Katerina (Kate) Mastovska as their new deputy executive director and chief science officer.
Dr. Katerina Mastovska
Most recently, Dr. Mastovska served as chief science officer for the Eurofins US Food Division. She has been an active member of AOAC for almost twenty years, winning the Harvey W. Wiley Award in 2021, their highest scientific honor. “I’m delighted to join the AOAC staff and lead the team of dedicated scientists,” says Dr. Mastovska. “AOAC has a critical role in food safety, and I’m inspired to continue to be a part of this important work.”
AOAC International works actively in the cannabis industry through their Cannabis Analytical Science Program (CASP), a working group established in 2019 that is dedicated to developing standardized methods in cannabis testing. In the world of cannabis lab testing, AOAC International creates standards under the standard method performance requirements (SMPR®) moniker, which are detailed descriptions of what analytical methods should be able to do.
More recently, CASP launched their own proficiency testing program last year and launched their first round, shipping samples to labs across the country in the Fall.
Aeroponic & hydroponic systems grow plants at a highly accelerated rate. A “clean room” type of construction approach is the best way to manage this type of grow operation. Starting with a facility that is completely void of any kind of wood or materials that are porous is a good start. Cellulose materials collect moisture and encourage mold and mildew formation no matter how good the sealant.
We have seen cultivation spaces built out of dry wall over wooden post construction and studs that look sealed and solid on the outside of walls but when repaired for plumbing or other expansion work, they are black inside and covered with nasty mold that no one wants near their grow space.
Panel construction over steel frames or steel studs with skins is a safer, more sterile approach than retrofitting a wooden structure. Panel construction offers the added benefit of rapid assembly and minimal labor costs. We have seen 300 light rooms assembled in a few days so it is both very cost effective and safely sealed for protected growth.
Room Sizes & Count
How do you best fill this space if you have a clean slate?
If you have unlimited space, temperature and humidity management should determine the room sizes in your facility. Room sizes that are square in dimensions tend to be easier to maintain from an environmental standpoint. Long narrow rooms are good for fan airflow but tend to be more expensive from a cooling and dehumidification point of view. The larger the room, the more likely that you will get “microclimates” within the room which can challenge yield optimization.
Now, of course, many grows are retrofits of existing structures so compromises can be necessary. We have found that cultivators that have both very large and mid-size rooms in the same facility (200 lights versus 70 lights) are consistently more successful in the 70 light rooms. These “smaller rooms (~1,500 ft2) out-yielded and out-performed the larger rooms using the same genetics and grow plans. Compartmentalization also minimizes the risk in the case that a calamity (i.e. pest infestation) strikes the room. In a large room scenario, the losses can damage your operation. For this reason, we recommend 70-100 light/tub rooms as a standard.
Rooms should also follow your nursery economics. Structuring your nursery to produce just enough clones/veg plants for your next flower room avoids wasted plant material and resources. Breaking a larger space down into individual rooms means that you need fewer veg plants to fill your flower room that week. The best way to optimize this is to have a number of rooms that are symmetrical with the number 8 (typical 8-week cycle genetics).
With 8 rooms running flower, you are able to plant one room per week for 8 weeks. In the 9th week, you start over on room 1. This continuous harvest process is highly efficient from a labor standpoint and it minimizes the size of your mothers room (cost center). Additional space can be applied to your flower rooms. If you do not have infinite space, even divisors work just as well; 2 or 4 rooms can be planted in sequence for the same optimization (for 2-room structures, harvest and replant 1 room every 4 weeks for example). The optimal structure (8, 16, 24, or more rooms) enables you to optimize your profitability. If any of this needs further explanation, please just ask.
Not photoshopped: An “ideal” 70-tub flower room in a CEA greenhouse (courtesy of FarmaGrowers, South Africa)
Within your room choice, movable rows or columns of tubs/lights also provides optimal yields. Tubs/plants can be moved together for light usage efficiency and one 3-foot aisle can be opened for plant maintenance. Racking systems or movable trays/tubs make this convenient nowadays.
Floors
Concrete floors offer pockets for bacteria to collect and smolder. As such, they have to be sealed. Proper application of your sealant choice is required so that it does not peal up or crack after sealing. There are many benefits to sealed floors that is discussed in the white paper. Floor drains are the equivalent of a portal to Hell for a sterile grow operation. Avoid them at all costs.
Phased Construction
Tuning or optimizing you grow rooms for ideal flowering operation depends on your location. Our advice is that you build and optimize your facility in phases with the expectation that nothing is perfect and you will learn improvements in every phase of expansion. The immediate benefit is production that you can promote to your sales channels and revenue that starts as soon as possible to improve your profitability. This is also an excellent learning curve to apply to subsequent rooms. Our happiest customers are those that learned construction improvements in early rooms that were able to be applied to following rooms without headache. The ability to focus on one or two rooms also allows you to get the recipe correct rather than just relying on “winging it”.
Don’t Be In A Rush To Go Green
A 70-tub flower room (courtesy of FarmaGrowers, South Africa)
Validate your water supplies and their stability. Verify that the water in your aeroponic or hydroponic feeds that get to your plants are clean and sterile. This is much easier in a step-by-step fashion than in a crisis debug mode once production is in progress. Be very cautious about incoming clone supplies. We will talk about this more in the next chapter on Integrated Pest Management but incoming clones are a top pest vector that can contaminate your entire facility.
Warehouse Versus Greenhouse Cultivation Spaces
As we started out, controlling your environment is your most important concern. We have seen success in both indoor rooms and greenhouses. The defining success factor is controlling humidity and temperature. Modern sealed controlled environment (CEA) greenhouses do this well and CEA is somewhat of a given for indoor grows. More details on this in the white paper.
Packaging these recommendations gets you to the perfect body for your Formula 1 race car. Now, you are ready to look at some of the mechanics of protecting your operation from pesky little critters and biologicals that can derail your operation and weaken your engine.
Before we sign off this week, I wanted to highlight the ultimate build-out that we have seen so far. Of course, there are many challengers that have done this well but at this point, FarmaGrowers in South Africa has the best thought out facility we have seen. They acquired Good Manufacturing Practice (GMP) & Good Agricultural & Collection Practice (GACP) certification early in their operations due to very well-thought-out designs. They are exporting to global markets without irradiation today. Certainly, many successful customers have beautifully thought-out operations and there are several upcoming facilities that offer amazing planning that will challenge for this crown, but for now. FarmaGrowers leads the pack in this aspect. See here for a walkthrough.
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 Facilitywhite 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.
Cannabis testing laboratories are one of the major players in the industry for protecting public health. Ensuring that laboratory test results are reliable and valid requires a multipronged approach involving method validation, proficiency testing and performing frequent reviews of equipment and processes.
Cannabis testing laboratories often use a variety of different methods to conduct proficiency testing. Laboratories can either participate in programs run by ISO/IEC 17043-accedited proficiency testing providers or through intralaboratory comparison. Comparing different instruments, methods, technologies against pre-defined criteria is a must when validating methods for a specific type of test and ensuring the competence of the laboratory.
Beyond proficiency testing, there are a number of other stopgaps at a laboratory’s disposal for ensuring valid results, like using accredited certified reference materials, performing checks on measuring equipment frequently, reviewing reported results and retesting retained items. All of that and more is outlined in the ISO/IEC 17025:2017 standard, section 7.7.
What good is a test result if you cannot attest to its validity?
There’s a lot that goes into making sure laboratories provide valid results, much of which is detailed in the accreditation process. For more information, we sit down with Keith Klemm, senior accreditation manager for ANSI National Accreditation Board to learn about laboratory accreditation, method validation and other certifications and credentialing available in the cannabis industry.
Q: Why is method validation important for cannabis test methods?
Keith Klemm: Because cannabis production, testing, and sales is regulated by each individual state, there are very few standard methods for testing cannabis and cannabis-derived products. Non-standard methods or methods developed by the laboratory must be validated to ensure the methods are fit for their intended purpose. What good is a test result if you cannot attest to its validity? There would be no confidence that the results are accurate. Additionally, while organizations such as ISO, AOAC and ASTM are developing standard methods for use in the laboratory, the wide range of products and matrices being tested require modifications to standard methods. Standard methods used outside their intended scope must also be validated, again to ensure the method remains fit for the intended purpose.
Q: We’re pretty familiar with laboratory accreditation. What other accreditations are available in the cannabis industry?
Klemm: Accreditation programs are available for product certification and personnel credentialing, in addition to laboratory accreditation. ANAB’s product certification program was launched in 2020 and is based on the requirements of ISO/IEC 17065. The program combines the requirements of this standard with specific scheme requirements to attest to the competency of certification bodies who then certify products within the scheme. Two schemes are in development specific to the cannabis industry: Cannabis Safety and Quality (CSQ) and PurityIQ. For personnel credentialing, a new Cannabis Certificate Accreditation Program (C-CAP) was developed and is based on ASTM D8403, Standard Practice for Certificate Programs within the Cannabis and Hemp Industries. It also includes any additional state Responsible Vendor Training requirements.
Q: What are the steps to becoming an accredited cannabis testing laboratory, product certification body, or C-CAP organization?
Klemm: The process begins with a request for quote. The organization prepares for the initial assessment by implementing the requirements of the applicable standards, regulatory requirements, and scheme requirements. ANAB believes in a partnership approach to accreditation with a focus on customer needs while ensuring accreditation requirements are met. Once the organization is ready, an initial document review is performed. The accreditation assessment is then performed on-site by technically skilled and knowledgeable assessors. If any nonconformities are encountered, the organization provides a response with cause and corrective actions. Once all nonconformities are resolved and technical review is completed, a scope of accreditation and certificate are provided to the organization. The technical review may vary depending on the accreditation that is being sought, but the general process of accreditation is the same. After accreditation is achieved, the organization moves into a cycle of surveillance and reassessment as defined by the accreditation program and any scheme requirements.
About Keith Klemm
Keith Klemm is a graduate of Manchester University with a B.S. in Biology. Keith is an experience laboratory director and operations manager with 30 years’ experience in the laboratory environment and has worked as a senior accreditation manager for ANSI National Accreditation Board for the past five years.
Keith’s areas of expertise include:
Microbiological assays for food, medical device, and environmental test matrixes.
Environmental chemistry of water and wastewater.
Biocompatibility testing of medical devices.
ISO/IEC 17025:2017
AOAC International – guidelines for food laboratories program requirements
21 CFR Part 58, GLP program requirements
EPA NLLAP program requirements
AAFCO program requirements
FDA ASCA Pilot program for Biocompatibility
Michigan Cannabis Regulatory Agency program requirements
When people have to make important decisions, we often consult a third party to increase our knowledge and confidence in a product. For instance, when choosing a car, an individual may weigh heavily on safety ratings and other awards from organizations such as Consumer Reports. These awards are often boasted and a heavy focus in car commercials because it tells the consumer that a third party has deemed their car valuable to own. For more than 100 years, the Association of Official Agricultural Chemists (AOAC® International) has operated in this exact manner, and has set the bar and guidelines for testing in the cannabis industry through its special program called the Cannabis Analytical Science Program, also known as CASP.
The CASP program is designed to develop standards and validation guidance to evaluate testing methods, as well as the methods’ ability to detect the target organism or compound on the cannabis matrix. With the addition of new states permitting the legal sale of both medical and adult use cannabis and no federal governing body overseeing testing regulations, the value of AOAC cannot be understated, as these guidelines allow cannabis testing laboratories to have their own third-party reference to look to when choosing a compliant testing method to implement in their laboratory.
AOAC was founded in 1884 by the US government as the standard setting body in the country and, in 1991, became an independent association known as AOAC International, with a goal of building a reputation as an international, consensus-based standard-setting body and a conformity assessment organization in analytical sciences. As an independent third-party resource, AOAC has the Performance Tested Methods’ (PTM) and Official Methods of AnalysisSM (OMA) programs for certification of analytical testing methods in both biology and chemistry.
If analytical methods, including proprietary test kits, are deemed acceptable, AOAC provides approved certification, their seal of approval that the method works as designed. Though multiple factors are considered to determine if AOAC approval is given; accuracy and precision of the method are among the most important. For example, when validating a cannabis method for microbiology, AOAC will contract an independent testing facility to conduct a series of tests with known spiked samples to measure the recovery limit of the target microorganism. This allows the organization to determine if the method is sensitive enough to be named an AOAC-approved method through either the PTM or OMA conformity programs. Another way of ensuring the validity of results is by conducting an inclusivity and exclusivity study on a method. In this type of experiment, target organisms are tested while also spiking with non-target organisms to see if there will be a high rate of false positives.
In cannabis, discussions have grown surrounding testing of four strains of Aspergillus, which are A. terreus, A. flavus, A. fumigatus and A. niger. By spiking cannabis with one of the four Aspergillus strains and on a separate sample with a non-target Aspergillus strain such as A. clavatus, it ensures that only the target strains are being recognized and recorded on the method being tested.
This methodology limits the likelihood of unconfirmed positives occurring, ensuring the validity of the results. Of course, when a method is undergoing an actual AOAC evaluation for approval, the testing requirements for both the sensitivity and inclusivity/exclusivity experiments are much more thorough than the explanation above.
Regardless of which AOAC-approved method you select, you can feel confident that most of the “heavy-lifting” is done and that the method is accurate and precise enough to implement in a cannabis testing facility. In turn, the cannabis testing laboratory then only needs to complete their own internal method verification to ensure the method works with their processes, people, environment and product, but on a much smaller scale and aligns with state regulations.
On a consumer safety level, AOAC-approved methods are designed to keep cannabis consumers safe. Whether they are an adult using cannabis or medicinal cannabis patient, the product that is being sold should be held to the highest safety standards. By having a laboratory that is utilizing an independently approved AOAC method, an additional layer of confidence is achieved that the product being consumed is safe. This ultimately limits the number of costly recalls from dispensaries and minimizes risk to consumers. At the end of the day, cannabis testing laboratories want to keep the public safe and it is our job to do so. This means implementing these independently approved methods from agencies such as AOAC at various touch points in the seed to sale cycle to ensure the data is validated and reliable.
Overall, just as it is equally important to get a non-biased and reputable third-party approach to your automobile search, a scientist that is responsible for choosing methods in their cannabis compliance laboratory should also consider these third-party approvals. As a scientist, the goal every day is to report accurate data to help the client and the consumer equally. The cannabis compliance laboratories are the last line of defense in preventing harmful or contaminated products from getting into the marketplace and any extra assurance we have with our testing methodology is always encouraged. Ultimately, AOAC’s work is important and their standard of quality and safety is a must-have in the cannabis laboratory.
bioMérieux, a leader in the in vitro diagnostics space and a supporter of the cannabis testing market, announced last month that they have achieved the first ever AOAC International approval for PCR Multiplex Detection of STEC and Salmonella in cannabis flower for their GENE-UP® PRO STEC/Salmonella Assay. The performance tested method approval for their new assay accomodates simultaneous enrichment and detection of STEC (Shiga Toxigenic Escherichia coli) and Salmonella spp. in cannabis samples.
The method is aimed at increasing efficiency in cannabis testing labs by reducing sample preparation time for microbiological testing. With the single enrichment and real-time multiplex PCR detection, bioMérieux says their new assay can provide reliable detection of STEC and Salmonella in 24 hours using just a single test.
PCR technology is one of the most widely utilized testing methods for detecting pathogens in a variety of matrices. bioMérieux claims it is easy to use, scientifically robust and reduces costs, time spent testing and errors.
Maria McIntyre, cannabis strategic operations business manager at bioMérieux, says that AOAC performance tested method approval is setting the bar for cannabis testing laboratories and furthering cannabis science. “AOAC International impacts cannabis science by setting analytical method standards that act as the benchmark for method validation,” says McIntyre. “This simplifies the validations needed by cannabis laboratories and assures the utmost confidence in product safety and human health.”
Lean management or Lean thinking is a process for continuous improvement that can be applied to any business. Most frequently Lean is attributed to the manufacturing sector due to its origins in Japan at the Toyota Motor Company. Lean originated in post-war Japan where resources were scarce as the country rebuilt itself after World War II. The scarcity of resources forced the Japanese to do more with less which manifested itself within the Toyota organization as the Toyota Production System from which Lean originated.
Today, Lean thinking is being applied to every industry and we believe that the cannabis industry, and in particular laboratories, can benefit tremendously from its principals.
What Is Lean and How Does it Apply to Cannabis?
Lean thinking is a set of powerful tools for any business or organization that wants to be the best in their industry and deliver superior value their customers. This is especially relevant to the fast-growing cannabis and hemp testing industry where customers demand fast turnaround times and error-free results.
The reason that Lean applies to all businesses and especially the cannabis industry is because of its focus is on eliminating waste. Waste comes in many forms including defects, waiting time, extra motion, excess inventory, transportation, over production, over processing and underutilized talent.
Companies that adopt Lean management eliminate waste using a wide variety of tools that help surface issues and eliminate the root causes. When companies eliminate waste, they simultaneously improve both their speed and quality, two attributes that customers really care about. Given the fast-changing nature of the cannabis industry and differences state by state, we believe that using Lean thinking to eliminate waste is critical to being a top performing business in the cannabis industry.
One important tool that many businesses begin with is known as 5S or 6S. At our laboratory we recently implemented 6S to organize both our office and laboratory spaces. 6S is a process improvement tool that stands for Sort, Set in Order, Shine, Standardize, Sustain and Safety. The process involves each technician or analyst assessing their areas and asking critical questions such as: Can I easily reach everything I need for this test or process? Is there wasted motion due to the placement of items within the lab? Can I easily tell how much consumable inventory I have on hand at a glance?
This process also helps improve safety because the workspace is better organized, easier to navigate and designed with safety in mind. Each person is responsible for maintaining their workspace and regular audits by rotating teammates, helping drive continuous improvement to our 6S. It is a fundamental process for any business starting to adopt Lean thinking.
Another very helpful process that any cannabis business can implement is the Gemba walk. Gemba is the Japanese word for “actual place” and refers to the place in a business where value is created for the customer. Value in our cannabis business is created in our testing lab. By improving everything in our testing lab we improve our quality and speed for our customers. In our laboratory we begin the Gemba walk as a team reviewing our key performance indicators (KPIs). From there, the management team visits each station to review additional KPIs and discuss any issues that group may be having. We try to surface issues, however small they may be, so that they are solved and hopefully eliminated. This process is key to helping us keep a pulse on the lab, engaging employees and better understand the improvements that need to be made.
How to Implement Lean Processes
Without quality results, a testing laboratory does not really have a product or service to offer
Lean thinking is a very accessible set of tools. Unfortunately, it is quite difficult to implement because of the dedication that it requires. Implementing Lean and changing the culture requires a significant amount of time, investment in training and management commitment. Time and capital for training can be scarce at some businesses in the cannabis industry. For the businesses with capital, it is extremely important that management commit to implementing Lean and changing their culture. Without the support of the executive team most businesses stop implementing new procedures and revert to how they are used to operating. It is also common for changes in management to result in lean becoming deprioritized in place of a new initiative.
If the executive team is inexperienced in Lean management, it will be important to find a Lean consultant that can guide the training and events. A Lean consultant should be able to provide you with thorough training on each tool and help your business implement them in real time to improve the business. The training and knowledge gained during these events are extremely valuable and practical tools that every employee can use.
Results From Implementing a Lean Organization
If a business is able to successfully implement Lean management the results for their customers can be dramatic. In the laboratory setting, turnaround times will be reduced, and more importantly, will remain consistent despite fluctuations in sample volume. Faster turnaround times for cannabis companies means that they can bring inventory to market faster which can be critical for supply constrained businesses.
Additionally, implementing Lean helps reduce the number of errors, rework and retests so the quality of the results for the customer is dramatically improved. Root cause issues are solved, processes are updated and then shared with the entire team so that everyone can learn and benefit from the improvement. Without quality results, a testing laboratory does not really have a product or service to offer so it is critical to get it right every time.
All areas of the cannabis industry are becoming more competitive, and it is important for every business to make sure they can stay competitive considering changing market dynamics. Lean management has helped businesses in other industries stand apart from the rest and we believe that the cannabis industry will be no different. Academic literature has studied and documented the positive impact that Lean has on businesses globally. Lean management has repeatedly shown that businesses that can truly implement Lean thinking in everything that they do will have an inherent advantage because they’ll be faster, more agile, higher quality, more efficient and focused entirely on creating value for their customer.
Earlier this year, the Colorado Department of Public Health and Environment (CDPHE) announced a plan to introduce new testing rules for the state’s growing hemp industry. Under the new regulations, hemp products must be tested for residual solvents, heavy metals and pesticides, in addition to making sure they contain less than 0.3% THC.
The CDPHE are planning on a gradual rollout to prevent any supply chain issues or a lab testing bottleneck, similar to what we’ve seen in other states launching new testing requirements in years past, such as Arizona or California. Well, the Colorado rollout appears to be hitting similar snags and because of supply chain issues related to instruments and consumables in laboratories, the implementation of those testing rules is somewhat delayed. What was originally supposed to be implemented over the summer was pushed back to an October 1 deadline, and that deadline has now been pushed back to 2022.
The pesticide testing list to be implemented January 1, 2022
As a result of supply chain shortages and the learning curve to test for such a wide range of pesticides, Colorado is opening hemp testing to out-of-state labs in an effort to stay on schedule with the rollout. Dillon Burns, lab manager at InfiniteCAL, a cannabis testing company with locations in California and Michigan, just completed an audit with the CDPHE in their work to get certified and start conducting hemp testing for businesses in Colorado.
Burns says they’re well-acquainted with the list of pesticides because of how similar the list is to California’s requirements. “For the pesticide testing rules that were supposed to go into effect on August 1st, it’s basically the same list as California just with slightly different action levels,” says Burns. “I would say these action limits are generally stricter – they have much lower LOQs [limits of quantification].”
The pesticide testing list (continued) to be implemented January 1, 2022
Come January 1, 2022, they are expecting an additional 40 pesticides to be required under the new rules. “But currently, it’s still unclear when these regulations will actually go into effect,” says Burns. The full pesticide testing list is currently slated to be implemented on April 1, 2022.
The supply chain issues referenced above have a lot to do with what the state is asking labs to test for. Previously, most of the pesticides tested for under Colorado’s adult use and medical cannabis programs could be analyzed with an LC/MS. A handful of pesticides on the new list do require GC/MS, says Burns. It’s entirely possible that a lot of labs in Colorado just don’t have a GC/MS or are in the process of training staff and developing methods for using the new instrument. “Cleanliness of these instruments is such a priority that it takes time to acquire the right skill set for it,” says Burns.
Dillon Burns, Lab Manager at InfiniteCAL
The new testing rollout isn’t just another compliance hurdle for the cannabis industry; these rules are about protecting public health. Dillon Burns said he’s seen hiccups in California with the amount of new hemp farmers getting into the space. “The hemp products we’ve tested in California often fail for pesticides,” says Burns. It’s a lot easier in most states to get a license for growing hemp than it would be for growing adult use cannabis. “You’ll see a lot more novice growers getting into hemp farming without a background in it. They’ll fail for things they just haven’t considered, like environmental drift. We see a lot of fails in CA. Hemp is bioaccumulating so it presents a lot of problems. If they’re not required to look for it, they weren’t monitoring it.”
When asked how the market might react to the new rules, Burns was confident that Colorado knows what they’re doing. “I don’t anticipate that [a testing bottleneck] happening here. The regulators are reasonable, supportive of the industry and opening it up to out-of-state labs should help in preventing that.”
The NIST is an organization under the U.S. Department of Commerce that promotes innovation through standards, technology and advancing science. The NIST’s CannaQAP platform works with cannabis labs to help improve competence in analytical science and standardization.
The program requires participating labs to conduct exercises that help inform the NIST about current industry standards and capabilities for hemp and cannabis testing. One of the goals of the program is aiding in the design and characterization of cannabis reference materials.
Kaycha Labs took part in two exercises for the CannaQAP study. Exercise 1 included testing for potency with 17 cannabinoids in hemp oil and Exercise 2 included potency, heavy metals and moisture content testing in plant materials.
Chris Martinez, president of Kaycha Labs, says the program can benefit the entire industry when it comes to regulatory compliance testing. “As a leading cannabis lab company with a network of labs in multiple states, it is imperative we demonstrate that our labs apply compliant and consistent testing methodologies,” says Martinez. “Assuring all industry participants, including State and Federal government regulators, that precise and consistent testing data is the norm will benefit the entire industry.”
Kaycha Labs, while based in Fort Lauderdale, actually has cannabis testing labs in California, Colorado, Florida, Massachusetts, Nevada, Oklahoma, Oregon and Tennessee, making them an ideal candidate for CannaQAP.
Exercise 1 has been completed in its entirety and published here. Exercise 2 has completed the participation and data submission legs of the study and NIST is preparing it for publication. On their website, it says that announcements about their upcoming Exercise 3 are coming soon.
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
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