Fingerprints of a Killer: Why Medicinal Cannabis Needs a Cleanroom Engineered Solution

Fingerprints of a Killer: Why Medicinal Cannabis Needs a Cleanroom Engineered Solution

This article outlines the use of ultra clean spaces for the processing and manufacturing of medical cannabis products. We'll explore the effect of cleanroom environments on temperature, quality, and humidity for cleaner, safer, and more energy efficient medical cannabis production and processing.

Large scale cultivation of medical marijuana presents a number of challenges for potency and consistency. Differing cannabis strains, vegetative cycles, and cannabis production areas all require unique controls. The rigours of medicinal product approval and testing is driving facilities out of dirty warehouses and into pharmaceutical grade environments.

Pesticide reduction and minimizing contaminants like mold, mites, and microbes is essential for the progression of cannabis derived medicine. Before we address the downsides and challenges of indoor grow rooms, we’ll first mention some of its historic advantages.

The Advantages of Indoor Medical Cannabis Grows

For photosynthetic processes controlling the intensity of light, temperature, and C02 is a cornerstone of translating gas and water vapor exchange into growth. Soilless indoor cannabis farming offers many benefits over traditional, outdoor farms: higher crop densities and yields, many more harvests per year, complete control over all growing parameters and variables, and eliminating pest and disease vectors.

Due to the allogamous (cross-fertilization) nature of the species, maintaining chemical profiles of THC product genotypes is difficult under outdoor field conditions. Indoor medical marijuana grows limit deviation, cross pollination, improve security, regulatory control, and improve the quality and consistency of yields. In parallel, changes in global and seasonal weather patterns do not threaten the viability of climate dependent medicines.

Challenges for Uncontrolled Indoor Cannabis Grows

Indoor grows face distinct challenges that outdoor grows do not. A tropical combination of heat, humidity, and moisture accelerate cannabis production, but also incubate bacteria, insects, and fungal families. The largest liability for cannabis producers is safety, and the monetary risks of large scale product contamination. Likewise, dosage accuracy and potency remains a challenge that the medical cannabis industry struggles to reach. 

Cannabinoid Dose and Label Accuracy in Edible Medical Cannabis Products 

Quality, potency, and labeling for medical marijuana products sold in retail stores have faced scrutiny and setbacks.

2015 study by researchers at John Hopkins University found medical marijuana products rarely contained the exact amount of ingredient stated on the label.

75 products were purchased (47 different brands), and tested for comparison of actually THC content to the ingredient and potency labels.

  • 17% were accurately labeled
  • 23% contained higher THC than labeled
  • 60% contained lower THC content than labeled 

“Greater than 50% of products evaluated had significantly less cannabinoid content than labeled, with some products containing negligible amounts of THC. Such products may not produce the desired medical benefit.”

Fingerprints of a Killer: Deaths and Illness Linked to Contaminated Cannabis 

A 2017 USC Davis study discovered multiple bacterial and fungal pathogens within California medical marijuana products.

The study was conducted after doctors identified a relatively rare but lethal fungal infection in two cancer patients who later died. They were relatively young, in winnable cancer battles.

In a subsequent study, the team gathered 20 samples of medical marijuana from across California and analyzed the samples for dangerous bacteria and fungi with DNA analysis.

“The cannabis was contaminated with many bacteria and fungi, some of which was compatible with the infections that I saw in my patients — Klebsiella, E.coli, Pseudomonas, Acinetobacter, these are all very serious infections for anybody in the hospital. But particularly in that population, the cancer population”.

“We were a little bit startled that ninety percent of those samples had something on them. These weren’t just any pathogens, [we] were looking at the very fingerprints of a killer.“

The connection of fungal infection to moldy marijuana isn’t a recently discovered phenomena. A 1981 study by the Milwaukee County General Hospital  found evidence of fungus in the blood of 11 out of 12 marijuana smokers.

“The researcher also found antibodies produced by the body to combat the fungus in the blood stream of more than half of his subjects.”

Risks of Fungal Infection when Vaporizing or Smoking Tobacco and Marijuana

The threat of fungal infection is historically deadly, especially when introduced directly into respiratory or nervous systems.

Studies have shown that tobacco and marijuana harvests may yield significant amounts of fungal spores and plant pathogens such as Aspergillus. Aspergillus is associated with serious diseases in humans and animals.

Acute invasive aspergillosis is a from that grows into body tissue, and is most common in those with weakened immune systems such as chemotherapy or AIDS patients. It is also known as a cause for neonatal infections.

  1. Invasive aspergillosis has been described in association with marijuana smoking in two cancer patients on chemotherapy, two leukaemia patients, a renal transplant recipient, and a few patients with AIDS.
  2. There have been two reported cases of ABPA associated with moldy marijuana. Given the frequency of asthma and ABPA, and the high frequency of marijuana usage amongst young people, these cases may represent a tiny proportion of those affected.
 

For medical marijuana patients, direct exposure to vaporized cannabis products fuels complications and may accelerate, or even cause respiratory related ailments. 

Once considered a weak pathogen, modern immunosuppressive therapies increase the likeliness of deadly infections amongst Aspergillus exposure. A study conducted between 2008 – 2011 of patients with invasive aspergillus (IA) highlights a compelling mortality rate when a patient also sufferers from an underlying disease or immunodeficiency. Of the 152 patients studied, IA infection played a role in 62 patient deaths (67.4%). In 36 cases, IA is a direct cause of death. Fifteen of those cases were diagnosed post-mortem. The study indicates that IA infections are not only difficult to treat, but also difficult to detect. A preventative solution is essential.

Impact of Airborne Fungal Spores and Toxins on Medical Cannabis Workers

Airborne fungal spores and toxins are also a concern for medical cannabis workers and processors. These CDC findings stir concern for the long-term health of cannabis cultivation workers exposed to fungal and bacterial strains known to cause harm against humans.

"Microbiological exposures including endotoxin, bacterial, and fungal species may place workers at risk of allergic sensitization and respiratory issues. For example, B. cinerea has previously been linked to a hypersensitivity pneumonitis condition commonly known as wine grower’s lung. Exposure to Actinobacteria and fungus like B. cinerea can increase the risk of allergic and respiratory symptoms."
Airborne Health Hazard Evaluation Report

Another study from the organization National Jewish Health ads that molds also generate hazards specifically for indoor grow workers.

Eliminating harmful pesticides and mitigating mold and fungus is a crucial barrier for the success of medicinal cannabis products. Adoption of cleanroom technology proves historically advantageous in processing and production within biomedical, electronics, and pharmaceutical fields.

How Cannabis Cleanrooms Mitigate Fungal, Mite, and Microbe Infections

cannabis grow room

Pharmaceutical, biotech, and food industries all rely on stringent procedural and environmental controls. It’s only a matter of time before medical cannabis products face the same regulations. 

Cleanroom technology is adopted for a number of reasons: 

A) To protect workers from hazardous chemicals 

B) To protect sterile products from contamination 

C) To protect sensitive products from particulate within room air or as byproducts of human inputs, such as aerosols, skin cells and hair. 

The result is environmental control with a threshold of a few particles/sq. ft.

Aerospace, electronics, and biosciences use cleanrooms to improve final quality, batch control, and enhance regulatory compliance. Medical cannabis as federally regulated medicine also requires traceability and accountability.

Canadian Medical Marijuana Regulation and Testing

In Canada, medical marijuana grows have staunch regulation, testing, and inspection. Federal inspectors tour facilities monthly (2) to ensure that cannabis grows meet national standards. Contamination is core of concern. Sample testing is carried out by federally regulated laboratories, therefore the standard of expectations and results are more uniform.

Emblem Cannabis is one Canada’s largest medical marijuana cultivators.

“In order to grow a product capable of passing microbial tests, Emblem protects each grow room with positive air pressure. While typical hinged doors allow foreign particles to enter each time they’re opened, Emblem’s high-pressure rooms prevent contaminants from entering. Employees working inside the grow rooms cover themselves from head to toe in cleanroom suits to prevent anything on their clothing from contaminating the sealed environment. There’s not a lot of possibility for contamination between the grow rooms and in the processing areas; they are both separate, and a high degree of sanitation is required.”

Agricultural, supplement and pharmaceutical manufacturers face stringent regulation and accountability for the safety of patients and consumers. As state laws expand over medical marijuana manufacturing, testing, and labeling, cannabis cleanrooms offer medical marijuana growers a higher degree of certainty for meeting and exceeding regulatory standards.

US and State Regulations for Medical Marijuana Testing

In the USA, product testing is limited to state governed laboratories and protocols. Many states have adopted aggressive protocols for microbial testing.

In Connecticut, if a sample fails any microbial test based on the testing regulations set forth by the state, the producer must dispose of the entire batch without any sales or production.

In Colorado, new rules require testing for microbes (E. coli, salmonella and total yeast and mold) for flower, infused products and concentrates. Also, solvent-based medical marijuana concentrates must be tested for residual solvents.

California regulation includes microbiological impurity, including total aerobic microbial count, total yeast mold count, P. aeruginosa, aspergillus spp., s. aureus, aflatoxin B1, B2, G1, or G2, or ochratoxin A at levels that are lesser of either the most current version of the American Herbal Pharmacopoeia monograph or the State Department of Public Health. 

The full cost of a contaminated product from seed-to-sale is a fraction of the cost when discovered before distribution: once it reaches markets, recalling a product is catastrophic. History has shown that poor manufacturing controls and shortcuts lead to undetectable risk and crippling penalties: emissions falsification, exploding phones, contaminated peanut butter.

What is a Cleanroom and How Does it Improve Air Quality and Production?

Generally speaking a “Clean Room” is an enclosed room that has equipment which controls the amount of particulate matter in the air by using air pressure and filters. To meet requirements of a “Clean Room” as defined by Federal Standard 209E and newer ISO Standards, all cleanrooms must not exceed a particulate count as specified in the air cleanliness class.

ISO 14644-1 Cleanroom Standards

An ISO Class 3 cleanroom is considered the high level of cleanroom adopted for today’s technology. While higher levels of cleanliness are achievable, they are generally not required. Hypothetically cannabis cleanrooms could range from an ISO Class 5 as used in pharmaceutical cleanrooms, or upwards to an ISO Class 8 common for packaging and processing operations. Once the room is completed, most specifications call for testing and certification. Testing is usually conducted by an independent testing agency using the ISO Standards. It is also imperative for the owner to purchase a clean room monitor in order to determine the daily status of the room.

Controlling Temperature, Humidity, and Moisture for Medical Marijuana Grow Rooms

Bright, warm vegetation areas with plentiful water supplies harbor a number of unwanted bacteria and fungus.

Humidity levels that rise above 80% increase the risk of fungal, bacterial, and viral infections. Humidity levels that drop below 70% reduce photosynthetic efficiency and may affect yields. Much like a petri dish, bacteria or fungus incubates and may not be present immediately, but without environmental controls the product is likely to fail bacteriological screening.

Water sprayed leaves create warm, wet environments that foster microbes, mildews, yeast, and fungus growth. The effect is accelerated when an unfavorable level of water vapor pressure generates dew condensation. The single most effective way to stifle the growth of mold and mildew is by controlling moisture, humidity, and temperature proactively.

Ideal Moisture and Humidity for Medical Marijuana Grows

The Cannabis Business Times offers an in depth look at what cultivators must understand about the science of humidity to keep plants healthy and thriving.

Mark June-Wells, a laboratory director for Connecticut Pharmaceutical Solutions (CPS), is one of four licensed medical cannabis producers in the state. Dr. June-Wells holds a Ph.D. in botany/plant ecology from Rutgers University, and has engineered CPS’ cannabinoid extraction efficiency and tracking programs. He developed one of the largest production databases in the United States, and created efficient and repeatable production methods informed by rigorous data collection and statistical model building.

He states that a grow room should maintain a temperature between 75 ºF and 80ºF (18-26ºC) during light phases, and slightly cooler during dark phases (~70ºF.) Humidity levels vary within growing stages:

  • Cloning: 70%-75% RH
  • Vegetation: 65%-70% RH
  • Flower: 60%-65% RH
  • Night phase of flower: 55%-60% RH

How Cannabis Cleanrooms Improve Control of Moisture, Temperature, and Humidity for Medical Marijuana Grows

Because humidity and temperature maintain a direct relation, changes in temperature reflect in humidity levels and vice versa. Cleanrooms aid control of temperature and humidity swings by recirculating up to 80% of room air. Preconditioned air, once filtered and recirculated offers a higher degree of control and efficiency than once through systems that pull in 100% new air.

Preventing Powdery Mildew

Cleanrooms prevent powdery mildew (PM) with tight vapor pressure gradients, air flow and humidity control. Well engineered air flow systems with HEPA filtration avoid recirculating airborne pathogens and fungal spores. Laminar flows minimize the congregation of dirty air, smooth thermal gradients, and regulate humidity variation during air changes. The result is a stabilized pressure that moves air methodically through a canopy. Evaporation and temperature variation is more methodical, therefore pressure variance is less pronounced and more controlled. Oscillating fans spread contamination throughout a space, therefore sacrificing cleanliness. Laminar air flow is filtered and recirculated with precision, thus contamination is avoided before pesticide application is required.

How Optimizing Vapor Pressure Deficit Improves Cleanliness for Cannabis Cultivation

“By creating a vapor pressure deficit [VPD, the difference between the amount of moisture in the air and what the air can hold at that temperature] in the flowering bays of our 2-acre greenhouse with our … automated environmental control system, Strawberry Fields has been able to prevent the growth of powdery mildew and Botrytis on over 25,000 lbs. of cultivated marijuana and has passed roughly 200 microbial tests, making it safe for consumption and available for wholesale,” explains Samuel Thoman, chief of business development for Strawberry Fields in Colorado.”

Cleanroom Wall and Construction Features

Advancements in cleanroom wall panels unhinge control over not only exterior room dimensions and environments, but also over the properties of internal wall designs. Modular wall panels extend design freedom by offering customization of internal insulation for improved heat retention. The ability to integrate electrical conduits, product passthroughs, windows, ducting, air filters, and storage cabinets into structural design accelerates installation and overall performance. Space and workflow is optimized on application specific basis. The rooms have very high insulation value which improves cooling efficiency, and they are tightly sealed which improves humidity control and prevents cross contamination.

Benefit of Modular Cleanroom Designs for Tighter Environmental Control

The benefit of modular cannabis cleanrooms over traditional fixed wall grow rooms is that the configurable partitions of modular cleanroom designs lower the cost of installation or re-configuration for changing regulations. Divider rooms total environmental control, larger yields, and improve regulatory compliance at various stages of the growing cycle. Likewise, variable control and adjustment of humidity, temperature, and contaminants within each cell is a paramount advantage for consistency and potency over facilities with uninterrupted passage between each staging room of a cannabis grow.

Assessing the Current Landscape and Trajectory of Medical Marijuana Regulation

The Importance of Controlled Grows for Medical Marijuana Products: Garnishing Pharmaceutical Caliber Results 

The FDA’s (Food and Drug Administration) repackaged stance on medical marijuana drives new medical trials that will eventually define the future of medical marijuana grows. Tech-forward organizations find that controlled cannabis environments increase the quality and quantity of their product. A dynamic and adaptable system future proofs their operation for oncoming regulation. One could infer that the FDA’s 2018 consumer safety guidelines foreshadow the path of manufacturing, testing, and packaging for medical cannabis products.

  • Consumers should consider requesting information on any pesticides, fungicides, fertilizers, or any other residual solvents that could remain on flowers after the cultivation process.
  • Consumers should be sure to inquire about the potency and dosage of an edible product, especially if they are a novice consumer or if the package is not clearly labeled.
  • Safety and quality requires testing for mold, fungus, bacteria, and other microbial organisms. The effects of consuming some of these chemicals, especially in the immunocompromised, could be significant.
  • Flowers and other cannabis products sold to consumers should include cannabinoid profiles on labels, including the content of THC, CBD and other major cannabinoids, and the number and concentration of doses. This is especially important for edible products, which can contain widely varying doses of cannabis.

A Cleaner Future for Medical Marijuana Cultivation

Medical marijuana cultivators understand that control over environmental, genetic, and nutrient variables is an undisputed production advantage for photosynthetic plants. Like all cleanroom applications, the cost-benefit analysis is a key requirement for understanding the need for a cleanroom facility. A cleaner future highlights that the potential of losing not just a marijuana plant, but an entire crop, or even a human life, is a core motivation in adapting new technology. 

Pre-engineered, modular design cleanrooms are cost-effective without the inconvenience of conventional “stick-built” construction. Here you can select your ideal cleanroom configuration and get a quote for free.

Learn More About the Cannabis Cleanroom Construction and Design Process

Production Automation (that’s us) works with a network of authorized cleanroom installers such as PortaFab for complete cannabis cleanroom installation services, outfitting, design, testing, and certification. 

Our engineers work closely with you to answer questions, define specifications, draw blueprints and provide affordable cleanroom manufacturing options for not only prefabricated cleanrooms, but also custom built solutions. That means one point of contact, all the way from a clean idea to a world class cleanroom.  

As a broadline distributor and manufacturer’s representative of brands like CleanPro, Portafab, Terra Universal, and more, we expedite turnaround via a network of warehouses, manufacturers, and suppliers across the United States, Canada, Mexico, and Central America.

Sources

(1) http://www.cannabisbusinesstimes.com/article/moisture-matters/

(2) https://www.marijuanaventure.com/emblem-cannabis-growing-canada/

(3) https://www.cannabistech.com/articles/the-use-of-radio-frequency-technology-in-cannabis-cultivation/

(4) http://www.cultivationrooms.com/cmss_files/attachmentlibrary/Case%20Studies/17_Case-Study-Culivation-Rooms-High-Bay-V2.pdf

(5) https://www.nationaljewish.org/about/news/press-releases/2012/marijuanagrowhouses

(6) http://www.cannabisbusinesstimes.com/article/cbt-062716-colorado-medical-testing-requirements/

(7) https://www.researchgate.net/publication/12181349_Fungal_Contamination_of_Tobacco_and_Marijuana

(8) http://www.clinicalmicrobiologyandinfection.com/article/S1198-743X(16)30605-X/fulltext