Tag Archives: laboratories

Cannabis Manufacturing Considerations: From Raw Materials to Finished Goods

By David Vaillencourt, Kathleen May
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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.

2021 Cannabis Labs Virtual Conference: September Program

By Cannabis Industry Journal Staff
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2021 Cannabis Labs Virtual Conference: September Program

Click here to watch the recording

Agenda

Hemp & Delta-8 in the United States: The Evolution of the Hemp Testing Market

  • Charles Deibel, President & CEO, Deibel Labs, Inc.

In this session, Charles Deibel discusses the current state of affairs across the country with respect to hemp testing. This includes a look at hemp testing rules at the state and federal level. He also provides an in-depth analysis on delta-8 THC and the controversy surrounding this cannabinoid, how to analyze samples of it and why the market has exploded around this product.

TechTalk: Hardy Diagnostics

  • Jessa Youngblood, Food & Beverage Marketing Coordinator, Cannabis Industry Specialist, Hardy Diagnostics

ISO 17025 Accreditation is NOT the Golden Ticket

  • Kathleen May, Founder & Owner, Triskele Quality Solutions

This presentation discusses where the standard falls short, how poor lab practices may negatively impact the consumer and how poor or insufficient lab practices could result in regulatory action, including product recalls, fines, and loss of licenses.

TechTalk: ANAB

  • Melanie Ross, Technical Products Developer, ANSI National Accreditation Board (ANAB)

TechTalk: Columbia Labs

  • Kelly O’Connor, Sales Director Key Accounts, Columbia Labs

Pesticides in Hemp: Challenges and Solutions

  • Grace Bandong, Business Unit Manger for Contaminants, Eurofins Food Chemistry Testing (EFCT)

This presentation takes a deep dive into understanding the requirements for pesticide testing, approaches to analysis and responding to regulatory requirements with extremely low LOQs.

TechTalk: Perkin Elmer

  • Tim Cooper, Sr. Manager, Software Development, PerkinElmer

This presentation provides an overview of how standards are developed and used, how Official Methods for cannabis are developed as well as training opportunities and proficiency testing.

What to Expect When Opening a Lab in a New State

  • Michael Kahn, Founder & CEO, MCR Labs

Kahn explores the lab’s role int he cannabis industry, the importance of knowing and understand state regulations and lessons for growing your lab while maintaining quality.

Click here to watch the recording

Colorado to Bolster Hemp Testing Rules, Rollout Delayed

By Aaron G. Biros
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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.”

ACS Laboratory Launches Tested Safe Certified Seal Program

By Cannabis Industry Journal Staff
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ACS Laboratory, a cannabis and hemp testing lab based outside of Tampa Bay, Florida, announced the launch of their “Tested Safe Certified Seal” program. The program is designed to help raise standards and put more consumer trust in safe, tested products.

The “Tested Safe Certified Seal” on a hemp oil product

ACS Laboratory is an ISO 17025-accredited and DEA-licensed cannabis testing company founded in 2008. Last year they were certified by the Florida Department of Health to perform cannabis testing for state-licensed cannabis companies. In addition, the company acquired Botanica Testing, Inc. in 2020, adding more than 500 hemp and CBD clients to their portfolio. They now perform hemp testing for clients in more than 44 states.

The “Tested Safe Certified Seal” program allows companies to adorn their products with the trademarked seal following testing, informing consumers that their product has met safety standards and a full panel of compliance tests. “Unlike a mandated QR code that links to a Certificate of Analysis (COA) with detailed test results, the Seal shows visual proof at a glance that consumers can trust a brand,” reads the press release.

The program is also endorsed by the American Cannabinoid Association (ACA). “It is exciting to see our industry legally providing cannabis and cannabis-derived products on a commercial scale,” says Matthew Guenther, founder of the ACA. “As with any consumer product, safety and quality control remain our absolute priority.”

To earn the seal, companies send their products to the ACS lab for a full panel of safety and potency tests. ACS has a scope of services that includes: potency testing for 21 cannabinoids, 38 terpene profiles, 42 residual solvents, screening for 105 pesticides, moisture content, water activity, microbiology panels, heavy metals screening, flavonoid testing for 16 profiles, micronutrient testing, mycotoxins, Vitamin E acetate, shelf life & stability, plant regulators (PGRS), PAH testing and Pharmacokinetic Studies (PK) aka human trials.

Kaycha Labs Joins NIST’s CannaQAP

By Cannabis Industry Journal Staff
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Kaycha Labs, a cannabis lab testing company headquartered in Fort Lauderdale, Florida, has announced their participation in the National Institute of Standards and Technology’s (NIST) Cannabis Quality Assurance Program (CannaQAP).

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.

ASTM Proposes New Standard on Change Control Process Management

By Cannabis Industry Journal Staff
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Change control, when it comes to quality management systems in manufacturing, processing and producing products such as cannabis edibles or vape pens, is a process where changes to a product or production line are introduced in a controlled and coordinated manner. The purpose of change control process management is to reduce the possibility of unneeded changes disrupting a system, introducing errors or increasing costs unnecessarily.

ASTM International, the international standards development organization, is developing a new standard guide that will cover change control process management for the cannabis and hemp market. The guide is being developed through the D37 cannabis committee.

The WK77590 guide will establish a standardized method for change control process management for cannabis companies so that they can document and track important decisions in manufacturing and quality systems.

For example, an edibles manufacturer would utilize change control process management if they want to use a different type of processing equipment or introduce a new shape or design of their product. Without change control process management, that edibles producer might switch to a new piece of processing equipment without knowing that it requires more energy or uses different raw materials, thus making production unexpectedly more expensive.

While that’s a very cursory example, the premise is simple: Before you undergo a change to your process, plan it out, analyze it, review it, test it out, implement it and make sure it works.

Change control process management can often be summarized in six steps:

Food processing and sanitation
Change control is designed to coordinate changes to manufacturing so they don’t disrupt a process. 
  1. Plan/Scope
  2. Assess/Analyze
  3. Review/Approval
  4. Build/Test
  5. Implement
  6. Close

Maribel Colón, quality assurance consultant and vice chair of the ASTM subcommittee on cannabis quality management systems, says producers and testing labs will benefit the most from the guide. “As the cannabis industry grows, the quality, expectations, and control challenges grow within,” says Colón. “The creation and implementation of this standard guide will increase cannabis business efficiency and minimize risk, time, and potential cost of poorly managed changes.”

According to a press release, ASTM International is open to collaboration on this as well. Specifically, they are looking for professionals with change control who might be interested in helping advance and develop this guide.

AOAC Approves Two New Microbiological Assays

By Cannabis Industry Journal Staff
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On August 11, PathogenDx announced that they received an AOAC Performance Tested Methods Certificate for their QuantX total yeast and mold test. Six days later, on August 17, Medicinal Genomics announced that AOAC approved their PathoSEEK 5-Color Aspergillus Multiplex Assays under the same AOAC Performance Tested Methods program.

Both assays are specifically designed with cannabis and hemp testing in mind and designed to expedite and simplify microbiological testing. PathogenDx’s QuantX quantifies the total amount of yeast and mold in a sample while also measuring against safety standards.

In addition to the total yeast and mold count test, PathogenDx has also introduced a 96-well plate, improved sample preparation and new data reporting with a custom reporting portal for compliance testing.

The Medicinal Genomics platform can detect four species, including A. flavus, A. fumigatus, A. niger, and A. terreus in both flower and infused edibles. The PathoSEEK microbial testing platform uses a PCR-based assay and provides an internal plant DNA control for every reaction.

This technique verifies the performance of the assay when detecting pathogens, allegedly minimizing false negative results commonly due to set up errors and experimental conditions.

AOAC International is a standards organization that works in the cannabis testing space through their CASP program to evaluate and approve standard testing methods for the industry.

Reducing Cross Contamination in Your Lab

By Nathan Libbey
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Cross Contamination

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
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.

Mariam Webster (2021. Cross contamination. Retrieved from https://www.merriam-webster.com/dictionary/cross%20contamination

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

4 Trends Propelling the U.S. Cannabis Testing Market: 2021-2027

By Priya Deshmukh
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As the legalization of cannabis in the U.S. continues to grow, stringent regulatory requirements around the country are being adopted to ensure that only safe and high-quality cannabis is sold. The U.S. cannabis testing market is estimated to see tremendous growth over the coming years. Further, the FDA has made several resources available for addressing cannabis products like CBD to ensure that consumers and stakeholders are getting safe products.

According to Global Market Insights, Inc., U.S. Cannabis testing market size is projected to surpass USD 4.1 billion at a CAGR of 10.4% through 2027, in light of below mentioned trends:

Strategic initiatives by major industry players

HPLC (high pressure liquid chromatography) instrument.

Prominent players operating in the U.S. cannabis testing market such as CannaSafe, Anresco, Collective Wellness of California, EVIO Inc., Digipath Inc., PSI Labs, SC Labs, Inc., Steep Hill, Inc. etc. are focusing on developing enhanced cannabis testing solutions and accreditation for gaining strong market presence. For example, earlier this year SC Labs developed a comprehensive hemp testing panel that is purported to meet testing standards in every state with a hemp program.

Citing another instance, in 2019, a leading cannabis resource Leafly, introduced the Leafly Certified Labs Program, under which a network of labs is independently assessed by Leafly for quality and accuracy. This program has been designed to address inconsistency in cannabis testing by ensuring that lab data comes from labs that have been confirmed to provide accurate results.

Rising adoption of high-pressure liquid chromatography (HPLC) technique

A lot of cannabis testing procedures are carried out using liquid chromatography. It is estimated to witness higher preference over the coming years. In 2020, the liquid chromatography segment recorded a valuation of USD 662.4 million. Further, liquid chromatography is a valuable alternative to gas chromatography when it comes to analysis of cannabinoids, pesticides and THC which is why this technology is often preferred for potency testing as it offers more precise analysis. Moreover, purification standards are highly controlled in liquid chromatography which helps in obtaining accurate results, which is complementing the segment growth.

Growing popularity of heavy metals testing for cannabis

Cannabis samples are liquified in strong acid in a pressurized microwave prior to evaluation for heavy metal content. Image courtesy of Digipath, Inc.

Heavy metals are known to be one of the major contaminants found in cannabis and its products apart from residual solvents, microbial organisms and pesticides. In addition, heavy metals are highly toxic in nature and on exposure can lead to poisoning and other complications. As a result, heavy metal testing for cannabis and its products is increasingly becoming popular. Several government organizations have made heavy metal testing mandatory for cannabis products. Moreover, increasing legalization of cannabis across several countries for adult use and medical purposes is likely to instigate the demand for heavy metal testing of cannabis products, thereby fostering the growth of heavy metals testing segment over the coming years. For the record, in 2020, the segment had recorded a market revenue of USD 352.5 million.

Increasing support from government bodies in the Mountain West

With increasing legalization for medical and adult use, the cannabis testing market in the Mountain West zone of the U.S. is likely to observe a tremendous growth over time. Moreover, growing support from various government bodies is playing a key role in enhancing the business space. For example, Montana’s Department of Revenue helps labs get licensed along with the state’s environmental laboratory that oversees inspections and licensing. Further, presence of a large number of cultivators of cannabis and manufacturers of cannabis-based products are also positively influencing the regional market growth. Considering the significance of these growth factors, the U.S. cannabis testing market in the Mountain West is estimated to register a substantial CAGR of 9.6% through 2027.

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.