Tag Archives: facilities

Flooring Tips for Cannabis Growing Facilities

By Sophia Daukus
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In the burgeoning cannabis market, grow facilities are facing more and more competition every day. New indoor cultivation enterprises are often being set up in formerly vacant industrial buildings and commercial spaces, while in other cases, companies are planning and constructing new grow facilities from the ground up. For all these establishments, continually lowering production costs while supplying the highest possible quality in ever-increasing yields is the way forward.

Whether in existing or new structures, concrete floors are ubiquitous throughout the majority of cannabis growing facilities. With the right treatment, these indoor concrete traffic surfaces can greatly contribute to a company achieving its operational objectives. Alternatively, insufficiently protected concrete floors can create annoying and costly barriers to accomplishing company goals.

Challenges in Cannabis Grow Facility Construction

As with any emergent industry, mainstream acceptance and market growth is bringing regulation to cannabis cultivation. Local governments are paying more attention to how cannabis growing facilities are constructed and operated. In addition to the standard business matters of building safety, employee working conditions and tax contributions, elected officials are increasingly under pressure from constituents to analyze the overall effect of grow facilities on their communities at large.

High consumption of energy for grow room lights and high water usage are just part of the equation. The temperature and humidity needs of a grow facility can be similar to that of an indoor swimming pool environment. While warmth and moisture are ideal for cannabis growth, they also provide the ideal conditions for the growth and proliferation of fungi and other undesirable microorganisms. Therefore, to help preserve plant health in the moist indoor climate, fumigation often comes into play.

Carbon dioxide (CO2) enrichment of grow room air, a common practice proven to increase crop yields, presents another set of safety and health considerations in dense urban environments.

Adding to these challenges, many cannabis grow facilities are producing plants destined for either pharmacological or nutritional use. This in itself demands scrutiny by regulators for the sake of the consuming public.

As a result, grow room managers and owners must stay informed about the evolution of the industry in terms of local and federal agency regulations concerning their facilities, their overall operation and their products.

Bare Concrete Floors in Grow Rooms

As a foundational construction material, concrete continues to lead the way in commercial and industrial construction. Despite the many advantages of concrete floors, when left unprotected they can present significant challenges specific to cannabis grow rooms.

  • Untreated, bare concrete is naturally porous, easily absorbing liquids and environmental moisture. Substances found in grow rooms, such as fertilizers, fungicides and other chemicals, can leach through the porous concrete floor slab into the soil and ground water. Whether organic or synthetic, concentrations of such substances can be highly detrimental to the surrounding environment.
  • Whether in an existing or newly constructed facility, it is not uncommon for the under-slab vapor barrier to be compromised during construction. When this occurs, moisture from the soil beneath the floor slab can enter the concrete and move osmotically upward, creating a phenomenon known as Moisture Vapor Transmission (MVT). The resulting moisture and moisture vapor tends to become ever more alkaline as it rises upward through the concrete slab. MVT can result in blistering, bubbles and other damage to floor coverings.
  • The warm temperatures, regular watering of plants and high relative humidity maintained within many grow rooms can contribute to a weakening of the structural integrity of unprotected grow room slabs.
  • Within the confined space of a grow room, the warm, moist air invites microbe proliferation. Food and pharmaceutical plants are high on the priority list when it comes to facility hygiene levels, as demanded by code.

Public health guidelines for cannabis cultivation facilities in various parts of the country are increasingly mirroring those of food processing. Typical requirements include having smooth, durable, non-absorbent floor surfaces that are easily cleaned and in good repair, possessing proper floor slope towards a sanitary floor drain, with no puddling, as well as an integral floor-to-wall cove base. These directives cannot be met with bare concrete alone.

Optimal Grow Room Flooring Performance

In some locations, cannabis growing facilities are already subject to strict building codes and regulations. This will no doubt be spreading to other regions in the near future. For example, the Public Health Agency of Los Angeles County publishes construction guidelines to ensure cannabis facility floors meet standards mirroring the food processing and pharmaceutical manufacturing industries, where sanitation, facility hygiene and safety are paramount. In these types of facilities, bare, unprotected concrete floor slabs are not allowed as a general rule, due to the material’s innate porosity and absorbency.

Flooring in grow rooms, like in their food and pharma industry counterparts, should optimally:

  1. Provide a monolithic and virtually seamless surface to help eliminate crevices, grout lines and other dark, damp locations where soil and pathogens tend to hide
  2. Be impervious and non-porous, providing a surface that can isolate toxic materials on the surface for proper clean-up where needed
  3. Enable correction or improvement of the floor slope for proper drainage, with no low spots to help avoid puddling
  4. Be installed with integral floor-to-wall cove options for easier wash-down and sanitizing
  5. Have the strength and thermal shock resistance, plus the tenacious bond, to undergo steam-cleaning and/or hot power washing, where needed
  6. Enable seamless, continuous surface installation over concrete curbs and containment areas
  7. Offer antimicrobial options for highly sensitive locations
  8. Demonstrate high compressive strength and impact resistance for durability under heavy loads
  1. Display excellent abrasion resistance, allowing the system to perform under grueling daily wear-and-tear
  2. Present customizable slip-resistance options that can be balanced with easy clean-ability
  3. Facilitate the use of floor safety markings, such as color-coded traffic and work area designations
  1. Be formulated with low odor, low-VOC chemistries that meet all EPA and similar regulations
  2. Be able to contribute LEED Green Building Credits, where desired
  3. Include options for refurbishing old or damaged concrete surfaces to allow reuse of existing facility resources, as opposed to having to be demolished, thus unnecessarily contributing to landfill waste
  4. Withstand and perform in continually damp grow room conditions, without degrading
  5. Be compliant with FDA, USDA, EPA, ADA, OSHA, as well as local regulations and/or guidelines
  6. Include MVT mitigating solutions where Moisture Vapor Transmission site issues are present
  7. Provide waterproofing underlayment options for multi-story facilities
  8. Demonstrate excellent resistance to a broad range of chemicals, fertilizers and extreme pH substances

Finding an affordable floor system with all the above features may seem like a tall order. Luckily, innovative manufacturers now offer cannabis facility flooring that meets sanitation, regulatory compliancy, durability and budgetary needs of growers.

Resinous Flooring Value for Cannabis Facilities

Choosing the right floor solutions for a given cultivation facility may be one of the most important decisions an owner or manager makes. Since floors are present throughout the structure, poor selection and compromised protection of concrete slabs can end up wreaking havoc with profits and yields over time.

Few facilities can afford the inconvenience and expense of an otherwise unnecessary floor repair or replacement. Having to suddenly move cumbersome plant beds and heavy pots in order to give workers access to the floor area can be headache. In addition, the unscheduled downtime and overall juggling of resources that invariably must take place make a strong case for investing in optimal grow room flooring from the start.

An excellent long-term value, professional-grade resinous floor systems present cannabis growers with a unique set of solutions for cultivation rooms. Not only does this type of flooring offer all the desirable features listed above, but also furnish a host of added benefits to grow room operations, including:

Very High Gloss Finish

  • Highly reflective floor surfaces enable light entering the space from overhead to bounce back upward, exposing the underside of leaves to the light and potentially increasing yields
  • Exceptionally high gloss floor finishes in light colors help make the most of your existing lighting sources, significantly increasing room illumination
  • Achieving greater illumination without adding fixtures helps reduce energy consumption and associated costs

Virtually Seamless Surface

  • Fluid-applied resin-based flooring provides an impermeable, monolithic surface that is exceptionally easy to clean and maintain
  • The virtually seamless finish of resinous coated floors greatly reduces the number of locations for soil, pathogens and microbes to gather
  • Resinous floors, by incorporating integral cove bases to eliminate ninety degree angles, correcting floor slope to eliminate puddling, and allowing for a virtually seamless surface, provide an optimally sanitary flooring solution

Outstanding Moisture Tolerance

  • Designed specifically for use in wet industrial environments, cementitious urethane flooring is a top choice for humid grow rooms
  • Also called “urethane mortar”, this type of floor can help mitigate certain undesirable site conditions, such as Moisture Vapor Transmission (MVT)

Chemical, Acid and Alkali Resistance

  • Whether organic or synthetic, many soil enhancers and substances used to eradicate undesirable fungi and pests can damage concrete and shorten the usable life of foundational slabs
  • Protecting concrete slabs with monolithic, non-absorbent and appropriately chemical resistant coating systems allows concrete to perform as designed, for as long as intended
  • A proper barrier coating on the floor allows spilled or sprayed substances to be properly cleaned up and disposed of, rather than allowing the liquids to seep through the porous slab, and into the surrounding natural environment

Added Safety

  • Resinous coating systems’ slip-resistance is completely customizable at the time of installation, enabling growers to request more traction in pedestrian walkways and less slip-resistance under raised beds.
  • Epoxy, urethane and polyaspartic resinous flooring systems accommodate the installation of safety and line markings, as well as varying colors to delineate specific work areas
  • The antimicrobial flooring options available from some manufacturers offer further hygiene support in highly sensitive facilities
  • Today’s industrial resinous floor coatings from reputable suppliers are very low to zero V.O.C. and compliant with EPA and other environmental regulations

Resinous coating systems provide ideal value to informed growers who require durable, reliable and long-lasting high performance flooring for their facilities.

Support from the Ground Up

From incredible medical advances to high tensile fiber in construction materials, the expanding cannabis industry is bringing exciting opportunities to many areas of the economy. As more and more growers enter the market, so increases the pressure to compete.

By choosing light reflective, seamless and moisture tolerant resinous flooring that meets regulatory guidelines for grow rooms, managers can help reduce their overhead costs on multiple fronts — and get a jump on the competition.

Disposable Gloves: The Unregulated Cannabis Threat

By Lynda Ronaldson
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Today in the states where medical and recreational cannabis is legal, cannabis products purchased from licensed facilities are required to have undergone testing by accredited labs. The compliance testing verifies advertised potency levels and checks for microbial contamination, herbicides, pesticides, fungicides and the presence of mold and mildew, among other potential contaminants.

Until recently, little attention has been given to disposable gloves and their possible involvement in the contamination of the products they handle.  What factors should you consider when purchasing gloves?

Disposable Gloves Facts

Disposable gloves, like cannabis products, are not made of equal quality. There are several different types of disposable gloves on the market, and huge variations in glove quality and chemical compositions exist between and within each glove type.

Recent scientific studies have revealed how gloves produced in factories with poor manufacturing standards and raw material ingredients can contaminate the products they handle. High-level toxins in disposable gloves were found to affect lab results, toxins in gloves contaminated the food they touched, and pathogen contamination of unused disposable gloves has been proven. Should the cannabis industry take more interest in the disposable gloves they are using? With so much at stake if compliance test results are compromised, we think so!

Glove Procurement: Factors to Consider

What factors should you consider when purchasing gloves?

  1. Industrial grade gloves- There is no such thing as an industrial grade glove certification, although it does give an incorrect impression that gloves are strong and resilient. Industrial grade means they have not been subjected to inspection nor have passed any specific testing requirements.
  2. Food contact gloves are certified under FDA Title 21 CFR Part 177, which states the components of the glove comply with the FDA regulations and the gloves consist of “substances generally recognized as safe for use in food or food packaging.” Few controls exist for glove manufacturing relating to the reliability of raw materials and manufacturing processes, and costs can be reduced with the use of cheap, toxic materials.
  3. Medical grade gloves have to pass a series of technical tests in order to meet the safety requirements specified by the FDA. Gloves are tested for puncture and abrasion resistance, must meet tension and elongation tests and are also tested for chemical substance resistance. Manufacturers of these gloves must receive 510k certification. As this study shows, even medical gloves can contain high levels of toxic ingredients, affecting laboratory test results.
  4. The Acceptable Quality Level (AQL) refers to a quality standard for measuring pinhole defects- the lower the AQL, the less defects the gloves have. There are no AQL requirements for food grade or industrial grade gloves, meaning there are no guidelines for the number of failures per box. Medical grade gloves must have an AQL of 2.5 or less, meaning 2.5 failed gloves per 100 gloves is an acceptable level.
  5. For Californian cannabis companies, are your disposable gloves Prop. 65 compliant? Accelerator chemicals, such as 2-Mercaptobenzothiazole (MBT) found in some nitrile gloves, have recently been added to the Prop. 65 chemicals known to cause cancer.

How Gloves Can Contaminate Products

Physical, chemical and microbiological hazards have been identified in disposable glove supply chains. Gloves of any grade are not tested for cleanliness (microbial and bioburden levels), raw material toxicity and chemical composition, or pathogen contamination.

100% of glove factories supplying the United States are based in Southeast Asia. These factories are generally self­-regulated, with FDA compliance required for a rough outline of the ingredients of the gloves rather than the final product. Few controls are required for glove manufacturing relating to the reliability of raw materials, manufacturing processes and factory compliance or conditions. A clear opportunity exists for accidental or intentional contamination within the glove-making process, especially to reduce costs.

In order to safeguard their customers from product contamination, a selection of tests and certifications, some of which are unique within the glove industry, are being implemented by glove supplier Eagle Protect. These tests make sure Eagle’s gloves coming into the United States are made in clean, well run factories, free of any type of contamination and are consistent in material makeup to original food safe specifications. This glove Fingerprint testing program, consists of a number of proprietary risk reduction steps and targeted third-party testing methods, includes gas chromatography combined with mass spectroscopy (GC/MS); surface free energy determination; in vitro cytotoxicity analysis; and microbial viability-linked metagenomic analysis.

With a great deal of faith placed on a glove supplier’s ability to deliver disposable gloves sight unseen, we believe these tests are essential to further reduce risks or pathogen contamination associated with them, keeping your cannabis products safe.

Food processing and sanitation

Sanitation Starting Points: More Than Sweeping the Floors and Wiping Down the Table

By Ellice Ogle
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Food processing and sanitation

Sanitation is not just sweeping the floors and wiping down the table – sanitation has a wide-ranging function in a cannabis food manufacturing facility. For example, sanitation covers the employees (and unwanted pests), food-contact equipment (and non-food-contact equipment), trash disposal (including sewage), and more. Ultimately, sanitation systems maintain a clean environment to prevent foodborne illness from affecting human health. Fortunately, there are resources and tools to ease into establishing a robust sanitation program.

Overall, the main goal of sanitation is to produce safe food, to keep consumers healthy and safe from foodborne illness. With the cannabis industry growing and gaining legalization, cannabis reaches a larger, wider audience. This population includes consumers most vulnerable to foodborne illness such as people with immunocompromised systems, the elderly, the pregnant, or the young. These consumers, and all consumers, need and deserve safe cannabis products every experience.

FDAlogoTo produce safe food, food manufacturing facilities in the United States must at least follow the Food and Drug Administration (FDA)’s Code of Federal Regulations Title 21 Chapter I Subchapter B Part 117, current good manufacturing practice, hazard analysis, and risk-based preventive controls for human food. Although cannabis is currently not federally regulated, these regulations are still relevant for a cannabis food manufacturing facility since the same basic principles still apply. Also, these regulations are a good resource to simplify a comprehensive sanitation program into more manageable components, between sanitary operations and sanitary facilities. With more manageable components, the transition is smoother to then identify the appropriate tools that will achieve a thorough sanitation program.

Sanitary operations

1) General maintenance of the facilities: The buildings and fixtures of the food manufacturing facility cover a lot of ground – hiring a maintenance team will divide the responsibility, ensuring the entire facility can be maintained in a clean and sanitary condition. Furthermore, a team can build out a tool like a preventative maintenance program to restrict issues from ever becoming issues.

Figure 1: Dirty Cloth Towel in Dirty “Sanitizer” Solution
Dirty Cloth Towel in Dirty “Sanitizer” Solution (an example of what NOT to do)

2) Control of the chemicals used for cleaning and sanitizing: Not all chemicals are equal – select the appropriate cleaning and sanitizing chemicals from reputable suppliers. Obtain the right knowledge and training on proper use, storage, and proper protective equipment (PPE). This ensures the safe and effective application of the chemicals in minimizing the risk of foodborne illness.

3) Pest control: Understand the environment within the facility and outside the facility. This will aid in identifying the most common or likely pests, in order to focus the pest control efforts. Keep in mind that internal pest management programs can be just as successful as hiring external pest control services.

4) Procedures for sanitation of both food-contact and non-food-contact surfaces: Developing sanitation standard operating procedures (SSOPs) provides guidance to employees on appropriate cleaning and sanitizing practices, to balance effective and efficient operations. A master sanitation schedule can control the frequency of indicated sanitation procedures.

5) Storage and handling of cleaned portable equipment and utensils: Cross contamination in storage can be minimized with tools such as controlled traffic flow, signage, training, color coding, and more.

Sanitary facilities

6) Water supply, plumbing, and sewage disposal: Routine inspections of plumbing, floor drainage, and sewage systems prevent unintended water flow and damage.

7) Toilet facilities: Clearly defining standards for the toilet facilities and setting accountability to everyone who uses them will ensure that the toilet facilities are not a source of contamination for the food products.

Food processing and sanitation
PPE for all employees at every stage of processing is essential

8) Hand-washing facilities: Good manufacturing practices (GMPs) include proper hand washing and proper hand washing starts with suitable hand-washing facilities. For example, frequent checks on running water, hand soap, and single use towels ensure that all hands are clean and ready to produce safe food.

9) Trash disposal: While trash can be a source of cross contamination, trash can also attract and harbor pests. Scheduling regular trash disposal and controlling traffic flow of waste are two ways to minimize the risk of cross contamination from trash.

Bonus

Even after meeting these requirements, sanitation programs can be more sophisticated. An example is to institute an environmental monitoring program to verify and validate that the sanitation program is effective. Another example is in identifying and measuring key performance indicators (KPIs) within the sanitation program that can improve not just the sanitation processes, but the operations as a whole. Principally, sanitation is cleanliness on the most basic level, but waste management can encompass sanitation and grow into a larger discussion on sustainability. All in all, sanitation programs must reshape and evolve alongside the company growth.

Sanitation is interwoven throughout the food manufacturing process; sanitation is not a single task to be carried out by a sole individual. As such, it is beneficial to incorporate sanitation practices into cannabis food manufacturing processes from the beginning. Protect your brand from product rework or recalls and, most importantly, protect your consumers from foodborne illness, by practicing proper sanitation.

Cannabis Facility Construction Retrofitting Buildings for Processing, Growing

By Aaron G. Biros
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Cannabis Facility Construction (CFC), based in Northbrook, Illinois, has taken a rather unique approach to facility design and building in the cannabis market. According to a press release published today, the company takes unused buildings and remodels them into facilities designed specifically for the cannabis industry.

A 5,200 square foot CFC-built dispensary in Morris, Illinois.

CFC, which is a division of Mosaic Construction, retrofits unused, abandoned buildings, turning them into cannabis cultivation and processing facilities, as well as dispensaries. According to that press release, they have developed buildings on 28 different facilities to date, covering over 328,970 square feet.

The Litchfield, Illinois cultivation facility, remodeled by CFC

According to Ira Singer, Principal at CFC, they provide a turnkey service for licensed operations to retrofit old buildings, including staying compliant with state cannabis regulations. “Since the cannabis industry is emerging as a growth market, investors need to appreciate there is an art and a science to converting raw materials of cannabis and finished products,” says Singer. “CFC’s medicinal processing centers are outfitted to master the product in all its forms and uses, and to meet all state regulations and local fire and safety codes. Its three-stage approach encompasses its Design-Build expertise for processing facilities; construction management; security infrastructure and planning; and permitting and compliance support.”

For example, they helped investors from Highland Park, Illinois take an unused building in Garden City, Michigan and convert it into a 48,000 square foot cultivation, processing and dispensary facility. CFC also does business with Greenhouse, a medical cannabis company with facilities throughout Illinois.

For more information and to see some of their work, check out their portfolio here.

control the room environment

Environmental Controls: The Basics

By Vince Sebald
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control the room environment

The outside environment can vary widely depending on where your facility is located. However, the internal environment around any activity can have an effect on that activity and any personnel performing the activity, whether that’s storage, manufacturing, testing, office work, etc. These effects can, in turn, affect the product of such activities. Environmental control strategies aim to ensure that the environment supports efforts to keep product quality high in a manner that is economical and sensible, regardless of the outside weather conditions.

For this article, let us define the “environment” as characteristics related to the room air in which an activity is performed, setting aside construction and procedural conditions that may also affect the activity. Also, let us leave the issue of managing toxins or potent compounds for another time (as well as lighting, noise, vibration, air flow, differential pressures, etc). The intent here is to focus on the basics: temperature, humidity and a little bit on particulate counts.

Temperature and humidity are key because a non-suitable environment can result in the following problems:

  • Operator discomfort
  • Increased operator error
  • Difficulty in managing products (e.g. powders, capsules, etc)
  • Particulate generation
  • Degradation of raw materials
  • Product contamination
  • Product degradation
  • Microbial and mold growth
  • Excessive static

USP <659> “Packaging and Storage Requirements” identifies room temperature as 20-25°C (68-77 °F) and is often used as a guideline for operations. If gowning is required, the temperature may be reduced to improve operator comfort. This is a good guide for human working areas. For areas that require other specific temperatures (e.g. refrigerated storage for raw materials), the temperature of the area should be set to those requirements.

Humidity can affect activities at the high end by allowing mold growth and at the low end by increasing static. Some products (or packaging materials) are hydroscopic, and will take on water from a humid environment. Working with particular products (e.g. powders) can also drive the requirement for better humidity control, since some powders become difficult to manage in either high or low humidity environments. For human operations without other constraints, a typical range for desirable humidity is in the range of 20 to 70% RH in manufacturing areas, allowing for occasional excursions above. As in the case of temperature, other requirements may dictate a different range.

control the room environment
In some cases, a locally controlled environment is a good option to reduce the need to control the room environment as tightly or to protect the operator.

In a typical work environment, it is often sufficient to control the temperature, while allowing the relative humidity to vary. If the humidity does not exceed the limits for the activity, then this approach is preferred, because controlling humidity adds a level of complexity (and cost) to the air handling. If humidity control is required, it can be managed by adding moisture via various humidification systems, or cooling/reheating air to remove moisture. When very low humidity is required, special equipment such as a desiccant system may be required. It should be noted that although you can save money by not implementing humidity control at the beginning, retrofitting your system for humidity control at a later time can be expensive and require a shutdown of the facility.

Good engineering practice can help prevent issues that may be caused by activities performed in inappropriately controlled environments. The following steps can help manage the process:

  • Plan your operations throughout your facility, taking into account the requirements for the temperature and humidity in each area and know what activities are most sensitive to the environment. Plans can change, so plan for contingencies whenever possible.
  • Write down your requirements in a User Requirement Specification (URS) to a level of detail that is sufficient for you to test against once the system is built. This should include specific temperature and RH ranges. You may have additional requirements. Don’t forget to include requirements for instrumentation that will allow you to monitor the temperature and RH of critical areas. This instrumentation should be calibrated.
  • Solicit and select proposals for work based on the URS that you have generated. The contractor will understand the weather in the area and can ensure that the system can meet your requirements. A good contractor can also further assist with other topics that are not within the scope of this article (particulates, differential pressures, managing heating or humidity generating equipment effects, etc).
  • Once work is completed, verify correct operation using the calibrated instrumentation provided, and make sure you add periodic calibration of critical equipment, as well as maintenance of your mechanical system(s), to your calibration and maintenance schedules, to keep everything running smoothly.

The main point is if you plan your facility and know your requirements, then you can avoid significant problems down the road as your company grows and activity in various areas increases. Chances are that a typical facility may not meet your particular requirements, and finding that out after you are operational can take away from your vacation time and peace of mind. Consider the environment, its good business!

The Necessity of Food Safety Programs in Cannabis Food Processing

By Gabe Miller
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When processing cannabis, in any form, it is critical to remember that it is a product intended for human consumption. As such, strict attention must also be paid to food safety as well. With more and more states legalizing either medical or recreational cannabis, the potential for improper processing of the cannabis triggering an illness or death to the consumer is increasing.

The FDA Food Safety Modernization Act (FSMA) is the new food safety law that has resulted in seven new regulations, many which directly or indirectly impact the production and processing of cannabis. Under FSMA regulations, food processors must identify either known or reasonably foreseeable biological, chemical or physical hazards, assess the risks of each hazard, and implement controls to minimize or prevent them. The FSMA Preventive Controls for Human Foods (PCHF) regulation contains updated food “Good Manufacturing Practices (cGMPs) that are in many cases made a requirement in a state’s medical or recreational cannabis laws. These cGMPs can be found in 21 CFR 117 Subpart B.

It is imperative that cannabis manufacturers have a number of controls in place including management of suppliers providing the raw material.Food safety risks in cannabis processing could originate from bacteria, cleaning or agricultural chemicals, food allergens or small pieces of wood, glass or metal. The hazards that must be addressed could be natural, unintentionally introduced, or even intentionally introduced for economic benefit, and all must be controlled.

It is unlikely that high heat, used in other food products to remove bad bacteria would be used in the processing of cannabis as many of its desirable compounds are volatile and would dissipate under heating conditions. Therefore, any heat treatment needs to be carefully evaluated for effectiveness in killing bacterial pathogens while not damaging the valuable constituents of cannabis. Even when products are heated above temperatures that eliminate pathogens, if the raw materials are stored in a manner that permits mold growth, mycotoxins produced by molds that have been linked to cancer could be present, even after cooking the product. Storage of raw materials might require humidity controls to minimize the risk of mold. Also, pesticides and herbicides applied during the growth and harvesting of cannabis would be very difficult to remove during processing.

It is imperative that cannabis manufacturers have a number of controls in place including management of suppliers providing the raw material. Other controls that must be implemented include proper cannabis storage, handling and processing as well as food allergen control, and equipment/facility cleaning and sanitation practices. Processing facilities must adhere to Good Manufacturing Practices (GMP’s) for food processing, including controls such as employee hand washing and clothing (captive wear, hair nets, beard nets, removal of jewelry, and foot wear) that might contribute to contamination. A Pest Control plan must be implemented to prevent fecal and pathogen contamination from vermin such as rodents, insects, or birds.

Processing facilities must be designed for proper floor drainage to prevent standing water. Processing air should be properly filtered with airflow into the cannabis processing facility resulting in a slightly higher pressure than the surrounding air pressure, from the clean process area outwards. Toilet facilities with hand washing are essential, physically separated from the process areas. Food consumption areas must also be physically separate from processing and bathroom areas and have an available, dedicated hand sink nearby. Employee training and company procedures must be effective in keeping food out of the processing area. Labels and packaging must be stored in an orderly manner and controlled to prevent possible mix-up.Cleaning of the processing equipment is critical to minimize the risk of cross contamination and microbial growth.

Written food safety operational procedures including prerequisite programs, standard operating procedures (SOP’s), etc. must be implemented and monitored to ensure that the preventive controls are performed consistently. This could be manual written logs, electronic computerized data capture, etc., to ensure processes meet or exceed FSMA requirements.

A written corrective action program must be in place to ensure timely response to food safety problems related to cannabis processing problems when they occur and must include a preventive plan to reduce the chance of recurrence. The corrective actions must be documented by written records.

Supply chain controls must be in place. In addition, a full product recall plan is required, in the event that a hazard is identified in the marketplace to provide for timely recall of the contaminated product.

Cleaning of the processing equipment is critical to minimize the risk of cross contamination and microbial growth. The processing equipment must be designed for ease of cleaning with the minimum of disassembly and should conform to food industry standards, such as the 3-A Sanitary Standards, American Meat Institute’s Equipment Standards, the USDA Equipment Requirements, or the Baking Industry Sanitation Standards Committee (BISSC) Sanitation Standards ANSI/ASB/Z50.2-2008.

Serious food borne contaminations have occurred in the food industry, and cannabis processing is just as susceptible to foodborne contamination. These contaminations are not only a risk to consumer health, but they also burden the food processors with significant costs and potential financial liability.

Anyone processing cannabis in any form must be aware of the state regulatory requirements associated with their products and implement food safety programs to ensure a safe, desirable product for their customers.

California Manufacturing Regulations: What You Need To Know

By Aaron G. Biros
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In late November, California released their proposed emergency regulations for the cannabis industry, ahead of the full 2018 medical and adult use legalization for the state. We highlighted some of the key takeaways from the California Bureau of Cannabis Control’s regulations for the entire industry earlier. Now, we are going to take a look at the California Department of Public Health (CDPH) cannabis manufacturing regulations.

According to the summary published by the CDPH, business can have an A-type license (for products sold on the adult use market) and an M-type license (products sold on the medical market). The four license types in extraction are as follows:

  • Type 7: Extraction using volatile solvents (butane, hexane, pentane)
  • Type 6: Extraction using a non-volatile solvent or mechanical method
    (food-grade butter, oil, water, ethanol, or carbon dioxide)
  • Type N: Infusions (using pre-extracted oils to create edibles, beverages,
  • capsules, vape cartridges, tinctures or topicals)
  • Type P: Packaging and labeling only

As we discussed in out initial breakdown of the overall rules, California’s dual licensing system means applicants must get local approval before getting a state license to operate.

The rules dictate a close-loop system certified by a California-licensed engineer when using carbon dioxide or a volatile solvent in extraction. They require 99% purity for hydrocarbon solvents. Local fire code officials must certify all extraction facilities.

In the realm of edibles, much like the rule that Colorado recently implemented, infused products cannot be shaped like a human, animal, insect, or fruit. No more than 10mg of THC per serving and 100mg of THC per package is allowed in infused products, with the exception of tinctures, capsules or topicals that are limited to 1,000 mg of THC for the adult use market and 2,000 mg in the medical market. This is a rule very similar to what we have seen Washington, Oregon and Colorado implement.

On a somewhat interesting note, no cannabis infused products can contain nicotine, caffeine or alcohol. California already has brewers and winemakers using cannabis in beer and wine, so it will be interesting to see how this rule might change, if at all.

CA Universal Symbol (JPG)

The rules for packaging and labeling are indicative of a major push for product safety, disclosure and differentiating cannabis products from other foods. Packaging must be opaque, cannot resemble other foods packaged, not attractive to children, tamper-evident, re-sealable if it has multiple servings and child-resistant. The label has to include nutrition facts, a full ingredient list and the universal symbol, demonstrating that it contains cannabis in it. “Statute requires that labels not be attractive to individuals under age 21 and include mandated warning statements and the amount of THC content,” reads the summary. Also, manufacturers cannot call their product a candy.

Foods that require refrigeration and any potentially hazardous food, like meat and seafood, cannot be used in cannabis product manufacturing. They do allow juice and dried meat and perishable ingredients like milk and eggs as long as the final product is up to standards. This will seemingly allow for baked goods to be sold, as long as they are packaged prior to distribution.

Perhaps the most interesting of the proposed rules are requiring written standard operating procedures (SOPs) and following good manufacturing practices (GMPs). Per the new rules, the state will require manufacturers to have written SOPs for waste disposal, inventory and quality control, transportation and security.

Donavan Bennett, co-founder and CEO of the Cannabis Quality Group

According to Donavan Bennett, co-founder and chief executive officer of the Cannabis Quality Group, California is taking a page from the manufacturing and life science industry by requiring SOPs. “The purpose of an SOP is straightforward: to ensure that essential job tasks are performed correctly, consistently, and in conformance with internally approved procedures,” says Bennett. “Without having robust SOPs, how can department managers ensure their employees are trained effectively? Or, how will these department managers know their harvest is consistently being grown? No matter the employee or location.” California requiring written SOPs can potentially help a large number of cannabis businesses improve their operations. “SOPs set the tempo and standard for your organization,” says Bennett. “Without effective training and continuous improvement of SOPs, operators are losing efficiency and their likelihood of having a recall is greater.”

Bennett also says GMPs, now required by the state, can help companies keep track of their sanitation and cleanliness overall. “GMPs address a wide range of production activities, including raw material, sanitation and cleanliness of the premises, and facility design,” says Bennett. “Auditing internal and supplier GMPs should be conducted to ensure any deficiencies are identified and addressed. The company is responsible for the whole process and products, even for the used and unused products which are produced by others.” Bennett recommends auditing your suppliers at least twice annually, checking their GMPs and quality of raw materials, such as cannabis flower or trim prior to extraction.

“These regulations are only the beginning,” says Bennett. “As the consumer becomes more educated on quality cannabis and as more states come online who derives a significant amount of their revenue from the manufacturing and/or life science industries (e.g. New Jersey), regulations like these will become the norm.” Bennett’s Cannabis Quality Group is a provider of cloud quality management software for the cannabis industry.

“Think about it this way: Anything you eat today or any medicine you should take today, is following set and stringent SOPs and GMPs to ensure you are safe and consuming the highest quality product. Why should the cannabis industry be any different?”