Cannabis extraction facilities require a thoughtful design, with detailed planning at every step. The design/build team must take the lab plan layout into consideration when developing these sites, along with site analysis and code compliance; equipment, construction, and workflow plans and schedules; and equipment installation, training, and compliance strategies. Safety is of utmost importance in every lab, and cannabis extraction labs in particular present a unique challenge because of how relatively new they are to the industry.
Lab Manager speaks with Nick Tennant, founder and CTO of Precision Extraction Solutions, to discuss how cannabis extraction facilities are developed, how other industries can inspire optimal results in a cannabis lab’s design plan, and whether the COVID-19 crisis has impacted the future of cannabis lab design.
Q: Does Precision Extraction Solutions normally design new cannabis extraction facilities, renovate existing cannabis extraction facilities, retrofit other types of facilities into cannabis extraction facilities, or some combination of the three? What are the benefits and drawbacks of each, in your experience?
A: Cannabis is a new frontier in terms of an industry, so a vast majority of these extraction facilities are new designs with a few situations of expansion to a production line from, say, 500 pounds to more. There are no opportunities to retro-fit or renovate because no “old” cannabis facilities exist yet, making most of our work new lab builds. The last 10 to 20 percent of what Precision does is rework to fix other people’s mistakes in the design and integration process. We are asked to fix these mistakes because the design is either noncompliant or the facility isn’t hitting production numbers.
There are no real benefits or drawbacks. When building an extraction facility you must ultimately build it to code and meet the specifications. This all has to be completed right the first time, otherwise we get hired to come in and fix it.
Q: How much involvement do lab managers, lab staff, and other end users have in the design process? How do you keep them involved?
A: Lab managers and staff are either very involved or not involved at all—there is no in-between. They are closely involved for brands that are established and employ well-versed lab managers who are already operating within their entities. In this case, our sales team is almost exclusively working with the lab managers and staff to understand their production needs, equipment demand, and how they want to create their production line.
If they are new startups that haven’t hired this staff then they obviously don’t have these people in place, in which case Precision fills the consultancy role to get them pointed in the right direction.
Q: What does the COVID-19 crisis mean for the future of cannabis extraction facility design?
A: The COVID-19 crisis doesn’t affect the lab design whatsoever. Every lab is already in a completely sanitary environment and everyone is already in full PPE gear—space suit, hair net, mask, gloves—to avoid cross contamination of products. There are cleanrooms with the minimal amount of particles flying through the air, and any above the limit are immediately sucked out by ventilation.
It doesn’t change anything for us, including the design. One of the safest places to be during a pandemic would be inside of a lab. There is no social distancing because it’s not of consequence—it doesn’t work like that in a lab setting.
Q: Is there anything particularly unique or groundbreaking about the way you design your facilities?
A: What’s unique about how we design facilities is we take our almost two decades’ worth of experience in the cannabis space and integrate all of that tribal knowledge into the design. That goes into workflow, production management and equipment management, ensuring that the layout of the facility is conducive to creating an environment that inhibits cross-contamination, that will hit its production numbers, and so on. That tribal knowledge is unattainable without working in this industry for a significant period of time or without working thousands of hours in a lab, which teaches you how this all flows together.
Q: Cannabis research and extraction can be a niche field in the US. Where do you go for guidance and resources?
A: When it comes to cannabis research and extraction surrounding the research, the FDA has just recently issued guidance for the manufacturing of research-based products derived from cannabis. I believe that in the future they will issue additional guidance and there will be research-based programs granted from the federal government in order to further cannabis and cannabinoid plant compound research. Therefore, the first place I would start is with the FDA.
Unfortunately, however, it is quite burdensome. We’re really entering the pharmaceutical realm by researching how these individual molecules or the constituents of the cannabis plant apply to treating, curing or alleviating ailments in human disease. Such claims are subject to the FDA and pharmaceutical manufacturing requirements like USP or CGMT, which are pretty strict. If you’re in a cannabis research space driving towards drug development to treat any sort of disease or condition, you must have a big budget.
This is where pharma comes in. Many pharmaceutical companies are undergoing clinical trials for different cannabinoid compounds to push through the FDA. Precision currently works with some of these companies because we have a great deal of knowledge on the process and can guide them as they progress.
Q: How do you stay on top of state and local laws and regulations?
A: Over the past decade or so, we’ve built a repository of all state laws and regulations. They change from time to time but what is most relevant is that they are being standardized to some degree.
Each state has their own laws and variations on licensing, but when it comes to extraction we follow ASME codes, CGMP codes and other uniform nationwide codes, so we’re not subject to massive regulations changes. There are individual circumstances where municipalities can potentially change individual aspects of what they’re saying, but it’s not increasingly burdensome for us.
Q: Do you ever draw resources or inspiration from other industries, such as pharma lab design, food and beverage lab design, or agriculture lab design?
A: Returning to standardization, it’s not necessarily drawing inspiration but designing to strict manufacturing standards. This comes down to really understanding how products are made and meant to be consumed either as a supplement or as a pharmaceutical drug. That all goes into cleanliness and traceability. If a supplement or drug is entering a person’s bloodstream and that product becomes contaminated, for example, that entire traceability needs to be transparent all the way back to the original trace source. That’s what pharmaceutical or GMP manufacturing is about.
When we talk about drawing inspiration, all of the construct is already there. It’s not a creative design process where we’re making a piece of art; it’s a standardized, traceable, and clean production facility. For example, if the product is derived from a botanical, this ensures that from the moment it’s a seed in the ground to the moment the final compound enters the bloodstream, every single person, machine, and environment that the molecule touched is traceable.
You can see the importance of integrating standardization and traceability into the design, and that’s ultimately what we’re designing the labs for. They’re the same types of standards used in pharma, cleanliness, and food and beverages.
Q: What sorts of challenges have you encountered in this field, and how did you overcome them?
A: Early on, the biggest challenge was a lack of regulation and standardization. While it was nice in that it was a free-for-all where we didn’t have to follow any rules, it also created more uncertainty and risk for the end consumers for all of the reasons I previously described. Ultimately, as additional regulation came in it was challenging in and of itself to meet these new standards and codes. Upgrading everything to pharmaceutical-grade manufacturing or CGMT standards and maintaining it was one of the biggest obstacles that took a lot of work.
The other challenges for us, and which affects manufacturing, cultivation, and retail companies as well, are the taxing and banking issues. There are very few banks that will agree to do business with cannabis companies so we have to resort to specialized credit unions. The infrastructure isn’t there for the cannabis industry as it should be and it puts a damper on it.
So the two biggest challenges, then, would be staying up on and meeting regulations as it pertains to manufacturing standards, and the fiscal banking and monetary standards.
MaryBeth DiDonna is lab design editor for Lab Manager. She can be reached at firstname.lastname@example.org.