Clearing Regulatory Hurdles in an Evolving Market

Contributed By John Giordano, LJ Star

Extraction removes and concentrates the most valuable and beneficial organic compounds from the hemp plant, such as cannabinoids, terpenes, and flavonoids. This process allows for higher purity, more accurate dosing, and stronger and longer-lasting concentrates for use as ingredients in cannabis products ranging from therapeutic to recreational.

Safety is a paramount concern. Extraction is performed with solvents under high pressure and high temperature. Cannabidiol (CBD) manufacturers want to know that the extraction equipment they use will reduce the risk of worker injury and meet government safety standards.

However, governmental approvals and regulatory issues are still being hammered out. They vary from one country to another and even from state to state in the U.S. It takes a seasoned manufacturer to navigate the resulting “Wild West” patchwork of regulatory confusion for a successful market entry.

A good example comes from a manufacturer of closed-loop hydrocarbon extractors. ExtractionTek Stainless was founded in Colorado in 2011 to meet the demand for safe, efficient extraction machines suitable for butane and propane solvents.  Its managers saw an opportunity to enter the Canadian CBD processing market. However, they needed a supplier that would ensure its parts met stringent Canadian safety guidelines.

The search for a secure sanitary clamp

In a CBD extraction system, connections are joined by sanitary clamps that enable the vessels and associated connectors to be easily cleaned. ExtractionTek reached out to clamp supplier LJ Star during its search for an ASME-approved clamp with a high-pressure rating. LJ Star manufactures sanitary clamps that can handle the biggest risk factors related to the extraction process, such as high pressure and thermal cycling. Properly engineered clamps provide a vital safety feature in a process that combines high pressure with flammable liquids and gases.

LJ Star’s ASME Section-VIII rated sanitary clamp adheres to the highest engineering standards to ensure uniform clamping compression for an observation window installed in a high-pressure system. The clamp features a heavy-duty three-bolt and hinge design for safely operating systems, while allowing quick access to joints for cleaning and/or inspection.

Once ExtractionTek evaluated the LJ Star product line, the company decided to add a sight glass window to its extraction vessels, allowing for process observation: visual monitoring of a process without interrupting the process. Operators could evaluate the fill level within the vessel and assess the color and clarity of the liquid.

The journey to obtain proper certification in Canada

ExtractionTek was approached by a Canadian firm that wanted to use its equipment for CBD extraction. However, the country strictly regulates pressure-retaining products and systems. Any high-pressure system operating at greater than 15 PSI must obtain a Canadian Registration Number (CRN) for legal installation and operation. This includes equipment used for cannabis extraction and processing.

The review process is rigorous and detailed. First, CRN requirements demand a 10X safety factor. For example, on a machine that generates 350 PSI, the equipment and fittings need to be able to withstand 3500 PSI to meet these standards. While on occasion, the entire system is reviewed as a whole, at other times, these regulations often apply to individual parts and components. In this case, the clamps for the observation window had to withstand an independent review.

Unlike its competitors, LJ Star already had the CRN clearance, streamlining the process for ExtractionTek to enter the competitive Canadian CBD processing market. Despite this head start, the process still required between six to nine months of extensive and detailed paperwork and processing to obtain the final certification.

LJ Star recommends mechanically prestressed sight glass windows for observation in extraction equipment for the CBD industry. Its windows are formed by a special process involving melting borosilicate glass inside a metal frame, which results in the fusion of glass and metal. Upon cooling, the glass solidifies and the difference in the linear coefficient of thermal expansion between glass and metal produces forces that create a uniform compressive stress throughout the glass. This high degree of mechanically induced compressive stress makes a sight glass having the highest pressure-rating available.

An operator observes the CBD extraction process through a METAGLAS sight glass on an ExtractionTek extraction system.

An industry under pressure

ExtractionTek was approved for its extraction processing system in each Canadian province, thanks to obtaining the CRN. As U.S. states legalize CBD processing, ExtractionTek plans to demonstrate that its systems adhere to regulatory standards that are far more rigorous than any state has so far mandated for quality engineering and safety.

CBD manufacturers should review their local engineering and safety requirements and be certain that their equipment is in compliance. As the industry is quickly growing and still evolving, government officials may not have clear rules established. In such cases, manufacturers can leverage the expertise of their equipment suppliers and supply examples of best practices.