Extraction through Chromatography
This continuous manufacturing solution is an automation system providing automation from high pressure CO2 extraction through chromatography separations. This automated system provides a full containment of extract from extraction through distillation through the chromatography phase.
When using extraktLAB’s pure99 equipment, you will have greater tunable selectivity as defined by the method, including the stationary phase and the mobile phases, and the methods can be changed to change the selectivity – all WITHOUT water in the eluent.
Frequently Asked Questions
How do you remediate psychoactive cannabinoids from CBD oils?
There are several processes for the removal of psychoactive cannabinoids from CBD distillate. These include
1. Precipitation of CBD in a solvent
2. Chromatography separations.
3. Partitioning of cannabinoids in different organic solvents.
4. Degradation of psychoactive cannabinoids with oxidation and light.
In the isolate process, the CBD is precipitated from the oil in a nonpolar solvent blend Leaving the psychoactive cannabinoid in the supernatant to be discarded.
The second process is chromatography. In chromatography, cannabinoids are separated again in a solvent while flowing A packed bed of particles. This process can be frustrating for the end-user because it requires a high level of skill to conduct the separation. Oftentimes the particles can fail and plug up if the sample that is being separated has not been properly prepared. If done correctly, this process has the potential to separate out large amounts of CBD from psychoactive cannabinoids.
The third process involves separation by partitioning between two immiscible solvents. This process is very solvent intensive and is costly from the standpoint of solvent usage. There are also issues with solvent contamination of the final broad spectrum CBD oil. If done correctly, this process has the potential to separate out large amounts of CBD from psychoactive cannabinoids.
Finally, the last process involves degrading the Delta 9 into CBN with oxidation and uv light. The problem with this approach is that the CBD also degrades so the yield for this process is typically less than desirable.
Does distillation replace chromatography?
Chromatography and distillation are not analogous. Chromatography utilizes differences in chemical affinity to separate a mixture of components, distillation utilizes differences in boiling points. Wiped film distillation does not separate THC and CBD despite their differences in boiling points. Chromatography will separate THC and CBD into their pure fractions.
Is Cannabinoid Separation and Chromatography Training Included?
All of our chromatography products come with 2 days of training with optional on-site training at our demo facility in Osceola Wisconsin. Cannabinoid separation methods are also provided. Additional training for HPLC and for headspace GC is typically conducted at our facility in Osceola Wisconsin. On-site training for these items may be purchased by the customer.
What other Equipment is Required for the Pure99 to Function?
Other equipment and infrastructure besides the Pure99 is required to enable the proper functioning of a separations facility. These items include equipment that is either to measure how the method is doing overtime, equipment that is needed to measure how
HPLC with methods
fracTRON to remove solvents
Headspace GC with methods
Chillers and Heaters
Stainless or Glass Mixing Tanks
Drain Droid filtration
C1D2 Compliant Room
Solvent Storage Control Area
Do Methods Come with the Pure99?
Yes. We provide the methods for separation of THC and CBD. If the customer desires to separate out other cannabinoids, they are welcome to develop their own methods.
Are the Chromatography Methods Validated for Cannabinoid Separation?
The customer validates the methods according to their company’s validation protocol. Chromatography and cleaning validation protocol for analytical methods are significantly different than production validation protocol and also very significantly from customer to customer.
Do you provide SOPs for the Chromatography equipment?
Yes. We provide Standard operating procedures for analytical hplc, preparative hplc, GC headspace, and for sample preparation. We also provide start up kits for each one of these pieces of equipment along with sample management software called the igwLAB
What is the throughput of the Pure99?
Chromatography throughput for the specific example of the remediation of 1-3% THC in concentrated CBD can range from 1 kg to 6 kg per hour. Similar to distillation where the throughput will depend on the purity of the sample and how aggressive the cut is made, the throughput of a chromatography system is a trade off between purity of the final product and how aggressive the “cut” is made. It really depends on you. The general rule of thumb is that the sample will be more pure as the throughput decreases.
Can I separate minor cannabinoids from major cannabinoids using the Pure99 Chromatography System?
We provide methods with the Pure99 system for THC and CBD separation. We also produce selective materials for CBN separation from THC/CBD. For other minor cannabinoids, the separation depends on how it will elute from the column in relation to the other major cannabinoids in the sample. That elution time and order depends on the column separation material known as the stationary phase, and the eluent, also known as the mobile phase. Scientists who are experts at finding unique conditions that will meet the goals of the separation are called chromatographers and they do methods development to find a suitable method.
What is cGMP & EUGMP?
Current Good Manufacturing Practices, or cGMP, is a set of standards defined by the FDA that are intended to ensure acceptable manufacturing processes in regulated industries like pharmaceuticals, food and supplement manufacturing.
These standards can apply to: assurance of raw material quality, testing parameters, standard operating procedures, quality management, identifying and investigating deviations, etc. All of these standards intended to mitigate potential risks of contamination, quality failure or any other impact to potential customer safety.
Essentially the same principle, EUGMP standards are set instead by the European Medicines Agency intended to ensure quality and safety of products in the food and pharmaceutical industries.
What Are the Differences Between EUGMP & CGMP?
Though similar, there are a few key differences between cGPM and EUGMP. In both instances, a yearly review of manufacturing practices and product quality is required.
The FDA “Annual Product Review” (APR) is implemented to evaluate the quality standards of each drug product annually and also determines the necessary changes in specifications and operating procedures.
The primary task of the EU ”Product Quality Review” (PQR), however, is to focus primarily on the overall quality and manufacturing system and to show that any manufacturer is consistent in quality control when creating their products.
Why do cGMP and EUGMP Regulations Matter?
From producer to customer, these GMP standards are essential to ensure quality and consumer safety. Without these standards, it would be all too easy for manufacturers to cut or compromise quality practices that are implemented for the end user to receive a good, safe product.
This applies to risk of contamination, mistakes like mislabeling, consistent product contents, etc. Not only could this lead to a product that may be unsafe, it could lead to a product that is essentially ineffective.
Unless you intend to keep your market in your own country, it is important for you to pay attention to (and abide by) both cGMP and EUGMP standards. The CBD industry is often referred to as the wild west because of its rapid legalization without the standardization to match. While that research is being conducted, producers can confidently create a product that is safe and effective for their customers by adhering to these GMP guidelines.
Is This a Federal Law or State Law? Do States Force You To Use it?
Any manufacturer of food or active substances is required by law to adhere to GMP standards.
In the United States, GMP standards are enforced by the FDA. This can be monitored through regular facility inspections that ensure a manufacturer is complying with cGMP standards during production.
Serious violations of those standards, can result in product recall or other serious repercussions that could severely impact the manufacturer in terms of profit loss and operations.
If You are Based in the US and Want to Sell Hemp Products to the EU do You have to be EUGMP Certified?
Yes. While similar, your facility will need certification in both US and EUGMP standards in order to sell any hemp based products from the United States to Europe.
This can be advantageous overall when entering the markets of other countries as the standards of EUGMP are notably high. This allows for the potential access of a multinational European CBD market as opposed to a singularly American market.
Get in touch with our team to request a quote, learn more about our continuous manufacturing automation solutions.
We are dedicated to providing you with the expert advice, quality and service in the industry.
Meet Our CEO and Founder Dr. Jon Thompson, Ph.D
Dr. Thompson is a separations scientist, entrepreneur, and inventor. As a scientist, he has a strong technical background and industry experience in analytical instrumentation, in-vitro diagnostics, biotech, mining, and homeland security markets. During his industry career, Dr. Thompson has earned a strong track record of winning and implementing botanical extractions, formulations, quality, and products in well-regulated, medically-modeled states. Dr. Thompson has assisted numerous companies to attain their goals in hemp manufacturing, as well as market development, strategic marketing, and worldwide business-to-business alliance formation (including international markets).
He received a Bachelor of Science degree in Biochemistry, Master of Science degree in Chemistry and a Doctor of Chemistry degree–all from the University of Minnesota.