Manufacturing CBD from Hemp
The manufacturing CBD from hemp involves the processing of the hemp from processing and extraction to isolation and production of the final products that contain CBD. High-quality CBD products are manufactured from hemp and ingredients derived from hemp (e.g. CBD Isolate or CBD Distillate, CBD Oil).
In ensuring that high-quality CBD products are manufactured, the CBD (Cannabidiol) and other active ingredients that are used in the final products must be produced to a specific standard. It is required that the manufacturing process of CBD oil and other ingredients which can be gotten from hemp, and any cannabis variety that contains <0.3%THC.
There are many steps involved in the CBD manufacturing process from the seed (or clone) to when it is sold. It is very important that the cultivation of hemp, and the extraction and manufacture of CBD comply with the GMP CBO Manufacture (Good Manufacture Practice) – the standards that ensure safe production of food and drugs.
The Process of Manufacturing CBD
To produce CBD which can be used in foods or medicine, it is required that hemp is harvested, dried, processed, extracted, refined and purified with special equipment and processes.
The steps used in manufacturing CBD from cultivation to CBD isolation include:
Cultivar selection – High CBD Hemp Cultivars
Cultivation – The cultivation of High CBD Medical Hemp
Processing – Hemp Post Harvest Processing
Selecting Quality Extraction Material – The processing CBD from Hemp
Extraction – Extraction of CBD Hemp
Refinement – Manufacture of CBD from Hemp
Isolation – Isolation of CBD from Hemp
Hemp CBD Manufacturing Overview
The process of manufacturing products derived from cannabis such as CBD involves many steps and different stages, with each step and stage requiring a different set of equipment. Overall, it can take some patience to make CBD which can be sold or added to other finished medicines from the cultivation of the hemp through the extraction to the refining of the CBD. There are usually inconsistencies in batches that require correction and adjustments to the process because it is herbal raw material that is used in the manufacture of CBD. It is this reason high-quality manufacturers spend a lot of time and resources to ensure that they produce a consistent product. This includes developing a strong production network that ensures that the extracted materials are consistent and are of high-quality. HEMPPROCESSING employ the services of quality control, microbiology, chemistry, and production management professionals who have a good knowledge of and experience in the botanical, cannabis and pharmaceutical manufacturing industries. These experts are dynamic in their approach as they bring the best methods in the production of hemp products to achieve a consistent and desired quality. It has been proven over time that it’s not only equipment and the right processes that bring a successful result, but the experience in the equipment and process. Below is an outline which shows how CBD is produced for medicinal use.
High CBD Hemp Material Incoming and Receiving
The growing of a high CBD with low THC hemp flower is carried out in a different location (or a different, separated part of the same manufacturing facility) that is specifically assigned for the growing, trimming, and drying of the cannabis. It is regarded as a ‘raw material” immediately it gets to the doors of the processing and manufacturing facility.
High yield CBD hemp is usually cultivated in the open in special farms to get high yield CBD hemp flowers, or healthy plants with high CBD hemp biomass. Sometimes, hemp can also be grown in greenhouses or indoors. On the other hand, industrial hemp biomass can be used, but it usually has lower levels of CBD and its easily prone to contamination. This is sometimes not suitable for medicinal production; however, it is good for manufacturing isolates.
When it gets to the facility, all materials are subjected to incoming and receiving test and inspected to make sure that they are pure and ideal for the production of medicine.
Incoming and Receiving testing is not done on incoming hemp raw material only. Any material, components, or packaging which is used in the production of the finished product is subjected to these tests and inspection.
Some of the materials which are usually tested and inspected during Incoming and Receiving tests include:
Droppers, caps, and bottles.
Chargers, vape pens, tanks, and batteries.
Cartons and labels.
Ingredients and excipients.
A representative sampling, inspection and testing of dried herbal products is done to make sure that they are fit for use, a standard process of sampling is followed because of the potential variability, inconsistency or heterogeneity of incoming hemp flower.
Grinding Hemp Flower for Extraction
Grinding in the process of breaking hemp raw materials into smaller particles. This is done to increase the surface area of hemp flower to make the extraction of CBD and other cannabinoids easier and efficient.
CBD Hemp Oil Extraction
The extraction of CBD hemp oil is carried out with an extraction machine (CO2 or ethanol extractor). CO2 or ethanol functions as a solvent at specific pressures or temperatures, thereby allowing it to go through the raw material and specifically dissolve target compounds. The solvent is purified after extraction at normal atmospheric pressure, thereby producing an extract that is clean and free of residual solvents. The raw materials are transferred into specialized extraction vessels that are marked according to the pressures and temperatures involved.
On the completion of the extraction, several fractioned cannabinoid and terpene extracts are further processed. All the active ingredients that are required for the production of the final products are contained in the extracts. It is required that the extract (crude) is refined at this stage before it can be used as a medicine or finished product. The extract is still regarded as raw crude at this stage of processing.
Hemp Oil Dewaxing
If needed, a process called dewaxing is used to remove plant pigments, waxes and other impurities which are present in the raw crude from the extraction process. A food-grade solvent such as ethanol is used to start this process by adding it to the raw crude which helps in precipitating the unwanted waxes present in raw crude because of the solubility selectivity at the stage of extraction. Dewaxing is done to increase the cannabinoids purity and concentration.
When it is cooled in a freezer, the waxes are discharged and dewaxing is done through filtration.
The separation and removal of waxes from the raw crude are carried out to break the bonds of fatty plant matter. It balances the cannabinoid solution to ensure a lucrative yield is achieved.
Dewaxing helps in the purification of cannabinoid solution, which allows for the production of a more potent final product. To ensure that dewaxing is successful, it is required that the polar substances in the solution are separated from the non-polar substances.
Hemp wax is a byproduct of dewaxing, It contains little to no cannabinoids. It may be used in the production of other products. However, the wax is destroyed in most cases.
The factors which determine the efficiency of wax removal include temperature, time, and the amount of wax present. The lesser the amount of wax present, the more potent and stable the final product will be.
If there is a heavy load of impurities in the raw crude, it will require several dewaxing process and filtration.
Hemp Oil Filtration
Immediately, the wax has been completely removed, and the wintered material reached the target temperature, the solution is filtered.
The non-active constituents of the solution are removed during dewaxing. The cannabinoids are kept floating in the solvent because of mixing procedures and temperature.
The waxes may be removed by filtering the wintered solution to, thereby making the cannabinoids to dissolved in the solution.
This supernatant is transferred to a clean container using a food-grade filtration system to carry out filtration. The filtration method used is based on the workability of the present solution which is determined by an expert Processing Technician.
The different types of filtration include vacuum filtration gravity filtration, wintered filtration, and pour-through filtration. The purpose of filtration is to enable the chilled and prepared solution to go through a porous media to 0.2µm threshold without leaving wax behind.
Stabilizing the temperature at sufficient intervals, a sample is taken and checked for any wax leftover. The success of dewaxing is based on the expertise of the processing technician and the equipment that is used or available. Filtration will be repeated until it is certain that the process has achieved the maximum result.
Centrifuge is used to increase the success rate of filtration. Filtration can take as long 5 days in some cases, depending on the available equipment and the expertise of the Processing Technician
After the filtration of waxes, pure cannabinoids would still be suspended in the food-grade solvent used during the dissolving stage. The solvent is added to help in dewaxing need to be removed at this stage.
The solvent is removed using optimized temperature control and vacuum to control the breakdown of the target cannabinoid compounds. Cannabinoids are highly sensitive to heat and wrong temperature control can damage the potency and purity of the extract. The instrument that is mostly used for the removal of the solvent is the rotary evaporator. It is Important that the rotary evaporator is equipped with the right accessories to enable it carry out the removal of solvent from cannabis properly. The accessories include a bulb specified to the proper material and size, a vacuum pump, and a heating bath solvent that can withstand high heat settings.
The rotary evaporator is carefully set to a selected specification to remove the solvent, while ensuring the protection of the cannabinoid and enhancing the final product purity.
The solvent can be recovered at a level of 90+% and even greater if properly done. When this is achieved, the solvent can be reused in the future, thereby reducing the company expenses and saving storage space.
Recovery and storage of solvents is usually a major component of the cost, labor, and floor space assigned for the extraction and refining process of hemp products.
The presence of impurities in CBD oil extracts are unavoidable no matter the amount of care taken in the previous stages of hemp processing even by the most experienced technician. To produce the purest extract possible, a final distillation is carried out which serves many purposes when properly done. The purposes include:
Terpenes isolation, an important component in the production of cannabis medicine
Cannabinoid purification and concentration – mostly CBD but includes THC and other cannabinoids such as CBC, CBG, CBN among others.
The most important but dangerous of all the purification phases is the Short Path Distillation. This step should only be carried out by an expert Processing Technician. If this process is conducted without proper training and experience, it will cause the damage of the terpenes and cannabinoids.
A combination of circulation, temperature and vacuum regulation is used during Short Path Distillation. This process is used to isolate and separate different cannabis constituent extracts.
To ensure the optimum functionality of the Short Path Distillation system, it is assembled piece-by-piece. HEMPPROCESSING is an expert in distillation systems, and sources for and assembles Short Path components which are ideal for the projected rate of production of the facility.
Proper utilization of Short Path Distillation can produce about 70% to 95% of cannabinoids, depending on the equipment, material, and the expertise of the technician. The product that is gotten from Short Path distillation is referred to as “CBD distillate.
CBD Isolate derived from hemp is 99.5+% pure CBD, and it appears as a powder or granules, or white crystal. Isolation of Cannabinoid is a technical process that involves several steps which require special equipment and experienced staff.
Most CBD isolate is manufactured by combining chromatography and distillation to produce a liquid of high purity (between 80% to 90%). At this purity level, CBD spontaneously crystallizes to form crystals of CBD that is almost pure. These crystals are usually separated from the oil by precipitating out of the solution from a solvent, e.g. supercritical CO2 or pentane. This is so because solvent precipitation and chromatography rely on the mixture and recovery of complex solvents, and may need to several passes for the achievement of high levels purification (99.5 to 99.9%)
Formulation is the stage where cannabis extract (isolate or distillate, oil) is incorporated into various food-grade carriers and excipients to produce a final product. Formulation is where cannabis extract (oil, distillate or isolate) is mixed into different food-grade carriers and excipients to form a final product. Final product forms include:
To determine the amount of extract that is needed to get the target medicinal potency of cannabinoid per dose, dosage calculations are made.
For instance, an oral oil may be produced by dissolving extract of cannabinoid into olive oil. To adjust the flavor, terpene may be introduced. It is required that these additions are calculated, and potency tests carried out to ensure that the formulation targets are achieved.
Packaging and Labeling
In order for the final product produced to be marketed for consumer use and/or sale, packaging and labeling must be done.
The tasks involved in packaging and labeling include:
Filling or bottling
Placing droppers or caps
Packaging into cartons
Assembling patient use packets, etc.
For packaging to be considered suitable for use, it must be of food-grade materials. Cartons and labels usually pass through various departments for editing to make sure that the company’s message is communicated properly, and there are no misleading or illegal drug claims made.
Because the process of packaging and labeling is regarded as a step in the production, it has to be handled like any other step with strict quality assurance controls in place.
Finished Product Testing
Before all finished products get to the market, they must be subjected to tests to ensure that quality standards are met. It is required that the testing meets the requirements of local and federal regulations for the safe production of hemp products. The tests often conducted include:
Microbiological activity (yeast, mold, bacteria).
Heavy metals, etc.
All final products should be quarantined until the test results are returned. Test results must pass before the products are released into the market for retail sale.
Some tests will have standards set forth by the local government, such as a plus or minus 5 percent (+/-5%) of target potency test. Other tests will have standards set by the company which use internal standards to ensure uniformity of product.
All components, materials, in-process materials, and finished products must be environmentally controlled conditions. This is to make sure that the integrity of the materials is protected and promote a consistent product.
To protect cannabis raw material or materials which contain cannabis from theft, whether in production spaces or any other areas, it should be kept in controlled areas.
Materials which need to be kept in refrigerators should be kept in environmentally monitored refrigerators.
Warehouse inventory must be monitored to make sure that materials are properly assigned during production. All components or constituents of the finished product may be traced from seed, or source to shelf if warehousing is properly and methodically managed. This level of monitoring can be difficult to achieve in outdoor hemp farms, but is available in indoor hemp farms – and will likely form an important component of medical cannabis quality standards for pharmaceutical or ethically produced related products.
It is required that all final products are stored and distributed according to GDP (Good Distribution Practices). These guidelines are developed to make sure that the materials or products get to the intended final consumer or distributor.
First in first out (FIFO) principle is used to ensure that stock is properly rotated. This ensures that products are fresh and prevent the expiration of the materials while on the warehouse shelves. FIFO practices also help in inventory, as it is only one active batch/lot of material in use at any time.
All distribution history must be documented properly, including the exact batch numbers of each product that the customers are receiving. This information is required so that all products can be traced to the final consumer and removed from shelves in case there is a recall.
Good Distribution Practices is the final step in achieving a full seed-to-shelf traceability system.
The manufacturing process of cannabinoid medicine in a GMP environment is made up of several different stages. Each stage of the production cycle is as important as the others in ensuring that a clean and pure product of high-quality is delivered to the market.
HEMPPROCESSING is committed to helping each client in manufacturing CBD from cultivation to processing and product development. It is the mission of HEMPPROCESSING to deliver safe cannabis products to the general public by helping cultivators and manufacturers.
Our staff is experienced in managing the operations of a GMP hemp manufacturing facility and is skilled in training equipping personnel. We are a chosen partner in the hemp market because of our commitment to quality.
We source, qualify, and install all the equipment which are required for carrying out the steps mentioned throughout this document.
Each facility will be designed and developed to manage the projected production rate of flower and the specific goals of each client.
We are ready and willing to help your company build and operate a successful CBD production facility using our proven GMP methods in producing effective and pure cannabis products.