Hemp Extracts

CBD Manufacturing from Hemp

CBD (Cannabidiol) is a high value product which can be manufactured from hemp, varieties of cannabis containing <0.3% THC.

The CBD Manufacturing process contains many steps from seed to sale. Because CBD is intended for use as a medicine, or a food supplement, it is essential that both hemp cultivation and CBD extraction and manufacture follow Good Manufacturing Practice – the standards that ensure safe production of food and drugs.

CBD Manufacturing Process

Hemp CBD Manufacturing overview

The manufacturing process for cannabis derived medicines such as CBD is multi-step and requires several different stages, each with a separate set of equipment.  In total, the process takes many months from growing the plant through to extracting and refining the CBD before sale or incorporation into finished medicines.

Because CBD manufacture uses an herbal raw material – hemp, there are often inconsistencies between batches which require troubleshooting and small adjustments to the process.   High quality manufacturers invest the time and resources necessary to ensure a consistent product. This includes developing a reliable supply chain to ensure that the extracted material are of high quality and consistency.

The following outline is representative of CBD manufacture for medicinal use.
High CBD Hemp Material Incoming and Receiving

Cultivation of high CBD, low THC hemp (Cannabis Sativa) flower is done in an separate facility (or a distinct, separated part of the same manufacturing facility) dedicated to growing, trimming, and drying the material.  Once it reaches the doors of the processing and manufacturing facility it is considered a “raw material”.

High CBD Hemp is most often cultivated outdoors on speciality farms (medical hemp cultivation). In some situations, hemp is also cultivated in greenhouses or indoors. Alternatively, industrial hemp biomass may be used which typically has lower levels of CBD and higher risks of contaminants. This material is not ideal for medicinal manufacture but may be suitable for isolate manufacture.

Upon arriving at the facility all raw materials go through Incoming and Receiving testing and inspection to ensure they are pure and fit for use in the manufacture of medicine.  

Incoming and Receiving testing is not unique to incoming hemp raw material.  This type of testing and inspection is also conducted on any materials, components, or packaging which will be used in the manufacture of finished product.

Examples of materials which are tested and inspected during Incoming and Receiving testing include:

  • Bottles, droppers, and caps.
  • Vape pens, chargers, batteries, and tanks.
  • Labels and cartons.
  • Ingredients and excipients.
  • Processing chemicals.

Due to the potential variability, heterogeneity or inconsistency of incoming hemp flower and related products, a standardized process for sampling for dried herbal product is followed to ensure representative sampling, inspection and testing to ensure they are suitable for use.

Grinding Hemp Flower for Extraction

Grinding is the process of taking hemp raw material and breaking it down into smaller particles.  This increases the surface area of the hemp flower, making it easier and more efficient when extracting the CBD and other cannabinoids.

CBD Hemp Oil Extraction

Extraction is conducted using an extraction machine such as an ethanol or COextractor.  At high pressures, COacts as a solvent (similar to hydrocarbon liquids) instead of an inert gas, allowing it to pass through the raw material and selectively dissolve target compounds. After extraction the COsublimates at normal atmospheric pressure thus producing a clean extract which does not have residual solvents.  The ground raw material is packed into COextraction vessels rated to the pressures involved.

When extraction is complete, a series of fractioned cannabinoid and terpene extracts will be ready for further processing.  The extracts contain all of the necessary active ingredients that will be used in the final products. At this stage the extract requires refinement before it is bioavailable as a medicine or finished product. At this stage in processing the extract is referred to as raw crude.

Hemp Oil Dewaxing

Raw crude from the extraction process contains waxes, plant pigments and other impurities which are removed in a process called dewaxing. To begin this process a food grade solvent such as ethanol is added to the raw crude which facilitates the precipitation of undesired waxes present due to the solubility selectivity determined at extraction.  Removal of these waxes will increase purity and concentration of cannabinoids.

Upon chilling in a freezer, waxes begin to precipitate and dewaxing is performed via filtration.

By breaking bonds of fatty plant matter, the separation and removal of waxes from the wintered material is conducted.  Dewaxing stabilizes the cannabinoid solution, preparing for successful formulation.

Dewaxing purifies the cannabinoid solution, allowing for a more potent final oil.  For successful dewaxing, the polar substances within the solution must be separated from the non-polar.  

The bi-product of dewaxing is a hemp wax.  This wax contains little to no cannabinoids. In some applications, the wax may be saved for use in products.  In most applications, the wax is destroyed.

Time, temperature, and the amount of waxes present will determine the efficiency of wax removal. The ultimate goal of dewaxing is always to eliminate all waxes from the solution.  The less waxes that are present, the more stable and potent the final oil will be.

With heavy loads, this will require multiple stages of dewaxing and filtration with intervals sufficient to allow precipitation of waxes.

Hemp Oil Filtration

Once waxes have been successfully separated and the wintered material has reached the temperature target, the solution will be filtered.  Filtration is the final step in dewaxing.

During dewaxing, the non-active components of the solution are separated.  Cannabinoids are kept suspended in the solvent due to temperature and mixing procedures.  

By filtering the wintered solution the waxes may be removed, leaving the cannabinoids dissolved within the solvent.

To perform filtration, the supernatant is transferred to a clean vessel through a food grade filtration system.  The type of filtration used is dependant on the workability of the current solution, and is determined by an experienced Processing Technician.

Types of filtration include gravity filtration, vacuum filtration, pour-through filtration, and wintered filtration.   The goal of filtration is for the properly chilled and prepared solution to pass through porous media to 0.2µm threshold without remaining waxes.

After sufficient intervals to stabilize the temperature, a sample will be drawn and evaluated for any remaining waxes.  Dewaxing success is dependant on experience of Processing Technician and the available equipment. Filtration will continue through several cycles until testing proves the process has reached maximum success.  

Use of a centrifuge will greatly increase success of filtration.   Filtration can take anywhere from 48 hours to 5 days, depending on skill of Processing Technician and available equipment.  

Solvent Removal

Following filtration of waxes, pure cannabinoids remain suspended in the food grade solvent added during the Dissolving phase.  The solvent added to facilitate dewaxing now needs to be removed.

Removal of the solvent is performed using careful vacuum and temperature control optimized to limit any degradation of the target cannabinoid compounds.  Cannabinoids are extremely sensitive to heat, and incorrect temperature control will destroy the purity and strength of the extract.

The most often used instrument for solvent removal is a rotary evaporator.  The rotary evaporator must be furnished with the correct accessories to properly conduct solvent removal with cannabis.   These accessories include things like a vacuum pump, a bulb specified to the proper size and material, and heating bath solvent capable of meeting necessary heat settings.

The rotary evaporator will be set to carefully chosen specifications to pull off the solvent, while protecting cannabinoids and increasing purity of the final material.

When done correctly, the solvent will be recovered at a purity of 90% or greater.  In these cases, the solvent may be re-used for future processes, saving the company large amounts of money and saving storage space.

Storage and recovery of solvents is often a major part of the labor, cost and floorspace allocated to extraction and refinement processes for hemp oil, and is a common reason why companies choose CO2 extraction over ethanol extraction due to the massive volumes of ethanol which must be recovered and stored, which represent an explosion risk.

CBD Distillation

Regardless of care taken during previous steps of hemp processing to extract CBD oil, impurities are inevitable and non-preventable, even by the most skilled techican.  To create the purest extract possible, a final distillation is completed which, when properly conducted, serves many important purposes including:

  • Removal of impurities.
  • Isolation of terpenes, a vital component to formulation of effective cannabis medicine.
  • Decarboxylation of cannabinoids for oral bioavailability.
  • Concentration and purification of cannabinoids – predominantly CBD but also THC and minor cannabinoids such as CBG, CBC, CBN and others.

Short Path Distillation is the single most important and yet precarious of all the purification steps.  Short Path Distillation should only be conducted by an experienced Processing Technician. Conducting Short Path Distillation without proper training and experience can lead to destruction of terpenes and cannabinoids.  

During Short Path Distillation, a combination of temperature, circulation, and vacuum manipulation are used to isolate and separate different cannabis component extracts.

A Short Path Distillation system is usually built piece-by-piece for optimal functionality.  

Proper use of Short Path Distillation can yield anywhere from 70% cannabinoids to 95%, depending on the material, the equipment, and the technician expertise.   The material which results from Short Path Distillation is called “CBD distillate”.

CBD Isolation

Hemp Derived CBD Isolate is purified 99.5%+ CBD and appears as white a crystal, powder or granules. Isolation of cannabidiol is a multistep technical process requiring specialised equipment and experienced staff.

Most CBD isolate is produced using a combination of distillation and chromatography to produce a high purity liquid (80%+ to 90%). At this purity, CBD crystallises spontaneously to form crystals of almost pure CBD. To separate these from the oil they are often precipitated out of solution from a solvent such as pentane or supercritical CO2.

Because chromatography and solvent precipitation both rely on complex solvent mixtures and recovery, and may require multiple passes in order to achieve high levels of purification (99.5% to 99.9%).

Formulation

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:

  • Capsules.
  • Oils.
  • Extract syringes.
  • Vape cartridges.
  • Edibles.
  • And many more.

Calculations are conducted to determine how much extract will be required to reach the target medicinal potency of cannabinoids per dose.  

For example, an oral oil may be formulated by dissolving cannabinoid extract into olive oil.  Terpenes may be added to adjust for flavor. These additions will need to be calculated, and potency tests conducted to ensure the formulation is on target.   

Packaging and Labeling

Packaging and labeling is conducted so that the final formulated material may be marketed for consumer sale and/or use.  

Packaging and labeling tasks include:

  • Bottling or filling.
  • Placing caps or droppers.
  • Labeling.
  • Cartoning.
  • Assembling patient use packets.
  • And much more.

All packaging materials used must be of food grade materials to be considered fit for use.  Labels and cartons will go through several departments for edit to ensure the company message is properly communicated and that there are no illegal drug claims made.

The packaging and labeling process is considered a production step and must be treated as any other step, with tight quality assurance controls in place.  

Finished Product Testing

Prior to reaching market, all finished products must undergo testing to ensure quality standards are met.

The testing will always meet, at minimum, the requirements of local and federal government regulations for safe manufacturing of hemp products.   These tests often include:

  • Potency.
  • Microbiological activity (yeast, mold, bacteria).
  • Water activity.
  • Pesticide residue.
  • Heavy metals.
  • And more.

All finished products must be held in QUARANTINE until test results are returned.  Test results must pass in order for products to be released for retail sale.

Some tests will have specifications set forth by the local government, such as a plus or minus 5 percent (+/-5%) of target potency test.  Other tests will have specifications set by the company which use internal specifications to ensure product uniformity.

Warehousing

All materials, components, in-process material, and finished products must be stored in environmentally controlled conditions.  This is to protect the integrity of the materials and to promote a consistent product.

Cannabis raw material or materials which contain cannabis will be kept in controlled areas for protection from theft, either inside production spaces or in other locked areas.  

Materials which require refrigeration will be kept in environmentally monitored refrigerators.  

Warehouse inventory must be tracked to ensure materials are properly allocated during production.  By carefully and methodically managing warehousing, all components of finished product may be traced from seed, or source, to shelf. For outdoor hemp farms this level of tracking is not presently available, but is common in indoor hemp farms – and will likely be a key part of medical cannabis quality standards for pharmaceutical or ethically produced product lines.

Distribution

Final products must be held and distributed according to GDP, or Good Distribution Practices.  These guidelines are designed to ensure the correct materials reach the intended final user or distributor.

First in first out (FIFO) principals will be utilized which guarantees stock is properly rotated. This keeps product fresh and ensures materials do not expire while on the warehouse shelves.    FIFO practices also ease in inventory, as there is only one active lot/batch of material in use at any time.

All distribution history must be carefully documented, including what specific batch numbers of each product the customers are receiving.  This information is required so that in the case of a recall, all product can be traced to the final end user and pulled from shelves.

Good Distribution Practices are the final step in achieving a full seed-to-shelf traceability system.

Conclusion

The production process for manufacturing cannabis medicine in a GMP environment is made up of many distinct steps.  Each phase of the production lifecycle is as important as the others in bringing a clean, pure, and quality product to market.

Our staff is experienced in running a GMP manufacturing operation, and is skilled in training client personnel to independently operate the facility.   We are a chosen partner in the international market because of our dedication to quality, and the success of our throughput.

We are able to source, qualify, and install all the equipment necessary to conduct the steps mentioned throughout this document.  Each facility will be designed to manage the projected throughput of flower, and the specific goals of the client.

We are ready to help your company build and operate a successful production facility using our proven GMP methods in manufacturing effective and pure cannabis medicine.  

PRODUCTS
Hemp Extracted Isolates (CBD & CBG):
We offer volume discounts on bulk quantities of our products. Pricing
for bulk quantities of our product line is determined by the volume of products
ordered. Products usually ship within 24-72 hours of receiving funds, but please
allow for up to 5 business days for shipping. An accurate shipping time-frame will be
included on every invoice along with wiring instructions.
Hemp Extracted 0% THC Distillate
This product averages around 88% CBD and up to 90% total cannabinoids. A
certificate of analysis (COA) is issued with each batch. Pricing detailed below. We
can customize the product and go down to around 50% CBD if desired and can go up
to .3% THC, if buyer desires. Usually ships within 24-72 hours of receiving funds, but
please allow for up to 5 business day for shipping. $20 per container for glass pyrex
containers. An accurate shipping timeframe will be included on every invoice along
with wiring instructions.
Hemp Extracted Distillate
This product averages around 75% CBD and up to 90% total cannabinoids. We can source a
flowable and stable honey colored 50-60% CBD Distillate for vape lines if needed. A COA
issued with each batch. We provide several purchasing options and offer volume discounts
with pricing detailed below. This product usually ships within 24-72 hours of receiving
funds, but please allow for up to 5 business days for shipping. $20 per container for glass
pyrex containers. An accurate shipping timeframe will be included on every invoice along with wiring instructions.

PRODUCT DESCRIPTIONS

CBD WATER MISCIBLE POWDER
300 mg CBD Per 1 gram gross weight 
Water Miscible CBD Powder is a phytocannabinoid rich powder with 29.1% CBD, and
no other minor phytocannabinoids or terpenes. This formulation has been designed for maximum
uptake and bio-availability. The pure white powder has little to no taste or after taste, and as an
isolate water soluble formulation, when mixed with liquids, only a slight color change or fogginess
may occur. Ideal for semi-solid or solid products, including but not limited to beverages, pet treats,
capsules, edible products and most ingestibles. Approximately 29.1 mg of active CBD per 100 mg of
gross weight. This product contains pure 99% CBD Isolate, Starch, Polysorbate 80, Cellulose &
Calcium Phosphate. 0% THC product.

4.20% CBD Water Concentrate (CBD Isolate Based)
1 Drop = 2 mg CBD +/-
4-5% CBD Beverage Additive is extremely effective with 1 drop = 2.5 mg of active CBD.
A built in lid dropper makes it simple to dispense the desired amount of drops. Just add some drops
into your water, coffee, or any other beverage and enjoy! This additive has a very high bioavailability
due to its purity and water miscible formulation, making it one of our best sellers. This is a 0% THC
product (0.01% THC is in concentrate, which will be diluted when added to a beverage). Ingredients:
Activated CBD isolate, capris/caprilic triglycerides, polysorbate 80, calcium phosphate.

REST & ENERGY - Full Spectrum Beverage Concentrate
1 Drop = 1 mg CBD +/-
2.5% Full Spectrum Beverage Additive is very effective with 1 drop = 1.25 mg of active
cannabinoids. A built in lid dropper makes it simple to dispense the desired amount of drops. Drops
can be added into your water, coffee, or any other beverage. This additive also has a very high
bioavailability due to its purity and water miscible formulation. Ingredients: Hemp extracted
distillate, capris/caprilic triglycerides, polysorbate 80, calcium phosphate.

HEMP-DERIVED CBD PROFIT BY THE NUMBERS

Using the latest Nevada hemp announcement from CROP Infrastructure Corp. (OTC: CRXPF) (CSE: CROP), one can start to see the potential for CBD by the numbers.

The previously announced 240 acres of CBD Hemp was planted and is currently 1.5 feet tall and growing under pivot. All harvesting equipment has been secured for the resulting hemp biomass. It is estimated that the 240 acre pivots will yield 240,000 pounds of hemp flower.

Typically, the grower can yield two harvests per year, bringing the potential on just the original 240-acre harvests to 480,000 pounds of hemp flower—or 217,724kg.

Many of today’s popular US hemp strains can reach levels of 15-20% CBD, and CROP’s genetic analysis already pegged its hemp’s CBD content at greater than 15%.

Today’s market price for hemp is between $20-$50 per pound of dried flower, depending on CBD content and quality. However, real money is in high-purity CBD isolate. Therefore, the concentration to turn 15% flower into a +99.0% CBD isolate is 100/15, or 6.67 to 1— +~10% for any recovery loss or 7.337.

If one takes the 217,724kg that could be derived from the 240 acres in rotation already, that biomass could be concentrated down to 29,674kg of CBD isolate.

Now, here’s where the value resides. What exactly is the wholesale price of CBD isolate?

According two recent releases of a pair of CROP’s CBD competitors, that price is somewhere between US$5,000 and US$6,500 per kilogram of CBD isolate.

Keep in mind also that CROP just boosted their footprint to over 1000 acres, and has a current market cap of only US$21 million.

As per CROP’s news release, the cost of production is not expected to exceed $700,000 with many of the costs already incurred, and the first harvest is expected in early Q4 this year. The operation isn’t going to cost them an arm and a leg. The key is in fully developing out the state-of-the-art extraction facility that Director and CEO Michael York states is the next phase of development.

Moving forward, the goal is to secure the upgrading of value of the 15% CBD hemp, to that of the +99.0% CBD isolate—or in the case of the 480,000lbs per year on the 240 acres currently being grown, moving the value well beyond $22 million per year.

By these numbers, the value of extraction cannot be understated.


Hemp-extracts is owned and operated by The CBD Store since Dec 20, 2013
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Contact Scott Salisbury Info@hempextracts.co 
253 221 9051 Cell Phone. Seattle WA. Call anytime