Production: Cannabinoid Crystals
Each CANNASEN CBD product is based on carefully selected cannabinoids, tailored to the specific treatment purpose
CBD Crystals used in our products are produced from Cannabis according to the European common catalog of varieties of agricultural plant species in accordance with Article 17 of council directive 2002/53/EC of 13 June 2002 with a level of THC below 0.2%.
PRODUCTION OF CANNABINOID CRYSTALS
EXTRACTION PROCESS
To recover extracts from the Cannabis the desired cannabinoids from the plant must be separated
from those cannabinoids that are not needed.
Each specific extract is developed and formulated around a particular cannabinoid. The chemical extraction phase of the right cannabinoids plays a key role in the production process by Enecta which provides us with high-quality cannabinoids.
Chemical extraction consists of separating the needed components (i.e. CBD, CBG) from the solid plant matrix, in order to explicitly obtain rich/concentrated extracts of these components of interest and to remove the THC. Applied extraction methods enhance the properties of our raw material, maintaining the structure and original biological activity of its substances.
The extraction conditions are accurate, standardized, and monitored by laboratories, with special attention to process parameters including temperature, extraction agent, and reagents used. Our process involves the use of GRAS (Class III) solvents like EtOH; and the different procedures ensure the separation of interferents (like wax) that would disturb the purification and isolation phases of a specific cannabinoid, without degrading its natural molecular structure. Such a structured process allows us to work on the acid components (i.e. CBDA) to be decarboxylated if necessary, reducing the formation of secondary process metabolites.
POST PRODUCTION & PHARMACEUTICAL RULES
Each CANNASEN CBD product is based on carefully selected cannabinoids aimed at the specific purpose and product characteristics of the individual CANNASEN CBD products.
In the final CANNASEN CBD products, all cannabinoids extract undergoes a quality assurance check to ensure consistent quality. In the final CANNASEN CBD products, cannabinoids are added as complementing ingredients in order to optimize the overall treatment efficacy of the finished product. In our medical devices, cannabinoids are used as excipients.
All our subcontractors’ production phases follow GMP (Good Manufacturing Practice – Instructions for all phases of the production cycle) which are based on a solid integrated quality system and risk management procedures, ISO (International Organization for Standardization) that is quality regulations ensuring safety and quality precautions for consumers, ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) and HCCAP (hazard analysis and critical control points) which ensure that the quality and safety of our food supplements are appropriate and consistent, and in compliance with safety, quality, and efficiency requirements.
All these quality goals are achieved by using well-qualified staff in all processes and by applying certified procedures with the use of appropriate equipment.
LAB TESTING
ALL CERTIFICATE OF ANALYSIS RELATED TO CBD CRYSTALS
IS RECORDED AND DOCUMENTED IN OUR SYSTEM.
In collaboration with our partners, we thrive to provide our customers the right testing of the CBD crystals for every step in the process. This is essential to ensure that the quality and purity of our products are of high quality.
All declarations document regarding CANNASEN CBD Crystals can be found below
Certification and lab testing
In collaboration with our partner Enecta we thrive to provide our customers the right testing of the CBD crystals for every step in the process. This is essential to ensure that our products quality and purity are of the highst quality. All certificate of analysis related to CBD crystals is recorded and documented in our system.
High Performance Liquid Chromatography (HPLC) and NMR
The crystals used in our products are furthermore evaluated and the composition tested with the use of scientific techniques and technologies, such as HPLC and NMR. Following the CoA from Enecta for every batch, we use the NMR for identification and the HPLC for the quantification of general cannabinoids. In addition, we run a full test on the crystals for microbiological contamination, heavy metals, and pesticides. The example, full certificate of analysis for CBD Crystals for every batch from Enecta can be found in Appendix 5.
GMO Statement (Genetically modified organisms)
Enecta declares that the plant material used to manufacture CBD products do not come from GMO (free from any type of genetic engineering) according to Regulations (CE) No 1829/2003, No 1830/2003 and European Directive 2001/18/EC. The declarations are included in Appendix 7 and 16.
Material Safety Data Sheetprovides informationsuch as hazards identification, composition, physical and chemical properties, toxicological properties of CBD crystals. A detailed description of cannabidiol can be found in Appendix 8. This document does usually not change with different batch number of the products (CBD crystals).
Origin statement
Extraction of the product “Cannabidiol isolate” from selected hemp plants of the authorized varietiesis registered in the common catalogue of varieties of agricultural plant species (Article 17 of Directive 2002/53 / EC of 13 June 2002). The statement of origin can be found in Appendix 17.
No reach registration declaration
The product “Cannabidiol isolate” is not subject to Regulation (EC) no. 1907/2006 of the European
Parliament and of the Council of 18 December 2006 concerning the registration, evaluation, authorization, and restriction of chemicals (REACH). This can be found in Appendix 22.
No test on animals’ declaration
The product “CBD Crystal” has not been subject to animal testing after 2013 in accordance to the
provisions of Art. 18 of Regulation (EC) N. 1223/2009 of the European Parliament and of theCouncil of 30 November 2009 on cosmetic products. This statement can be found in Appendix 23.
STORAGE & DISTRIBUTION
Finished products are transferred to our Warehouse ready to be distributed to our customers.
- Document management
- Management review and monitoring
- Qualification of suppliers and customers
- Complaints
- Incident reports and recalls
- Self-inspection
- Deviations, corrective and preventive actions (CAPA)
- Risk assessment
- Warehousing including reception, storage, and delivery
- Temperature measurement and the like.
- Cleaning
- Equipment calibration
- Transport including handling of temperature fluctuations, operation, maintenance, cleaning, and safety measures of vehicles.
