Farming, processing and production

To ensure the quality of our products, we maintain control and provide transparency of our entire value chain. CBD for all our products comes from a plant called Cannabis sativa L., which is a legal strain of hemp according to the European Common Catalogue of Varieties of Agricultural Plant Species, in accordance with Article 17 of council directive 2002/53/EC of 13 June 2002.

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The cultivation of Cannabis sativa L.  used in our products is outsourced to Greenvalley, Italy, which specializes in industrial hemp farming. Continuous analyses are performed on our Cannabis sativa L. before the extraction process. All certificates of analysis related to cultivation are recorded and documented in our system and can be found below.

Green Valley has developed a genetic research program that allowed to identify which seeds can be specifically suitable for the production of medical devices. To minimize possible risks to health and environment, cultivation process by Greenvalley does not involve the use of pesticides or any other chemical substances. On top of that, our production follows GACP (Good Agricultural and Collection Practices).

The chemical extraction of CBD consists of separating the needed cannabinoids (i.e. CBD, CBG) from the solid plant matrix, in order to explicitly obtain rich/concentrated extracts of those components of interest, and to remove the THC. The applied extraction methods and conditions are monitored by laboratories, with special attention to process parameters including temperature, extraction agent and reagents used.

Our production 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.

We evaluate every batch of product to secure that it does not contain any traceable THC, as well as that only the CBD from Cannabis sativa L. (legal strain of hemp), is used in treatment line products produced by CS medica. We also ensure to contact relevant Medical Agencies before entering new markets to assure it complies with its current regulation on medical devices and local cannabinoids legislation.

In all processes, high-quality management standards in development, production, and product control are maintained according to HACCP (Hazard Analysis and Critical Control Points). All production phases follow GMP requirements (Good Manufacturing Practice, Rules – Instructions for all phases of the production cycle),and are based on a solid integrated quality system and precise risk management procedures, to ensure compliance with ICH (International Council for Harmonization – Technical Requirements for Medicinal Products for Human Use) stability guidelines, as well as ISO (International Standard Organization) quality regulations (ISO9001, ISO 10993, 14971 and  ISO 13485).

Packaging

The packaging materials that come in contact with our medical devices are evaluated according to ISO 10993. Certificates that related to packaging are documented in our system and recorded in the biological evaluation report of medical device products.

packaging