High Quality CBD
Como é que produzimos o nosso óleo CBD?
A criação de óleo e produtos de CBD de alta qualidade, como os da Enecta, requer competências, procedimentos e equipamento adequados ao objetivo. Nada é deixado ao acaso. Como sabemos que é essencial comprar e consumir com total tranquilidade, parece-nos correto explicar o percurso que leva uma semente de Cannabis Sativa L. a transformar-se em extrato de CBD, pronto para consumo.
Creating a high quality product requires adhesion to some basic principles, principles that are sometimes enclosed within guidelines created by independent bodies.
The fundamental principles that guide our production are:
- Growing in selected fields without using pesticides
- Applying Guidelines on Good Agricultural and Collection Practices (GACP)
- Monitoring contaminants according to the specifications of the European Pharmacopoeia
- Good Manufacturing Practices
GACP and GMP guidelines act as a basis for the establishment of an appropriate Quality Assurance system, providing useful principles to guarantee fixed standards, ensuring:
- That general and specific hygiene requirements are observed (which includes contamination/cross-contamination, personal hygiene and a sanitary production of plant material).
- Control methods
- Documented procedures (SOP) that cover the entire production process in detail
- Safety of the process
- Suitability of the final product.
Meeting GACP and GMP guidelines: enectas Cannabis plants guaranteeing high quality of CBD Products like CBD Oil. This policy helps us ensure, through standardised procedures and by identifying critical production phases (based on the HACCP, Hazard Analysis and Critical Control Points procedures), that the quality and safety of our products is appropriate and consistent, within a complete and up to date internal tracking system (every production lot is trackable and identifiable to the producer and, therefore, to the field and exact place where the plants were grown and harvested).
Our products (in addition to following the GACP guidelines) are certified: Made in Italy, Pesticide Free, Heavy Metal Free (we guarantee the absence of heavy metals through analysis and sampling during the production phases) and Monitored Warehouse (our buildings are constantly cleaned, ventilated and controlled, with specific work areas that are well delimited and suited to protecting products from any kind of potential contamination).
Cultivo
O material de partida para todos os produtos Enecta é a Cannabis Sativa L. Esta planta extraordinária tem muitas variedades diferentes, cada variedade (também chamada "estirpe") tem características peculiares. Desde 2013 que a Enecta investe num programa de investigação genética de sementes para desenvolver plantas de cânhamo especificamente adequadas à produção de canabinóides. Para garantir um óleo CBD perfeito, certificamo-nos de que a semente de Cannabis correcta é semeada, esta é talvez a decisão mais importante que temos de tomar todos os anos.
Preparar o terreno
A preparação do terreno para a sementeira é o ponto de partida e um dos factores fundamentais da fase de produção: um bom campo (em termos de composição, nutrientes e contaminantes) será efetivamente capaz de produzir um bom produto. Por isso, trabalhamos para criar um solo "hospitaleiro" que se torne o habitat natural das raízes, criando condições óptimas de crescimento com um controlo cuidadoso e preciso para evitar o crescimento de ervas daninhas ou a presença de contaminantes.
Semeadura
Plantamos apenas variedades industriais registadas no Catálogo Europeu de Variedades de Espécies de Plantas Agrícolas, em conformidade com a Diretiva 2002/53/CE do Conselho Europeu de 13 de junho de 2002, art. 17, com um nível de THC inferior a 0,2% (sementes corretamente identificadas e certificadas). Todas as informações relativas aos lotes de terra dedicados à cultura do cânhamo são registadas e documentadas, desde a sua localização até às condições de crescimento das plantas, para um acompanhamento contínuo do crescimento da cultura.
Sublinhamos que não utilizamos pesticidas ou outras substâncias químicas, uma vez que não são essenciais para o desenvolvimento e a proteção das culturas. Além disso, graças às análises contínuas efectuadas nos campos, verificamos a qualidade e as eventuais necessidades e/ou deficiências durante a fase vegetativa. Além disso, estas análises representam a base para a amplificação dos canabinóides, o que nos permite avaliar a percentagem de ingredientes activos presentes durante o crescimento das plantas e, consequentemente, decidir qual é o momento certo para a colheita.
Colheita
A colheita é feita através de equipamento agrícola específico que corta as plantas de Cannabis Sativa L. e as desloca diretamente para um reboque ao lado, à medida que as plantas vão sendo lentamente cortadas. Durante esta fase (como em todas as fases do trabalho), damos muita importância à limpeza de todas as máquinas/equipamentos que entram em contacto com o material vegetal, de forma a evitar o risco de contaminação antes, durante e após a colheita.
Secagem
Para obter um produto que cumpra os padrões de qualidade exigidos, o processo de secagem desempenha um papel fundamental para evitar qualquer tipo de degradação, alteração ou contaminação das plantas de Cannabis Sativa L. Depois de colhido, o material vegetal é transportado (em condições secas e limpas) para locais de secagem especificamente dedicados ao processamento do cânhamo. A fase de secagem, sendo um ponto crucial do processamento do cânhamo e, consequentemente, da qualidade do produto final, é cuidadosamente monitorizada, nomeadamente através do controlo contínuo de parâmetros fundamentais como a temperatura e o tempo de secagem, a circulação do ar e a humidade relativa do secador.
Monitoring these three factors represents an operational guarantee to obtain a uniformly dried finished product, prevent potential mould to form and contaminate the whole plant material and allow for correct and adequate preservation over time.
Mechanical separation
Once dried, the material undergoes mechanical separation. This processing phase allows the plant material to be perfectly separated through a machine that works automatically by rubbing brushes and passing through vibrating sifts and fixed sieves. Once the mechanical process is complete, the waste material will be completely separated from the perfectly ground material useful for our purposes (active ingredients extraction) which will be packaged and stored.
Packaging and Storage
Once the separation process is complete, the ground material moves directly from the separating machine to the specific exit mouths, which have bags at their ends (specifically intended for food use, clean and dry, allowing for transpiration but not contact with external substances/possible contaminants) for the final packaging. The machine cycle therefore allows for controlled and continuous filling (reducing the passing and intervention of operators). However, we highlight the fact that all the material used during the different processing phases is registered and comes with technical data sheets attesting to its compatibility and utility for our qualitative aims and objectives.
The packaged material, therefore, is stored on pallets. In this phase the final labelling of homogenous lots occurs, with an individual lot number summarising all processing data, allowing clear and precise product traceability. The pallets are stored in specific well-ventilated areas of the warehouse, with protected accesses, and spaces are easy to clean and subdivided by processing phase. Once the packaging process is complete, the material waits to be shipped to our production site (or to clients).
CBD OIL PRODUCTION
To obtain an extract, the interesting compounds of the plant need to be separated from the ones which have no use for us. More specifically, every Enecta extract is developed and formulated around a specific cannabinoid. Cannabinoids can be separated from the plant matter in many different ways. We have developed specific methods to ensure both safety and efficiency of this process. This is why we can guarantee that the best CBD oil can also be affordable for our clients.
Pharmaceutical guidelines
The packaged and stored hemp is ready to be shipped to our production site (or to clients), where the plant material will undergo further processing to obtain the final product. Our priority is to maintain high quality management standards in the development, production and control of our products, in order to guarantee that they meet safety, quality and efficiency requirements simultaneously.
All production phases follow the GMP requirements (Good Manufacturing Practice, rules and instructions applying to all stages of the production cycle) and are based on a reliable integrated quality system and accurate risk management procedures, to guarantee that the products are in compliance
with the ICH (The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) stability guidelines, the ISO (International Standard Organisation) quality regulations and that they are therefore suitable for the intended use and does not present a risk to the consumer because of inadequate safety or quality precautions.
This quality objective is achieved both through the work of the well-qualified personnel involved in all processing phases, and by using certified procedures on the premises and spaces, with suitable equipment and services.
CBD oil extraction
A key role of production is the chemical extraction phase which happens in laboratories where all operations are planned, checked, recorded and reported. Chemical extraction consists in separating the interesting components (i.e. CBD, CBG) from the solid plant matrix, so as to only obtain rich/concentrated extracts of these components of interest, with an accurate removal of THC. The applied extraction methods enhance the properties of our raw material, maintaining the structure and original biological activity of its substances.
The extraction conditions are accurately standardised, 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; the different following steps ensure the separation of interferents (like wax) that would disturb the purification and isolation phases of a specific Cannabinoid, which should happen 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.
Quality control
Quality control approves and implements allquality control procedures: putting in writing the detailed procedures forsampling and in- and post-process testing; keepingproduction documentation and records; defining the cleaning and sanitising procedures of the premises; checking operating conditions (calibration and maintenance) of tools, machinery and equipment; monitoring process efficiency; guaranteeing correct container labelling andpackaging conformity; monitoringproduct stability; implementing effective traceability systems. Quality control is therefore not limited to laboratory operations as it is involved in all decisions regarding the quality of the product (from growing the raw material to packaging and distributing the final product).
Post-production
As for product packaging, it can be divided into different categories, based on the purpose and the role in the production chain. By “packaging” we mean the enclosing material intended to contain the products and ensure their protection, presentation and allow them to be handled safely from producer to consumer.
In general, packaging can be divided into primary and secondary. The first category refers to containers directly in contact with the product (i.e. vials, bottles), while the second categoryconsists in the packaging enclosing the primary material (i.e. cases for small bottles etc).
The purpose of quality packaging, that is, what is asked to ensure the consumer is:
- Perfectly adapted to the product,ing protect its integrity and preventing any potential penetration from external agents;
- Effective resistance to external environmental conditions (particularly for primary packaging, which should be light-resistant and airtight);
- Adequate product protection with precise characteristics to guarantee the integrity of the product during movement or transportation;
- Correct communication on the nature of the contents.
The products, in fact, can deteriorate due to chemical incompatibility between formulation components or with packaging materials, or even the effects of humidity, oxygen, light and various temperatures. For example, using opaque containers (made of metals, coloured plastic or amber glass) allows you to protect the product from light and oxidation reactions. The packaging will contain the product lot number for traceability and to have the necessary information to identify the product (name, qualitative and quantitative composition, expiry date), allowing its authenticity to be traced. The traceability is a process that follows the product from upstream to downstream in the production chain and ensures that, at every stage, appropriate traces (information) are present and included in the creation of the lot number.
Storage and distribution
The places dedicated toproduct storageare designed to: ensure good storage conditions; allow the orderly and categorised storage of goods andreduce the risk of contaminationto a minimum; overall, to prevent any negative effect on thequalityof the products; to maintainadequate storage conditions(light, temperature, humidity etc.) and therefore, to keep the quality and integrity standards constant during both storage and transportation.