A clean room classification refers to how clean the air is in a clean room environment. Different clean rooms have different requirements to ensure that the required level of clean air is always maintained .
Clean rooms are commonly associated with industries, where the sterility of the environment and prevention of cross-contamination are paramount.
After changes in legislation around Cannabis growth in South Africa, there has been an increase in the demand for Cannabidiol (CBD), oil manufacturing facilities in the country.
Because this medicinal oil is produced for human consumption, there will be manufacturing clean room requirements which should be met to ensure the safety, stability and efficacy of the final product.
Airflow, humidity and temperature are carefully regulated and monitored during the growing process of the cannabis plant and similar, stringent standards are carried over into the extraction and packaging process of the CBD oil which is derived from the flower of the Cannabis plant.
This new emerging market will see Pharmaceutical companies adding CBD oil to their list of products as well as entrepreneurs entering this segment. It will also be necessary to categorize this extraction process into the family of Good Manufacturing Practice (GMP) legislature that guides the Pharmaceutical industry in South Africa.
GMP standards are specifically designed to minimise or prevent the risks involved in any pharmaceutical production that cannot be eliminated once the product has reached its final stage. These standards are primarily focussed on preventing cross-contamination as well as false or incorrect labelling. An integral part of GMP is to ensure the correct clean room classification is applied. With CBD oil being one of the Active Pharmaceutical Ingredients (API) as part of an herbal extraction process and administered orally it will fall within the ISO 7 classification for cleanroom category.
As leading suppliers of clean air equipment in South Africa we strongly believe in providing only the highest quality products to the end user, which is especially important when it comes to consumables such as CBD oil.
If you would like to find out more about the ISO 7 clean room classification and how it is appropriate for the manufacturing of CBD oil in South Africa, please contact us
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