Controlled environments for cannabis-derived products
Cannabidiol is widely known as CBD. The natural remedy may be used for common ailments such as pain relief and anxiety or as a food supplement with no medicinal claims. CBD is one of over 100 cannabinoids, which are chemical compounds found in the cannabis or marijuana plant and is different to the cannabinoid Delta-9-tetrahydrocannabinol (THC). Products containing THC for medical use are always categorised as medicinal cannabis.
There are two areas in which cleanrooms can support the production of cannabis-derived products.
- CBD extraction and oil production as a medicinal product or a food supplement
- Medicinal cannabis cultivation, collection and processing into an Active Pharmaceutical Ingredient (API) or a Medicinal Product
Cleanroom considerations for CBD extractors
For CBD extraction and oil production for medical use, manufacturers must work with the MHRA to satisfy the legal requirements of the Human Medicines Regulation Act 2012. Different parts of a production process will require different levels of environmental control. For example, CBD extraction will require tighter levels of control, than the drying and packaging stages.
Non-medicinal products may be exempt from requiring a product licence and could be potentially be manufactured in non-GMP cleanrooms if an exemption is granted. However, if your business has plans to obtain a product licence in future, it would be worth investing in a cleanroom that adheres to GMP cleanroom design principles.
Cleanroom considerations for medinical marijuana
Medicinal marijuana products, like all medicinal products, must have either a Product License (Marketing Authorisation or MA), an Investigational Medicinal Product (IMP) licence for use in Clinical Trials or supplied as a Special under Regulation 167 of the Human Medicines Regulations 2012, and must be manufactured according to EU GMP guidelines.
For medicinal cannabis cultivation, a cleanroom envelope with the right HVAC system can create a controlled environment with the optimum growing conditions for the production of the right cannabinoids. Cultivation areas, grow rooms or hydroponic grow systems can be linked to GMP areas for processes such as drying, processing, packaging and storage of the plant material.
Cleanrooms for non-medicinal applications
To be compliant with GMP guidelines, cleanrooms must control the level of airborne particulate, plus fulfil additional facility design requirements, e.g., fully-flush panels.Medicinal products will need to be produced in a GMP cleanroom.
ISO 14644-1 cleanrooms control the levels of airborne particulate and other environmental parameters—such as humidity and light—making them suitable for cultivation.Non-medicinal products may be able to be produced in ISO cleanrooms.
We can support you with an end-to-end service—from the design of your new CBD oil or medinical marijuana production, facility to validation testing and certification.
Speak to us today about your CBD cleanroom or medical marijuana project.
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