Bioburden

A bioburden is the amount of microbial load, specifically native bacteria or fungi, present on a substance or surface before it has been sterilised.

To make sure medications and pharmaceutical products are safe to use and do not contain any harmful bacteria or contaminants, they should undergo a bioburden analysis test before being placed on the market.

 

Why is bioburden analysis important?

 

Sometimes known as microbial limit testing, bioburden testing evaluates and establishes the quantity of microorganisms or bacteria present in a substance before it is sterilised. This acts as a quality control measure by exposing any contaminants so that scientists and manufacturers can ensure they are removed, and are not detectable in the final product. 

Adhering to regulatory standards for bioburden testing is essential to ensuring patient safety and product efficacy and integrity. Once these contaminants have been identified, they can be removed to sterilise the product so that it is safe to use. 

 

How are bioburdens measured?

 

Bioburdens are quantified in a microbiological measurement called CFU, or colony forming unit. The quantity of CFUs in a particular sample is used to determine how pure, or clean, a substance is. 

 

What are common sources of bioburdens in medical cannabis?

 

In medical cannabis, and in pharmaceutical manufacturing more generally, the primary sources of bioburden contamination are from the personnel or raw materials involved, and a lack of environmental control, such as poor cleaning practices or ineffective equipment. 

 

How are bioburdens extracted from cannabis?

 

There are a number of different bioburden extraction methods. Some involve sonication, which uses sonic energy to remove toxins or contaminants, whilst others use methods of agitation, such as vortexing, hand shaking or vertical and horizontal hand shaking, to separate contaminants from a substance.  

If you would like to learn more about medical cannabis in the UK, Releaf is here to help.