Dalgety produce Cannabis Flower as an Active substance manufactured to Good Manufacturing Practice (GMP).
An Active substance or Active Pharmaceutical ingredient is described as any substance intended to be used in the manufacture of a medicinal product and that, when so used, becomes an active ingredient of the medicinal product. Such substances are intended to have a pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure and function of the body.
To enable us to ensure the quality of this product we test this active substance in accordance with the European Pharmacopoeia (Ph. Eur.). A pharmacopeia is a reference book that provides official standards for the quality, purity, and strength of medicines, drugs, and active substances
Specifically, the monograph for Cannabis Flower (07/2024:3028) includes a suite of tests that provide a criteria to guide the quality of the product. The monograph however doesn’t include all of the testing that is required to establish the quality level but rather when using a pharmacopeia like the Ph. Eur. additional tests are included depending on the class of products.
For cannabis we also consider the Herbal Drugs General Monograph (07/2017:1433) This monograph provides additional tests that may be required dependant on the type of herbal drug and use.
One of these is the requirement for monitoring the level of Microbial contamination.
Where a dried herbal drug is used whole, cut or powdered as an ingredient in a medicinal product, the microbial contamination is controlled
This directs to two separate chapters
5.1.8. Microbiological quality of herbal medicinal products for oral use and extracts used in their preparation and 5.1.4. Microbiological quality of non-sterile pharmaceutical preparations and substances for pharmaceutical use.
Dalgety take a combination of tests and limits from both of these chapters and apply the most stringent limits.
For example, 5.1.8.b applies to Herbal drugs (Active Substance), where the method of processing pre-treatment reduces the levels of organisms. It has the following criteria based on the number of Colony Forming Units (CFU):
| TAMC (Total Aerobic Microbial Count) | Acceptance criterion: 104 CFU/g Maximum acceptable count: 50 000 CFU/g |
| TYMC (Total Yeast and Mould Count) | Acceptance criterion: 102 CFU/g Maximum acceptable count: 500 CFU/g |
| Bile-tolerant gram-negative bacteria | Acceptance criterion: 102 CFU/g |
| Escherichia coli | Absence (1g) |
| Salmonella | Absence (25g) |
Chapter 5.1.4 contains a criteria for medicines for Inhalation use, this is typically for products that are taken into the lungs or buccal cavity. Some patients vaporise the cannabis with heat in a medical device and the vapour inhaled. This is again a more stringent criteria consisting of the following:
| TAMC (Total Aerobic Microbial Count) | Acceptance criterion: 102 CFU/g |
| TYMC (Total Yeast and Mould Count) | Acceptance criterion: 101 CFU/g |
| Bile-tolerant gram-negative bacteria | Absence (1g) |
| Staphylococcus aureus | Absence (1g) |
| Pseudomonas aeruginosa | Absence (1g) |
Based on this Dalgety use this as an acceptance criteria
| TAMC (Total Aerobic Microbial Count) | Acceptance criterion: 102 CFU/g |
| TYMC (Total Yeast and Mould Count) | Acceptance criterion: 101 CFU/g |
| Bile-tolerant gram-negative bacteria | Absence (1g) |
| Staphylococcus aureus | Absence (1g) |
| Pseudomonas aeruginosa | Absence (1g) |
| Escherichia coli | Absence (1g) |
| Salmonella | Absence (25g) |
By using this criteria Dalgety flower is suitable for direct use as a flower following dispensing and suitable for onward processing into oils and oral products. This way we apply the most stringent levels for the Total Aerobic Microbial Count, Total Yeast and Mould Count and Bile-tolerant gram-negative bacteria. And include the additional screening for specified organisms that can cause problems in the lungs Staphylococcus aureus and Pseudomonas aeruginosa. And also include the screening for objectional organisms that cause problems in the digestive system Escherichia coli and Salmonella.
