Microbial Contamination of Botanical Products
Botanicals used for making botanical products may become contaminated with microbes during any point of cultivation, harvest, processing, packaging, and distribution. In order to ensure a botanical product is safe for consumer use or consumption, manufactures must follow Good Manufacturing Process, and ensure microbial specifications are meet through routine testing.
It may be necessary for manufactures to screen each raw ingredient separately prior to formulation, in order to evaluate which may have high microbial contamination. Ingredients with high microbial contamination can be pre-treated with a specific control process such as: drying, extraction, irradiation, or sterilization treatment to remove the source of contamination.
Testing plans for microbial contamination of botanicals vary depending on the type of product that is being manufactured. Botanical powders may have more variation in microbial contamination than products that are highly processed.
Whatever the product type, Twin Arbor Labs offers a wide variety of microbial services to ensure the product meets microbial specifications. See the tables below for a list of definitions of botanical products and their recommended microbial limits set by the US Pharmacopeia.
Chopped or powdered
Description
Recommended Microbial Limit (cfu/g or mL)
Hand-picked portions of the botanical (leaves, flowers, roots, tubers…etc.) that are air dried and chopped, sectioned, ground or pulverized to the consistency of a powder.
Total Aerobic Plate Count
Total Yeast and Mold Plate Count
Total Bile-tolerant Gram-negative Bacterial Plate Count
10^5
10^3
10^3
Salmonella spp. and E. coli in 10g
Non Detect
Extracts
Description
Recommended Microbial Limit (cfu/g or mL)
Solid or semi-solid preparations of the botanical that are extracted in an aqueous solution, filtered, and concentrated by evaporation. Extracts are usually 4 to 10 times stronger than the original botanical.
Total Aerobic Plate Count
Total Yeast and Mold Plate Count
Total Bile-tolerant Gram-negative Bacterial Plate Count
10^4
10^3
NA
Salmonella spp. and E. coli in 10g
Non Detect
Tinctures
Description
Recommended Microbial Limit (cfu/g or mL)
Solutions of botanical substances in alcohol obtained by extraction of the powdered, flaked, or section botanical.
Total Aerobic Plate Count
Total Yeast and Mold Plate Count
Total Bile-tolerant Gram-negative Bacterial Plate Count
10^4
10^3
NA
Salmonella spp. and E. coli in 10g
NA
Infusions
Description
Recommended Microbial Limit (cfu/g or mL)
Solutions of botanical substances in water obtained by soaking in hot or cold water for a specific time, and then straining the botanical out. Infusions and decoctions are usually 5% the strength of the original botanical.
Total Aerobic Plate Count
Total Yeast and Mold Plate Count
Total Bile-tolerant Gram-negative Bacterial Plate Count
10^2
10
NA
Salmonella spp. and E. coli in 10g
NA
Nutritional supplements
Description
Recommended Microbial Limit (cfu/g or mL)
Products made from plants, plant parts, or plant extracts. They are meant to be consumed and contain one or more ingredients meant to supplement the diet.
Total Aerobic Plate Count
Total Yeast and Mold Plate Count
Total Bile-tolerant Gram-negative Bacterial Plate Count
10^3
10^2
NA
Salmonella spp. and E. coli in 10g
Non Detect