Microbes can cause infection and manufacturers of regulated products are obligated to maintain evidence that demonstrates that their products are free from microbial contamination. Microbes affect all classes of products and cause spoilage in foods and cosmetics. Since many natural health products contain herbal components, it is imperative to conduct full microbial testing prior to release for sale.
There are many different types of microbes and it would be difficult to conduct tests for all possible microbes in a given product. This is why the regulated industry has decided to test for a set of indicator organisms in each product. Each health product, prior to release for sale, needs to be tested for Total Aerobic Bacterial counts, e. Coli, Salmonella, Pseudomonas, Staphylococcus, Yeast and Mold.
In order to prevent spoilage due to microbial contamination one strategy in formulation is to include chemical agents that prevent microbial growth. These agents are broadly described as preservatives and are present at very low concentrations. In order to evaluate the efficacy of preservatives specific tests designed to challenge the concentration and effectiveness of these agents are conducted.
Different countries across the world have different specific tests for the evaluation of preservative efficacy. We provide international consultation services to answer your important requirements
In natural health products some vitamins (Vitamin B12, Folic Acid, Biotin, Pantothenic Acid) are included at micro-gram quantities. Consequently, instrumentation techniques such as HPLC are not sensitive enough to detect and quantify these ingredients at these levels.
Turbidimetric Analysis where specific organisms that utilize specific micro-vitamins to grow are often much more sensitive and can be employed when product matrices are complicated. In turbidimetric analysis the microbial growth is related to the concentration of the specific micro vitamins permitting quantification to the nanogram level.