NHP & Pharmaceutical Testing Services
NHPs (natural health products, sometimes known as nutraceuticals) and pharmaceuticals come under different regulatory frameworks. Although under different regulations, USP methodologies are generally used for both products.
NHPs range from vitamin supplements and herbal and probiotic products to toothpaste, and are legislated as natural health products. Drugs include medicines and medical devices, and are covered by therapeutic drugs legislation. The main difference between the two is that NHPs such as vitamins are taken for general wellness, whereas drugs target a specific disease, illness or medical condition.
I.G. MicroMed has a great deal of experience in this area. Our most common task is to establish product safety parameters for NHPs and pharmaceuticals, usually performing a standard package of bacterial testing. We can perform specific NHP tests including probiotic counts, or mycotoxin content, as applicable.
We also perform antimicrobial effectiveness testing (challenge testing) on both NHPs and pharmaceuticals to test the growth of bacteria, mold and yeast and pathogens to determine the product’s ability to inhibit such microorganisms. We can also test for growth promotion of your sterile media. I.G. MicroMed also offers environmental monitoring of sterile facilities. With our on-site technicians, particle counter, swabs and settle plates, we assist in ‘proving’ of your sterile facilities according to Health Canada requirements.
We are also in the process of having our clean room accepted in, accordance with Health Canada therapeutic drug and medical devices legislation, for sterility testing.
We utilize approved methods for the following testing:
- USP <2021> Microbial Enumeration Tests
- USP <61> Microbial Enumeration Tests –
- USP <2022> Microbial Procedures for the Absence of Specified microorganisms
- USP <51> Antimicrobial Effectiveness Testing
- USP <62> Tests for Specified
Microorganisms – Non Sterile Products
- USP <71> Steriility Tests
- Standard Plate Count (Aerobic Plate Counts)
- E. Coli
- Staphylococcus Aureus
- Pseudomonas Aeurginosa
- Yeast and Mold
- Total Probiotic Count(s)
- Water Activity
- Allergens (Gluten, Soy, Dairy, Eggs, Peanuts)
- Mycotoxins (Aflatoxin, Ochratoxin, Vomitoxin)
- Bacterial Identification(s)
- Fungal Identification(s)
- Mold Identification(s)
- Microscopic Examination(s)
*These are just the most common tests we perform. Let us know if you require something not listed.
I.G. MicroMed carries a current Health Canada Establishment License for testing facilities.