Dietary Supplement Testing

Ensuring the safety of dietary supplements is critical. Microchem Laboratory provides the microbiology testing support you need.

Microchem is FDA-registered, ISO 17025 Accredited, and GMP/GLP compliant. Our Dietary Supplement tests range from USP compendial methods to rapid assays for microbial content and preservative challenge testing. We test finished products, ingredients, and can assist with out-of-specification events and microbiological monitoring of your manufacturing environment.

Nutritional and Dietary Supplement Testing

• USP 2021 (Test for microbial content of dietary supplements)
• USP 2022 (Test for the absence of specific pathogens)
• Validated USP 2021/2022 analog
• Test for the absence of Listeria monocytogenes
• Tests for the absence of specific pathogens
• DNA Identification of microbial contaminants
• Stability/shelf life for dietary supplements
• Preservative challenge testing for liquid dietary supplements.

Suitability Tests – Required Once per Product or Ingredient

Suitability tests are a critical step in dietary supplement testing, where microorganisms are intentionally added to finished products and ingredients in low, known quantities. The method is then run as ordinary on the inoculated samples and recovered microbial counts are compared to expected counts. If the numbers are roughly equivalent, then the method has been verified to be compatible with the dietary supplement and satisfies FDA’s requirement that the method be verified to be suitable with a given product.

When problems with suitability occur, they are usually due to antimicrobial properties of the ingredient or dietary supplement, or occasionally with physical properties of solids, such as powders. Microchem Laboratory has alternative methods available to deal with such difficult-to-test substances, and a deep expertise in engineering neutralization schemes for antimicrobial products.

Preservative Challenge testing for Dietary Supplements

For liquid dietary supplements, preservation strategy is critical. Microchem provides preservative challenge testing as necessary. Our methods are based on USP <51> preservative challenge test, modified for dietary supplements and food-borne pathogens. Preservative challenge tests are often customized for manufacturers depending on the microorganisms of concern, the manufacturing environment, and formulation of the liquid dietary supplement.

Support for Contaminated Products or Facilities

Most manufacturers of nutritional and dietary supplements will have to deal with products exceeding their specifications for microbial limits – contaminated products or ingredients – at some point in time. Microchem holds all information from its customers in absolute confidence, enabling you to work comfortably through the challenge with our expert staff. We have helped dozens of companies through contamination events via enhanced microbial surveillance, consultation regarding root cause and likely sources of microbial contamination.

Common causes of microbial contamination of dietary supplements include the following:

• Inadequate preservation of liquid products
• Contaminated ingredients
• Contaminated facility water
• Contaminated packaging

We also offer environmental swab studies within your facility. Microchem can help your company navigate the challenges associated with out-of-specification microbial limits results.

How to Get Started With Dietary Supplement Testing

Microchem makes it easy to test dietary supplements. We start by asking some basic questions about your company and manufacturing operations, such as where it’s located, how many batches you make daily, and what microorganisms are of concern. Then we issue price quotes and introduce you to an Analyst or Project Manager who becomes your main point of contact. To learn more about the tests offered to the dietary supplement industry, simply contact us today.