Microbiology Testing: Microbial Limits for Raw Materials & Finished Goods
Total plate count, yeast/mold, pathogens, and USP <61>/<62> compliance. Protect your products and consumers from microbial contamination.
Ayah Labs performs microbiology testing per USP <61> and <62> for dietary supplements and cosmetics. We test for total aerobic microbial count, total yeast and mold count, and specified pathogens including E. coli, Salmonella, S. aureus, and P. aeruginosa.
Microbial contamination is one of the most serious quality and safety risks in supplement and cosmetic manufacturing. Contaminated products can cause serious illness, trigger FDA recalls, and destroy brand reputation. USP <61> and <62> establish the standard methods and acceptance criteria for microbial limits testing of non-sterile pharmaceutical and dietary supplement products. Ayah Labs provides comprehensive microbiology testing services for raw materials and finished goods.
USP <61> and <62> Microbial Limits Testing
USP <61> (Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests) and USP <62> (Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms) are the standard methods for microbial limits testing of dietary supplements and pharmaceutical products. We perform total aerobic microbial count (TAMC), total combined yeast and mold count (TYMC), and tests for specified pathogens including E. coli, Salmonella, Staphylococcus aureus, and Pseudomonas aeruginosa.
Microbiology Testing for Raw Materials
Botanical raw materials, protein powders, and other natural ingredients are particularly susceptible to microbial contamination due to their agricultural origin and processing history. Testing incoming raw materials for microbial limits before use in production is required under FDA 21 CFR Part 111 and is critical for protecting finished product quality. We test all raw material types and can provide results against your internal specifications or USP acceptance criteria.
Cosmetic Microbiology
Cosmetic products require microbiology testing to ensure consumer safety and regulatory compliance. We perform microbial limits testing for cosmetics per USP and ISO 17516 methods, as well as preservative efficacy testing (PET/challenge testing) to verify that your preservative system is effective against the specified challenge organisms. Our cosmetic microbiology testing supports EU and FDA compliance requirements.
Tests & Methods Included
- ✓ Total aerobic microbial count (TAMC) per USP <61>
- ✓ Total yeast and mold count (TYMC) per USP <61>
- ✓ E. coli detection per USP <62>
- ✓ Salmonella detection per USP <62>
- ✓ Staphylococcus aureus detection per USP <62>
- ✓ Pseudomonas aeruginosa detection per USP <62>
- ✓ Bile-tolerant gram-negative bacteria
- ✓ Preservative efficacy testing (PET)
- ✓ Antimicrobial effectiveness testing (AET)
- ✓ Environmental monitoring
Regulatory Standards & Compliance
- USP <61>
- USP <62>
- FDA 21 CFR Part 111
- ISO 17516
- GMP
Industries We Serve
- Supplement Manufacturers
- Cosmetic Brands
- Contract Manufacturers
- Food Manufacturers
- Raw Material Suppliers
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Pricing depends on your product and test requirements. Tell us what you need and we will email a detailed quote within 24 hours.
Get a Quote →Frequently Asked Questions
What is the difference between USP <61> and USP <62>?
USP <61> covers microbial enumeration tests — counting the total number of aerobic microorganisms and yeast/mold in a sample. USP <62> covers tests for specified microorganisms — detecting the presence of specific pathogens like E. coli, Salmonella, S. aureus, and P. aeruginosa. Most supplement and cosmetic products require both types of testing.
How long does microbiology testing take?
Microbiology testing requires incubation time. Total plate count and yeast/mold results are typically available in 5–7 business days. Pathogen testing (USP <62>) takes 5–7 business days. We cannot accelerate microbiology testing without compromising the validity of results.
What are the USP acceptance criteria for dietary supplements?
USP acceptance criteria depend on the product category. For oral dietary supplements, typical limits are TAMC ≤ 10,000 CFU/g, TYMC ≤ 1,000 CFU/g, and absence of E. coli and Salmonella. Botanical products may have different limits. We will apply the appropriate criteria for your product type or test against your internal specifications.
Why manufacturers choose Ayah Labs for microbiology testing
Fast turnaround
Signed CoA in 48–72 hours
Direct scientist access
Talk to the scientist running your tests
No minimums
1 SKU or 100 — same quality
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