USP <61> determines total aerobic microbial count (TAMC) and total yeast and mold count (TYMC) in non-sterile products. USP <62> tests for specified organisms — Salmonella, E. coli, S. aureus, Pseudomonas, and bile-tolerant gram-negatives. Together they define whether a product meets its compendial microbiological quality standard.
Non-sterile pharmaceutical products and dietary supplements must meet defined microbiological limits to protect consumers. Contaminated product recalls and FDA warning letters frequently cite inadequate microbial testing.
FDA 21 CFR 111 cGMP regulations require finished supplement manufacturers to test for microbiological quality. TAMC/TYMC results go on the product COA.
Herbs, mushrooms, and plant-derived ingredients carry high inherent bioburden from soil contact. Incoming material testing protects downstream product quality.
CMOs running multiple product lines must test each batch for microbial quality. We accept multi-product submissions with individual COAs per batch.
Cosmetics and OTC topical drug products face USP <62> requirements for specified organisms, particularly Pseudomonas aeruginosa and S. aureus.
In-process and finished water systems used in pharmaceutical manufacturing require periodic bioburden testing per USP <1231> and cGMP schedules.
Functional food and nutraceutical brands selling into natural retail channels increasingly require USP-format microbiological COA from distributors.
Our standard microbial limits panel covers:
Submitting takes less than 5 minutes. Most projects turn around in 5–10 business days from sample receipt.
Send a brief project description — sample type, quantity, and timeline. We confirm turnaround and quote within one business day.
We'll send a submission form and our San Diego shipping address. Most samples ship ambient or cold depending on stability requirements.
Results are delivered as a signed PDF COA within the agreed turnaround. Rush service (2–3 business days) is available for urgent timelines.
Send us your samples and receive an ISO 17025 accreditation pending Certificate of Analysis. Results in 5–10 business days.