Microbiological quality testing measures the total number of viable microorganisms in the finished product, expressed in Colony Forming Units per gram (CFU/g). This includes enumeration of total aerobic mesophilic bacteria (TAMC) and total yeasts and molds (TYMC), plus absence testing for specified pathogenic organisms. These tests confirm that the product is safe for topical application.
Testing follows internationally recognized ISO cosmetic microbiology standards: ISO 21149 for total aerobic mesophilic bacteria (TAMC), ISO 16212 for yeasts and molds (TYMC), with specified organism testing per ISO 22717 (P. aeruginosa), ISO 22718 (S. aureus), ISO 21150 (E. coli), and ISO 18416 (C. albicans). Results are reported as CFU/g with presence/absence for specified organisms, aligned to method and date of testing. Standards: ISO 21149, ISO 16212, ISO 22717, ISO 22718, ISO 21150, ISO 18416
Any product applied to skin or mucous membranes must be free from harmful microbial contamination. Ozone itself is one of nature’s most powerful antimicrobials, so properly ozonated glycerin is inherently self-preserving. However, results must still be demonstrated by method-compliant testing — not assumed. By citing specific ISO methods rather than generic CFU counts, our results are interpretable, auditable, and directly comparable to international cosmetic safety standards.
SimplyO3 Glyzine must achieve: TAMC ≤ 100 CFU/g (ISO 21149), TYMC ≤ 10 CFU/g (ISO 16212), and absence of specified organisms (S. aureus, P. aeruginosa, E. coli, C. albicans) in 1 g. Our manufacturing standard consistently achieves < 10 CFU/g total — 10× better than the acceptance limit.
Glyzine is processed under laminar flow hoods built to ISO 5 (Class 100) standards within an ISO 7 rated cleanroom, following ISO 9001 quality management guidelines. This means fewer than 100 particles (≥0.5μm) per cubic foot of air — the same standard used in semiconductor fabrication and pharmaceutical compounding. All equipment is sanitized before each production run, and all personnel follow strict gowning procedures. Petri dish plates are used for analyzing any bacterial growth as part of environmental monitoring.
Method: ISO 21149 (TAMC), ISO 16212 (TYMC) standard plate count.
How Plate Counts Work: Samples are diluted, plated onto agar media, and incubated at 30–35°C for 72 hours (TAMC) or 25°C for 5 days (TYMC). Visible colonies are counted manually. Each colony represents a single viable microorganism (or cluster) that grew from the original sample.
Inherent Precision: Colony counting is subject to Poisson statistics. The internationally accepted countable range is 30–300 CFU per plate (ISO 7218). At low counts (≤10 CFU/g, our typical result), the relative uncertainty is higher in percentage terms but the absolute uncertainty is small — for example, a result of “< 10 CFU/g” means the true count could reasonably be 0–20 CFU/g. At our acceptance limit of 100 CFU/g, the counting precision is approximately ±0.5 log₁₀ (a factor of ~3), consistent with standard microbiological practice.
Why ISO Standards Matter: We cite specific ISO method numbers (21149, 16212, 22717, 22718, 21150, 18416) rather than generic “microbial testing” because each standard specifies the exact medium, temperature, incubation time, and interpretation criteria. This makes our results reproducible by any accredited lab worldwide — not dependent on proprietary or unspecified methods.
What “< 10 CFU/g” Means: Our batches consistently achieve TAMC < 10 CFU/g — that is 10× below the acceptance limit of 100 CFU/g. Ozone itself is a powerful antimicrobial (it destroys cell membranes by oxidative attack), so properly ozonated glycerin is inherently self-preserving. The ISO-method testing provides documented proof of what the chemistry predicts.