PRODUCT SPECIFICATIONS.
Technical data sheets for biotic preparations.
Technical Data
Consumer products fail because of formulation instability. Our specifications mandate 18-month viability curves at 25°C/60% RH. Synbiotics must demonstrate synergistic, not just additive, effects where the chosen prebiotic specifically supports the viability or function of the paired probiotic strain (FDA CBER Guidelines, 2023).
Specification Tolerances
| Metric | Acceptance Criterion | Testing Method |
|---|---|---|
| Water Activity (aw) | < 0.15 | Hygrometer / Dew Point |
| Total Viable Count | ≥ 1.0 x 10^10 CFU/g at end of shelf life | Plate Count / Flow Cytometry |
Tool: Synbiotic Synergism
Common Mistakes in Formulation
- Using hygroscopic prebiotics in a capsule with freeze-dried probiotics. The fiber pulls moisture, breaking the dormancy of the strain and killing it before the consumer opens the bottle.
- Relying on "input at manufacture" claims rather than guaranteeing end-of-shelf-life viability metrics.
FAQ Section
What is Water Activity (aw)?
It measures the unbound water in a product available for microbial growth or chemical reactions. Low aw is critical for maintaining stability in lyophilized powders.
How are these tested?
Through real-time stability protocols and Flow Cytometry to differentiate between live, dead, and active-but-non-culturable (ABNC) cells based on our strict scientific standards.