Table 5.
The European Pharmacopoeia 10.0 criteria for efficacy of antimicrobial preservation.
| Ph. Eur. 10.0. Requirements (Logarithm of Reduction in Time Tx) | ||||||||
|---|---|---|---|---|---|---|---|---|
| Microorganisms | Bacteria * | Fungi ** | ||||||
| Sampling Time | T2 | T7 | T14 | T28 | T2 | T7 | T14 | T28 |
| Criterion A | ≥2 | ≥3 | - | ≥3 i NI | - | - | ≥2 | ≥2 NI |
| Criterion B | - | - | ≥3 | ≥3 i NI | - | - | ≥1 | ≥1 i NI |
Tx—time of performing measurements where “x” refers to the number of days; NI—the number of viable microorganisms does not increase compared to the previous reading; * Pseudomonas aeruginosa ATCC 9027, Staphylococcus aureus ATCC 6538, Escherichia coli ATCC 8739; ** Candida albicans ATCC 10231, Aspergillus brasiliensis ATCC 16404.