Table 6 Release criteria for MyDerm®
Test | Specification |
|---|---|
Physical characteristics | |
Viability |  ≥ 70% |
Total number of keratinocyte passages |  ≤ 6 |
Keratinocyte cell count | up to 2 × 107 (depending on size) |
Total number of fibroblast passages |  ≤ 6 |
Fibroblast cell count | up to 2 × 107 (depending on size) |
Product released |  ≤ 72 h from end of manufacture |
Sterility testing | |
Micro-contamination testing | Not Detected |
Mycoplasma testing | Not Detected |
Endotoxin testing |  < 0.25 EU/ml |
Gram stain | No organisms detected |