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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 |
