Risk Analysis with Cell Therapy Products Related to Input Materials—Packaging, Storage and Administration
| Input Materials | Risk Identification | Risk Rating | Risk Mitigation/Critical Process Controls |
|---|---|---|---|
| Packaging | I.V. bags | Low | Irradiation sterilization; aseptic transfer Container-closure integrity |
| Storage | Ambient temperature; refrigeration temperature; frozen/cryopreserved | Low | Frozen storage should include liquid nitrogen vapor not liquid nitrogen |
| Shipping | Refrigerated or frozen | Low | Shipping frozen in liquid nitrogen or controlled refrigerated transport |
| Donor/Recipient | Allogeneic only | Moderate-High | Vaccination; pre- and post-antibiotic treatment |