TRBIOSECURE ISBT & Monitoring
Process management for haematopoietic transplant and apheresis units: diagnosis and donor workup, cell order, collection, processing, cryopreservation, storage, infusion and disposal, with ISBT 128 labeling throughout.
AvailableA haematopoietic product changes hands several times between collection and infusion: the apheresis unit, the processing laboratory, cryogenic storage and the transplant ward. At every handover the unit must be able to show whose product it is, what was done to it and under which conditions it has been held. This module keeps that chain in one record.
Process coverage
| Step | What it gives you |
|---|---|
| Diagnosis and patient record | The whole process hangs off a single diagnosis |
| Donor eligibility | Donor details and tests kept separate in the allogeneic flow |
| Patient tests | The pre-collection serology panel can be filled from laboratory results |
| Scheduling | Collection date, mobilization details and a clash warning |
| Clinical approval | A final check on one screen before proceeding |
| Quality tests | Before and after collection, CD34 included |
| Product collection | Several bags in one collection, with different product types together |
| Labeling | The Donation Identification Number is assigned and the ISBT 128 label printed from the application |
After collection, processing, infusion and transfer are routes the institution chooses; there is no mandatory order between them. A frozen product passes through a thaw step before infusion.
ISBT 128 labeling
Labels are printed from the system according to the ICCBBA standard: a globally unique Donation Identification Number, the international product description code, and the label layout defined for collection, processing and final product levels. Because the standard is not in the public domain, implementation requires registration with ICCBBA and an annual license; we work with registered software on this basis.
Accreditation and audit
The record structure follows FACT-JACIE International Standards for Hematopoietic Cellular Therapy: traceability at every step, quality management records including deviations and corrective actions, and structured clinical outcome fields for day 100 and one-year reporting. Audit preparation becomes a query rather than months of manual evidence gathering.
Storage conditions are part of the product record
Ultra-low temperature freezers, liquid nitrogen tanks, controlled-rate freezers and room conditions are monitored through GE-MON. When an excursion occurs, the affected products are listed directly rather than reconstructed from separate systems.
Talk to our team
We can share how a comparable transplant program is configured, without naming the institution.