Background Vidaza (azacitidine), comes in vials of sterile lyophilised powder for reconstitution with water for injections in a controlled environment. After reconstitution, chemical and physical in-use stability of the finished product has been demonstrated at 25°C for 45 min; at 2–8°C for 8 hours; and at 2–8°C for 22 hours when Vidaza is reconstituted using refrigerated (2–8°C) water for injections. Our centralised reconstitution unit prepares chemotherapy for a public hospital which is located 47 km away.
Purpose The objective of our study was the conservation of the cold chain for the reconstitution of Vidaza using refrigerated water in order to assess the feasibility of preparing Vidaza off-site.
Material and methods We created an organisational chart that illustrated the reconstitution of Vidaza to target critical points. Average temperature measurements of each step of the Vidaza reconstitution were obtained using a digital thermometer probe. Cold chain compliance was obtained when the temperatures recorded were between 2°C and 8°C.
Results The results showed that refrigerated water for injection introduced into the isolator through the sterilisation chamber reached an average temperature of 10.7°C. The same experiment with frozen water for injection led to an average temperature of 9.6°C. Refrigerated, sterile water for injection once in the isolator can be placed in the rapid transfer port (RTP) system. This removable system stored in a freezer and then reconnected to the isolator provides refrigerated water for injections at an average temperature of 3.4°C after complete thawing. After reconstitution, the finished products are immediately stored in the refrigerator and transported to oncology units in coolers with time/temperature recordings to monitor the temperature. Syringes are received at an average temperature of 6°C at the public hospital located 47 km away. Therefore, syringes of Vidaza can be prepared using the RTP system and should be sent to oncology units or transported to the external public hospital in coolers.
Conclusion This study confirms the feasibility of cold chain conservation in the reconstitution of Vidaza in isolators and the feasibility of the subcontracting activity. It also strengthens collaboration between hospitals in the same catchment area and encourages the development of haematology activities in the subcontracting hospital.
References and/or acknowledgements Vidal.
No conflict of interest
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