Which organization to optimize VIDAZA® production ?

P. Nizet, A. Lebreton, M. Chappe, L. Le Quay, F. Lagarce
Pharmacy, production unit, CHU d’Angers (France)

Introduction
According to the SPC, VIDAZA® is stable 8h between 2 °C and 8 °C if reconstituted with sterile water for injection (SWI) at ambient temperature, and 22h if reconstituted with cold SWI (2-8°C). Stability studies have been demonstrated a stability up to 5 days after reconstitution with cold SWI.
In 2018, our Cytotoxic Production Unit (CPU) produced 1,407 VIDAZA® preparations. 36 (2.56%) of these preparations were not administered and destroyed due to the 8h stability. The cost loss is estimated at 22,000€.

Objectives
The objective of this study was to optimize the reconstitution of VIDAZA®, in particular with cold SWI in order to increase its stability.

Methods
A brainstorming was held with the member of the unit composed of 9 pharmacist technicians, 2 pharmacists and a resident. Several solutions were proposed :

  • To use 500mL SWI Ecoflacs® stored in a Cold Storage Room(CSR)
  • To use 50mL glass SWI bottles stored in CSR
  • To use frozen 20mL SWI pods
  • To use 4mL SWI syringes previously filled in an isolator and stored in CSR
    For each proposition, temperature readings of the SWI were made using a thermometer to measure time elapsed between the exit of cold storage room and a temperature above 8 °C.

Results
The proposal to use 20mL frozen SWI pods was rejected because of the necessity a needle for the sampling.
The temperature of Ecoflacs® 500mL SWI was higher than 8 °C in on average 17,20min which makes the preparation difficult if we subtract the time of sterilization (15min).
The temperature of the 50mL vials of glass SWI was higher than 8 °C in on average 6.50min and the temperature of the 4ml SWI syringes previously filled was higher than 8 °C in on average 2min20.
These last two solutions seem conceivable by storing the containers in a sterile box in a cold storage room that will be connected at the time of preparation.

Discussion/Conclusion
The use of 4mL syringes of SWI previously filled in isolator and stored in CR in a sterile box has been adopted. This organization allows to save time during the preparation of VIDAZA® and avoids a significant cost loss.

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