Validation of ready-to-use bags for anticancer drug administration : microbiological stability and physical integrity
2 : Université de Paris Sud
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As part of the implementation of the standardisation of doses of anti-cancer drugs, the pharmacy for internal use wishes to manufacture batches of chemotherapy bag preparations in advance. The current manufacturing process involves priming a solvent purged infusion line connected to the bag.
The objective of this study is to validate the microbiological stability and physical integrity of the bags connected to the infusion lines during the entire storage life.
Aseptic filling of a trypticase soya medium is carried out on 550 bags with connected tubing. The bags are over-packed in a leak-proof poly bag and stored under controlled temperature conditions (20°C+/-2°C) identical to the routine.
Three arms are defined: a standard arm of 30 bags per study time (simple observation of the environment after storage), a worst-case arm of 15 bags per study time and per germ (voluntary contamination by micro-organisms at the bags-tubing connection point) and a positive control arm of 1 bag per germ to facilitate reading of the bags. Voluntary contamination was done with 10^3 CFU of different strains (bacteria, yeasts and moulds). Sterility tests were carried out, as well as a fertility test of the medium. A visual reading was carried out after 15 days of incubation at 20°C of the bags after voluntary contamination.
Physical integrity was evaluated on 5 0.9% NaCl bags connected to purged infusion lines by a bubble point test at the bag-infusion line connection (pressurisation of the bags and observation of the bubble).
An evaluation of solvent evaporation from the tubing was performed on 30 bags by weighing the amount of solvent present in the tubing.
All operations were repeated at D0, D10, 30, 60 and 90.
The environment remained fertile and sterile throughout the study. No microbial growth was observed in the standard and worst-case arms under the storage conditions of the study. The physical integrity tests were performed between D0 and D90. A weight loss of more than 10% in the tubing at D60 shows evaporation in the tubing which is also visible (bubble formation).
The use of a bag-infusion line connection in the context of chemotherapy does not interfere with the physical integrity and sterility of the bag over 60 days.