Background Due to an increase in production of chemotherapeutics, we implemented dose banding of chemotherapeutic drugs to prevent errors and improve the quality of cytotoxic drug preparation. The standard sterility tests recommended by the European Pharmacopoeia on chemotherapeutic batches are time consuming (14 days incubation before the final result).
Purpose The goal of the study was to create a more sensitive sterility test, which assured a more rapid and reliable result and reduced the period of quarantine of chemotherapeutic infusions from that batch.
Material and methods We investigated the BacT/ALERT FA (BioMérieux) culture bottles (ref 410851) as a rapid microbiological method. Microbiological growth creates CO2 production which is detected by an automatic photometric method. We inoculated the bottles with 1 of 4 standard microorganisms (10–100 colony forming units) which are recommended in the European Pharmacopoeia (Staphylococcus aureus (SA, ATCC6538), Pseudomonas aeruginosa (PA, ATCC9027), Bacillus subtilis (BS, ATCC6633) and Candida albicans (CA, ATCC10231)). We compared every step with a traditional trypcase soy broth (BioMérieux, ref 42633) with a phased incubation period (14 days) as recommended in the PIC/s. We also had to take into account the possible inhibition of microorganism growth by the cytotoxic drugs. We tested bacterial growth with the highest cytotoxic batch concentration, 0.4 mg/mL for paclitaxel and 1.9 mg/mL for trastuzumab.
Results All microorganisms were detected in the BacT/ALERT culture bottles with or without cytotoxic drug. The rapid microbacterial method was, as expected, more sensitive and easier in detection than the classic method, with a difference of 7 days. Paclitaxel had a low inhibiting effect on the growth of Pseudomonas aeruginosa and Candida albicans.
Conclusion BacT/ALERT culture bottles can successfully be implemented in a hospital pharmacy production unit. Our goal to instal a more sensitive and rapid detection method for sterility testing was achieved and led to a more secure system in the release of chemotherapeutic infusions. Further research with other cytotoxic drugs will be needed to validate this method.
No conflict of interest
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