PharmTech.com Trends in Manufacturing eBook May 2024 Pharmaceutical Technology
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7
Biologics
TABLE I. Comparability of the BD Bacterial Automated Detection and
Enumeration (BACTEC) rapid sterility method and compendial method
in the suitability test. Time to detection is recorded for BACTEC FX40.
*The compendial samples were evaluated only on working days. The
positivity could have been detected one/two days earlier.
Tested sample Microorganism 100 CFU BACTEC FX40 Direct inoculation
CAR-T-1 Clostridium sporogenes 18 h 15 min 1 day
CAR-T-2 15 h 13 min 1 day
CAR-T-3 15 h 3 min 1 day
Positive control 14 h 3 min 1 day
CAR-T-1 Cutibacterium acnes 3 days 17 h 37 min 5 days *
CAR-T-2 3 days 8 h 8 min 2 days
CAR-T-3 2 days 20 h 37 min 5 days *
Positive control 3 days 2 h 6 min 5 days *
CAR-T-1 Staphylococcus aureus 14 h 34 min 3 days *
CAR-T-2 14 h 5 min 3 days *
CAR-T-3 14 h 8 min 3 days *
Positive control 14 h 39 min 4 days
CAR-T-1 Streptococcus pyogenes 13 h 35 min 3 days *
CAR-T-2 13 h 16 min 3 days *
CAR-T-3 13 h 40 min 3 days *
Positive control 12 h 3 days *
CAR-T-1 Brachybacterium nesterenkovii 1 day 8 h 38 min 3 days *
CAR-T-2 1 day 8 h 39 min 3 days *
CAR-T-3 2 days 23 h 40 min 3 days *
Positive control 1 day 8 h 40 min 3 days *
CAR-T-1 Pseudomonas aeruginosa 15 h 6 min 3 days *
CAR-T-2 15 h 3 min 3 days *
CAR-T-3 15 h 4 min 3 days *
Positive control 15 h 37 min 3 days *
CAR-T-1 Bacillus subtilis 10 h 49 min 2 days
CAR-T-2 12 h 7 min 1 day
CAR-T-3 11 h 48 min 1 day
Positive control 11 h 54 min 1 day
CAR-T-1 Candida albicans 1 day 2 h 8 min 2 days
CAR-T-2 1 day 3 h 46 min 1 day
CAR-T-3 23 h 35 min 1 day
Positive control 1 day 4 h 27 min 3 days
CAR-T-1 Aspergillus brasiliensis 1 day 11 h 5 min 3 days
CAR-T-2 2 days 10 h 50 min 2 days
CAR-T-3 1 day 20 h 21 min 2 days
Positive control 1 day 14 h 35 min 3 days
