BackgroundComparison of two recommended European Pharmacopoeia 9th Ed methods of sterility assay (membrane filtration versus direct seeding (DS)) highlights an important difference of sensitivity threshold. This threshold by membrane filtration method is at least lower or equal to 0. 14UFC/mL.PurposeThe aim of the study is to determine the sensitivity threshold of the DS method. This method is currently used in our Hospital Pharmacy Unit (HPU) for binary parenteral nutrition (PN) bags.Material and methodsFor this study, four bags of 30 mL, with a representative composition to those produced each day were each sown by a calibrated strain Bioball® 30 UFC (Candida albicans, Bacillus subtilis, Staphylococcus aureus, Pseudomonas aeruginosa) in order to obtain a concentration of 1UFC/mL. Then, four levels of dilution were carried out from each PN bag: 0.8 UFC/mL, 0.6 UFC/mL, 0.4 UFC/mL, 0.2 UFC/mL. For each level of dilution, 5 × 1 mL of each bag were taken in order to sow five cultures media, sabouraud dextrose agar slope (biomérieux) or Brain-Heart Infusion Broth (BHIB – comic) according to the strain. Culture media BHIB were incubated for 3 days at 37°C, then 11 days at 22°C, while the culture media sabouraud were incubated for 14 days at 22°C.ResultsAfter 14 days of incubation, for each strain tested, there were between 0 and 4 growths according to the dilution’s level. No concentration made it possible to have 100% of positivity, so sensitivity’s threshold is thus higher than 1UFC/mL. Compared to membrane filtration, the detection’s threshold by DS is at least seven times superior.ConclusionEven if this study did not estimate with precision a sensitivity threshold for the DS method, it has highlighted the limits for sterility assay of binary parenteral nutrition bags. So it possible to confirm the superiority of the membrane filtration method. Tests with higher micro-organisms’ concentrations in binary PN bags are planned to establish with precision the minimal detection threshold.No conflict of interest
patients who collected medicines from the pharmacy. This included adult male and female patients above 12 years. Their responses were recorded and tallied in the register book. This study was carried out between October 2017 and December 2017. Results Eleven factors were established. Out of 5235 patients who received pharmaceutical services, 1641 patients were interviewed. The dispensing design factor represented 23.45%, while the least was the language factor with 0.24%.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.