A two-centre validation study of sterility test of corneal storage media with elimination of interfering antimicrobials in compliance with the European Pharmacopoeia

Vignola, R.; Mistò, Raffaela; Giurgola, Laura; Pateri, Francesca; Pocobelli, Augusto; Tóthová, Jana DʼAmato

doi:10.1007/s10561-019-09766-7

Cited by 1 publication

(1 citation statement)

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“…RESEP is a syringe-like, patented, CE-marked device containing a resin mixture to remove antimicrobials from the samples. 26 It has been validated for total elimination of antimicrobials from corneal storage media, [27][28][29] including Kerasave (online supplemental tables 1 and 2). The validation of the method for removing antimicrobial residues from Kerasave was performed according to the experimental design reported in online supplemental figure 1.…”

Section: Media and Devicesmentioning

confidence: 99%

Killing efficacy of a new hypothermic corneal storage medium against the micro-organisms frequently found in human donor cornea intended for transplantation

Giurgola¹,

Gatto²,

Honisch

et al. 2021

BMJ Open Ophth

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ObjectiveTo study the in vitro killing efficacy of Kerasave (AL.CHI.MI.A Srl), a medium provided with amphotericin B tablet for hypothermic storage of human donor corneas, against relevant contaminants associated with postkeratoplasty infections.Methods and AnalysisThe antimicrobial activity of Kerasave was determined after 0, 3 and 14 days of incubation at 2°C–8°C, inoculating Kerasave and the control medium with 105–106 colony forming units (CFU) of Candida albicans (CA), Fusarium solani (FS), Aspergillus brasiliensis (AB), Staphylococcus aureus (SA), Enterococcus faecalis (EF), Bacillus subtilis spizizenii (BS), Pseudomonas aeruginosa (PA), Enterobacter cloacae (EC) and Klebsiella pneumoniae (KP). Log10 reductions at different time intervals were determined by assessing the number of viable CFU using the serial dilution plating technique.ResultsAfter 3 days, Kerasave induced the highest log10 decrease in the concentrations of KP, PA, CA and EC (5.37, 4.15, 2.97 and 2.67, respectively; all p<0.001). The log10 decreases of SA and EF were 2.27 and 2.11, respectively (all p<0.001). The lowest log10 decrease was observed in BS, AB and FS concentrations (0.25, 0.30 and 0.67, respectively; p<0.001 for BS and AB and p=0.004 for FS). After 14 days, the microbial count of CA, FS, SA, EF, PA and EC further decreased (p=0.006 for FS; p<0.001 for the others).ConclusionKerasave effectively reduced or kept unchanged the microbial concentration of almost all tested strains after 3 days. Thus, this novel medium represents a valuable tool to control the microbial contamination of human donor corneas during hypothermic storage for up to 14 days before transplantation.

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