Author/Editor     Frumen, Metka; Vidergar-Kosec, Andreja
Title     Validacija procesa dekontaminacije v dekontaminacijski komori
Type     članek
Source     In: Bole-Hribovšek V, Ocepek M, Klun N, editors. Zbornik s programom 2. kongres slovenskih mikrobiologov z mednarodno udeležbo; 1998 sep 27-30; Portorož. Ljubljana: Slovensko mikrobiološko društvo,
Publication year     1998
Volume     str. 385
Language     slo
Abstract     The purpose of the decontamination validation procedure is to prove, that the process of the surface desinfection of the material used in the aseptic conditions is satisfactory. Validation should be performed periodically on standard loads. 9% hydrogen peroxide in ethanol is used as disinfectant. Presterilised surfaces of ampoules are inoculated with Bacillus subtilis var. niger ATCC 9273 spore suspension (103 CFU/ml). Dried inoculated ampoules are transffered into the chamber to the predefined worst case locations. When the decontamination procedure is completed, samples are transffered into fluid TSA and thioglycollate media and incubated 14 days at prescribed temperatures. Positive and negative controls must be performed as well. The procedure is satisfactory if no growth of microoganisms is observed in any of test media except in positive controls.