Patent ID: 6455272
Filing Date: 2002-09-24
Classification: A61L

Abstract:
Method enabling multiple evaluations, utilizing a single sterility test device, of bacterial sterilizing effectiveness on a thermal sterilizer load after carrying out designated steps of a selected saturated-steam sterilizing cycle, comprising,A. providing a plurality of sterility test devices, each: (i) having a size and configuration enabling evaluations of sterilizing effectiveness by selecting at least one difficult-to-load location for placement of an individual test device for testing sterilizing effectiveness throughout such sterilizer load, (ii) containing an aqueous fluid-state indicator material with constituents which respond to steps of such cycle in a manner correlated to sterilizing effectiveness on bacterial spores of a load exposed to the same steps of such cycle, (iii) having an exterior barrier capable of transmitting electromagnetic radiation enabling spectroscopic peak absorption measurements of such fluid state indicator at specified wavelength spectra; B. providing for exposure, of such indicator material to such cycle, so as to enable selection from the group consisting of: (i) an early load-release evaluation of sterilizing effectiveness, which is available by: (a) quantitatively measuring peak absorption of electromagnetic radiation of specified wavelength spectra resulting from chemical change due to the presence of a predetermined composition of carbohydrates which comprises a growth nutrient for bacterial spores, in solution in such indicator material exposed to such cycle, with (b) at least one such peak absorption measurement due to such chemical change being available directly upon completion of such cycle utilizing an electromagnetic radiation wavelength in the UV spectra, so as to (c) provide an indication selected from the group consisting of: indicating to directly release such sterilizer load as exposed to steps of such cycle, and indicating added sterilizing efforts on such load should be required before such release; (ii) a further early-load-release evaluation of sterilizing effectiveness which is available by: (a) quantitatively measuring for peak absorption of electromagnetic radiation resulting from/the exposure of an organic pH indicator, in solution in such indicator material of such test devise exposed to such cycle, (b) which pH indicator is selected to avoid inhibiting later incubated spore growth, if any, and is non-toxic to cells resulting from any such spore growth, with (c) such peak absorption measurement due to presence of such pH indicator, being available directly upon completing such cycle, utilizing an electromagnetic radiation wavelength in the visible light spectrum, so as to, (d) provide an indication selected from the group consisting of: indicating a direct release of such sterilizer load as exposed to designated steps of such cycle, and indicating that added sterilizing efforts on such load should be required before such release; C. enabling a further evaluation of bacterial sterilizing effectiveness, by: (i) positioning live spores within such exterior barrier of such test devise so as to be capable of being exposed to steps of such cycle, so as to: (ii) provide for growth of live spores, if any, in such test device due to establishing contact with such carbohydrate composition which comprises a growth nutrient for spores following a predetermined culture period for spores.