BIOLOGICAL INDICATOR FOR MONITORING A LOW-TEMPERATURE STERILIZATION PROCESS

• Main Authors: BENNAARS-EIDEN ASSUMPTA, FOLTZ WILLIAM E, SWAMINATHAN SWARNALATHA, AHIMOU FRANCOIS
• Format: Patent
• Language: English
• Published: 07.01.2016
• Subjects: APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; BEER; BIOCHEMISTRY; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, ORSURGICAL ARTICLES; CHEMISTRY; COMPOSITIONS OR TEST PAPERS THEREFOR; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL ORENZYMOLOGICAL PROCESSES; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; ENZYMOLOGY; HUMAN NECESSITIES; HYGIENE; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICALARTICLES; MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEICACIDS OR MICROORGANISMS; MEDICAL OR VETERINARY SCIENCE; METALLURGY; METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS INGENERAL; MICROBIOLOGY; MUTATION OR GENETIC ENGINEERING; PROCESSES OF PREPARING SUCH COMPOSITIONS; SPIRITS; VINEGAR; WINE

An article and method are provided for assessing the efficacy of a sterilization process. The article comprises an outer container having an interior volume; a dry source of measurable biological activity disposed in the interior volume; and an effective amount of a dry agent for neutralizing a sterilant compound; wherein both the source of measurable biological activity and the agent are in vapor communication with an environment outside the outer container. The method comprises exposing the article to a first sterilant and, optionally, a second sterilant for a period of time and detecting the measurable biological activity.