Spore Strip Reduced Incubation Time
The Spore Strip Reduced Incubation Time test validates a reduction in incubation time for biological indicators (BIs) used in sterilization cycles. This study is applicable to any type of BI made commercially and can be used on any sterilization process including steam, ethylene oxide, dry heat and vaporized hydrogen peroxide. This test provides the manufacturer with data to support the release of product earlier than 7 days with a full BI incubation period.
All testing is performed as outlined in FDA’s Guide for Validation of Biological Indicator Incubation Time CRD040. A draft ISO standard is also in process and will be implemented upon document approval and publication. Nelson Laboratories qualified personnel have extensive experience in performing incubation reduction studies. The use of BI Evaluation Resistometer (BIER) vessels provides “square wave” cycles for tight, accurate parameters and immediate testing of samples following cycle completion.
- ISO 11135
- ISO 17655
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|RIT110||Spore Strip Incubation Time Reduction (RIT), CDRH, 100% EO (6 cyc)||Add|
|RIT120||Spore Strip Incubation Time Reduction (RIT), CDRH, 100% EO, add. cycles||Add|
RIT110 - Spore Strip Incubation Time Reduction (RIT), CDRH, 100% EO (6 cyc)
RIT120 - Spore Strip Incubation Time Reduction (RIT), CDRH, 100% EO, add. cycles
RIT110: 500 BIs per lot; 3 lots required
Study OutlineThe Spore Strip Reduced Incubation Time test consists of exposing three separate lots of 100 BIs from a single manufacturer to a fractional exposure cycle. The validation can be done on any commercially made BI, on any type of carrier, both self-contained or on a strip.
R&D fractional interval exposure cycles are performed using specifc sterilization parameters to find the time that results in fractional growth used for the exposure of the 100 BIs. For EO, the temperature, relative humidity and gas concentration will remain consistent for each cycle.
BIs are scored for growth at 24-hour intervals for 7 days. The number of BIs which grow by the 7th day must be between 30 and 80 of the total 100 exposed. The absolute number that grows by the 7th day is defined as 100%. The percent of BIs that grow after each day will then be calculated. The first day which demonstrates 97.0% or greater growth of the BIs will be considered the validated incubation interval.