Biological indicator sterility test
The number of BIs should be based on ISO/EN recommendations regarding usable chamber volume of the sterilizer or product load size (proposed under new revision of ISO11135). Contact Nelson Laboratories for details. Please notify the laboratory when weekend delivery of biological indicators is expected. Studies that come in over the weekends will be charged STAT pricing. Specific courier and tracking information is appreciated.
A minimum report fee of $100.00 applies to BI sterility tests (standard BIs).
A minimum report fee of $75.00 applies to BI sterility tests (self-contained BIs).
Optional Tests for Biological indicator sterility test
Spore strip reduced incubation time validation
The biological indicator (BI) incubation reduction validation provides the manufacturer with data to support the release of product earlier than permitted with a full BI incubation period. This study outline describes the validation of a reduced incubation time for BIs used in industrial ethylene oxide sterilization cycles. The validation concept consists of exposing three separate lots of 100 BIs from a single manufacturer to fractional ethylene oxide (EO) exposure cycles. The validation can be done on any BI, either commercially made or in house, on any type of carrier, both self contained or on a strip.
Biological indicator population verification; one species USP 55
A population verification test is used to determine the number of spores on a biological indicator. This test is routinely performed on incoming BI shipments to verify the population meets specification before use. Three BIs are pooled for each test. Please include the BI organism and expected titer (ex, Bacillus atrophaeus 10 E6).
