Home / Biological indicators

Biological indicators (BI’s) are generally accepted as the most suitable device to use for monitoring sterilization processes on their effectiveness and the lethality of the used sterilizer. The BI’s contain a specific micro organism that is proven to be highly and stable resistant to the used sterilization process. The BI’s are used to assist in sterilization processes that render a product sterile in its final package or container, as well as for the sterilization of equipment, materials, and packaging components used in aseptic processing. Etigam BI’s are conventional spore growth readout indicators specifically designed for reliable monitoring of sterilization processes without the use of enzyme based technology or specific and specialized incubators or monitoring devices. Etigam NSS BI’s comply with the performance requirements of ANSI/AAMI/ISO 11138-1 and the USP requirements.

Home / Biological indicators

Spore Strips

Etigam biological sporestrips (NSS) are tradional and reliable indicators for the particular sterilization processes. These indicators consists of bacterial spores inoculated onto a paper filter carrier or disc contained within a glassine envelope. For usage the spore strip is removed from the load and aseptically transferred into appropriate microbiological culture medium. Biochemical activity of the micro organism produces acid by-products that, when transferred to standard broth, will demonstrate noticeable turbidity and in the case of using a culture media with pH indicator, the culture media will have a noticeable color change. Turbidity or a visual pH color change indicate a sterilization process failure.

Self-contained

Etigam self-contained biological indicators (NSC or NRI) are fast working reliable indicators for monitoring the particular sterilization processes. These indicators consist of a self-contained unit that includes bacterial spores inoculated onto a paper filter carrier and a small glass ampoule containing a nutrient broth culture medium as a pH indicator encased in a plastic vial that serves as the culture tube. When activated, biochemical activity of the micro organism produces acid by-products that cause the media to change color within the incubation time. A visual pH color change and/or turbidity indicates a sterilization process failure.

Spore Suspensions

Etigam spore suspensions are biological indicators to be used for direct inoculating on or into (representative) units of the product to be sterilized. The micro organism is added to a liquid substance containing 20% ethanol.

Miscellaneous

For the incubation of the NSC BI’s, preset incubators are available. These incubators have 15 slots for placing the BI’s and include a crushing well to enable the user to activate the BI’s.