1.10274

Sterikon^® Plus Bioindicator

ampule of 2 mL, To monitor the effectiveness of the autoclaving by steam sterilization

• UNSPSC Code: 42281526
• NACRES: NA.21

Properties

• Agency: EP; USP
• Quality Level: 200
• form: liquid
• feature: ready-to-use
• packaging: ampule of 2 mL
• application(s): microbiology
• storage temp.: 2-8°C
• suitability: Bacillus spp.

Description

General description

The Sterikon^® plus Bioindicator contains a nutrient broth, sugar, a pH indicator, and spores of a non-pathogenic organism, Geobacillus stearothermophilus ATCC 7953 (sporulation optimized) in a single ampoule. The spores are completely killed upon heating in compressed steam at a temperature of 121 ± 0.5°C (245 kPa), after 15 minutes. At lower temperatures or lower exposure times, a small number of spores can survive at and can grow upon incubation. Sterikon^® ampoules are placed into the autoclave along with the batch to be autoclaved. The efficiency of the sterilization process is checked by the incubation of the ampoules. Red (or red-violet) color of the ampoule contents indicates no growth of Geobacillus stearothermophilus and adequate sterilization, whereas the yellow (or yellow-orange) color of the ampoule contents indicates growth and inadequate sterilization.

Application

Sterikon^® plus Bioindicator System is used to monitor the effectiveness of the autoclaving by steam sterilization for 15 minutes at 121°C. It is suitable for checking the sterilization efficiency of the culture media products used for testing of pharmaceuticals (especially drugs in ampoule form), food and water samples, along with canned foods and other products to be autoclaved.

Linkage

Replaces: 1.10274.0003

Analysis Note

Appearance: opalescent and reddish violet
Number of viable spores per ampoule: 5.0E+05 - 1.0E+07
Growth (35 °C): no growth
Growth (60 °C): growth
Performance test (6 min, 121 °C): Survival time 6 min/121 °C
Performance test (15 min, 121 °C): Kill time 15 min/121 °C
D value (121 °C): 1.5 - 2.0 min
Z value: 7.0 - 10.0 °C
Identity: Geobacillus stearo-thermophilus ATCC 7953
The determination of the D-value is based on the Stumbo-Murphy-Cochran method.
The identity control is carried out via MicroSeq-System.
Organism: Geobacillus stearothermophilus ATCC 7953 (sporulation optimized).
Ampoules: 2 ml.
Storage temperature: +2° to +8°C.

Legal Information

STERIKON is a registered trademark of Merck KGaA, Darmstadt, Germany

Safety Information

• Storage Class Code: 12 - Non Combustible Liquids
• WGK: WGK 1
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable