1.10274
Sterikon® Plus Bioindicator
ampule of 2 mL, To monitor the effectiveness of the autoclaving by steam sterilization
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About This Item
UNSPSC Code:
42281526
NACRES:
NA.21
Recommended Products
Agency
EP
USP
Quality Level
form
liquid
feature
ready-to-use
packaging
ampule of 2 mL
application(s)
microbiology
storage temp.
2-8°C
suitability
Bacillus spp.
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.
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
Storage Class Code
12 - Non Combustible Liquids
WGK
WGK 1
Flash Point(F)
Not applicable
Flash Point(C)
Not applicable
Certificates of Analysis (COA)
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