48 hours has been validated as the shortest time required for a successful Sterikon incubation. Up to 7 days is validated as can be seen in the Application note: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/product/documents/588/304/sterikon-plus-incubation-time-an1800en-ms.pdf
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
NACRES:
NA.21
UNSPSC Code:
42281526
Pricing and availability is not currently available.
Quality Segment
agency
EP, USP
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.
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.
Other Notes
Replaces: 1.10274.0003
Legal Information
STERIKON is a registered trademark of Merck KGaA, Darmstadt, Germany
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This Item | |||
|---|---|---|---|
| feature ready-to-use | feature ready-to-use | feature - | feature - |
| packaging ampule of 2 mL | packaging - | packaging - | packaging - |
| agency EP, USP | agency EP, USP | agency - | agency - |
| application(s) microbiology | application(s) food and beverages, microbiology | application(s) food and beverages | application(s) food and beverages |
| suitability Bacillus spp. | suitability Bacillus geobacillus | suitability nonselective for anaerobic bacteria: Clostridium spp. | suitability Enterococcus spp., Haemophilus spp., Pneumococcus spp., Staphylococcus spp., Streptococcus spp. |
| form liquid | form liquid (ready-to-use) | form powder | form powder |
Storage Class
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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Global Trade Item Number
| SKU | GTIN |
|---|---|
| 1102740001 | 04022536123295 |
| 1102740002 | 04022536123301 |
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I need to know the recommended tolerance for bioindicator checks related to incubation duration. best regard
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