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1.10274

Sterikon® Plus Bioindicator

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

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15 amp
Please contact Customer Service for Availability
PLN 261.00
100 amp
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PLN 1,660.00

About This Item

NACRES:
NA.21
UNSPSC Code:
42281526

PLN 261.00


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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.

Other Notes

Replaces: 1.10274.0003

Legal Information

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

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This Item
1.114991.038631.03879
feature

ready-to-use

feature

ready-to-use

feature

-

feature

-

packaging

ampule of 2 mL

packaging

-

packaging

-

packaging

-

storage temp.

2-8°C

storage temp.

2-8°C

storage temp.

-

storage temp.

15-25°C

form

liquid

form

liquid (ready-to-use)

form

powder

form

powder

Quality Level

200

Quality Level

200

Quality Level

200

Quality Level

200

agency

EP, USP

agency

EP, USP

agency

-

agency

-


Storage Class

12 - Non Combustible Liquids

wgk

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable



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Questions

  1. I need to know the recommended tolerance for bioindicator checks related to incubation duration. best regard

    1 answer
    1. 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

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