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Code 66091210

Biological indicators for autoclave sterilization

with spores of Geobacillus Stearothermophilus

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These biological indicators for sterilization are used for the routine control of the steam sterilization cycles and for the verification of the functionality of any type of steam autoclave.

The USP (United States Pharmacopoeia), EP (European Pharmacopoeia) and DAB (Deutsches Arzneibuch) standards recommend the use of bioindicators during the steam sterilization processes of drugs, medicines in vials, culture media, medical instruments and more.

The indicators are produced under strictly controlled conditions in order to meet the requirements indicated in the current edition of the USP and in accordance with the ISO 11138 and EN 866 standards.

The vials contain a nutritional broth, studied for the purpose, consisting of enzymatic digest of casein and soybeans, a pH indicator and a suspension of Geobacillus stearothermophilus spores (ATCC® 7953) in predefined concentrations:

E6 = 1-5x106 CFU / vial;

E5 = 1-5x105 CFU / vial;

E4 = 1-5x104 CFU / vial.

The spores of the microorganism are completely destroyed after 15 minutes of sterilization at 121 ° C and therefore during the next incubation they are not able to develop and change the color of the medium.

At a lower temperature or a shorter sterilization time, the spores partially survive and therefore during incubation they are able to develop and change the color of the medium.

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