Description
Classification
Class 1, according to risk (ANMAT).
Characteristics
- 10^6 Geobacillus stearothermophilus ATCC®* 7953 spores per strip.
- 25 mm x 70 mm non-absorbent material package.
- Brown code. 5 mm x 25 mm filter paper strip.
- Monitoring 121-135 °C steam and formaldehyde sterilization processes.
- Upon completion of the sterilization cycle, the spore strip should be tested in a suitable culture medium.
- Terragene S.A. suggests the use of Bionova® MC1020-2 culture medium. Incubation conditions: 24 hours, between 55-62 °C for steam sterilization processes.
- 48 hours, between 55-62 °C for formaldehyde sterilization processes.
- For conventional culture media like TSB, incubation for 7 days between 55-62 °C is recommended.
- D-ValueSTEAM: Not lower than 1.5 min.
- Conditions: 121 °C. Z-ValueSTEAM: Not lower than 6 °C.
- D-ValueFORM: Not lower than 6.0 min. Conditions: 60 °C, 1 mol/l formaldehyde. Environmental conditions during manufacture T = 15-30 °C, RH = 30-80 %.
- Sterility conditions are necessar only during the inoculation process performed in laminar flow. Storage conditions T = 10-30 °C, RH = 30-80 %.
- Transport conditions Storage conditions should be followed.







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