The ampoules are available in two sizes with either 1.5 ml or 0.2 ml Geobacillus stearothermophilus suspension with growth medium and pH indicator. Populations of Geobacillus stearothermophilus are available with 105 or 106 Colony Forming Units (CFU). Following completion of the sterilisation process, the glass ampoules are incubated.
If a proportion of the spores survived the process, the germs replicate and produce acids, which results in a change in the pH of the liquid and hence a colour change from purple to yellow. A successful process is indicated when the ampoule remains purple.
The Stearo Ampoules are produced in accordance with EN ISO 11138-1 and 3, as well as the current European and United States Pharmacopoeia. Population and D-value are measured and certified for each batch which is documented in the certificate enclosed in the package.
The gke Stearo-Ampoules can be used for sterilisation monitoring of liquids in glass bottles or solid materials.
Steam sterilisation, liquid sterilisation, microwaves or mixtures of all can be monitored at 110 – 134ºC with corresponding sterilisation times. The Stearo Ampoules are especially suitable for waste sterilisation. Only dry heat sterilisation may not be monitored with the Stearo Ampoules.
The ampoules are to be placed in the area considered most difficult to sterilize – directly in liquids or in the centre of packs.
- Stearo Ampoules are produced according to the actually EN ISO standards and the Euro-pean and United States Pharmacopoeia.
- Each batch contains a certificate which represents a data analysis of population and D-value under precisely defined conditions of sterilisation.
- Guaranteed stability of 12 months from production.
- Continuous quality monitoring of each batch according to the quality criteria according to EN ISO 13485.
- Mini ampoules available to test sterility inside of small packs (e.g. eye lenses)
- Rapid incubation by optimisation of growth medium with a pH indicator.
- No negative control necessary (details see technical information TI 155)
Dry Bath Incubator
The gke incubator is temperature and time programmable. The incubation temperature is visible on the LCD display.
|B225-550||Stearo Ampoules, G. Stearothermophilus 105 – 11 x 45mm (50 pack)||50|
|B225-650||Stearo Ampoules, G. Stearothermophilus 106 – 11 x 45mm (50 pack)||50|
|B235-510||Mini Stearo Ampoules, G. stearothermophilus 105 – 5 x 25mm (100 pack)||100|
|B325-610||Mini Stearo Ampoules, G. stearothermophilus 106 – 5 x 25mm (100 pack)||100|
|B610-112||Variable temperature selection and programming of the incubation time||1|
|B610-114||Aluminum block for gke Steri-Record® Standard Stearo ampoules||1|