Tag: BactoCount

Extension certificates Bentley Instruments BactoCount IBC 3.0 & BactoCount IBCm 3.0 issued

MicroVal certified an extension study for the Bentley Instruments BactoCount IBC 3.0 & BactoCount IBCm 3.0 devices. These devices measure total bacterial count (TBC) and somatic cell count (SCC). Initially validated in 2022 for raw cow’s milk, they are now certified for raw goat’s and sheep’s milk as well. Both validation studies were conducted by ACTALIA Cecalait.

The BactoCount IBC 3.0 & BactoCount IBCm 3.0 can offer simultaneous real-time analysis of TBC and SCC in raw milk with a flow cytometer, but in the frame of this validation, TBC and SCC were tested separately. The validation scope covers only the separate use of TBC and SCC.

The extension studies were done according to ISO 16297, ISO 21187, and ISO 16140-2 for TBC and according to ISO 8196-3, ISO 13366-2, and ISO 16140-2 for SCC, using ISO 4833-1 and ISO 133366-1 as reference methods. Results obtained for TBC were also compared with the limits defined in the EU-RL document. The programs used to analyze sheep’s and goat’s milk are the same as for cow milk (ratio milk/reagent, type of reagent, incubation time, and protocol).

Both certificates 2021LR97 and 2021LR98 can be found on our website.

New Certificate for BactoCount IBC 3.0 and IBCm 3.0

MicroVal has approved the issuing of the certificates for Bentley’s BactoCount IBC 3.0 and BactoCount IBCm 3.0. ACTALIA Cecalait carried out the validation study for the enumeration of somatic cells and total bacterial count for the scope of raw cow’s milk.

The BactoCount IBC 3.0 and BactoCount IBCm 3.0 are fully automatic instruments that implement flow cytometry for a real-time  and accurate analysis of total flora and somatic cells in raw milk. Although both instruments can run the analysis for somatic cell count and total bacteria count simultaneously, for this validation both applications were tested separately.

The results of the validation, performed according to the ISO 16140:2:2016, demonstrate that the performance characteristics of both instruments for the enumeration of somatic cell count comply with the values specified in ISO 8196-3 / IDF 128-3. Based on the ISO 13366-1: 2008, both BactoCount instruments were compared and revealed at least equivalent with the SomaCount FC as the reference method.

For total bacterial count, the validation also resulted in compliance of the performance characteristics with the values defined in ISO 16297. Based on the ISO 4833-1: 2013, the comparison study with the BactoCount 2.0 as the reference method revealed at least equivalent and is approved as compliant with the criteria of the EURL MMP document for enumeration of total flora (2011).

The certificates and the accompanying summary reports, number 2021LR97 for BactoCount IBC 3.0 and number 2021LR98 for BactoCount IBCm 3.0, can be found under ‘issued certificates / alternative methods’.