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Thermo Scientific™ Caldo de triptona de soja filtrable en frío (deshidratado)

Realice ensayos de llenado de medios (MFT) microbiológicos en el sector farmacéutico con este medio con radiación gamma.

Marca:  Thermo Scientific™ CM1065R

Detalles adicionales : Peso : 0.01000kg

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Código de producto. 12570836

  • 659.00€ / 3 Kg

Fecha estimada de envío
12-03-2021

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Descripción

Descripción

Realice ensayos de llenado de medios (MFT) microbiológicos en el sector farmacéutico con el caldo de triptona de soja con radiación gamma y filtrable en frío Thermo Scientific™ Oxoid™ (deshidratado). El medio muy nutritivo para uso general respeta la formulación para MFT establecida en las farmacopeas europea1, británica2, estadounidense3 y japonesa4.

El caldo de triptona de soja filtrable en frío se puede sustituir por los componentes en polvo que se utilizan en la creación de fármacos acuosos para proporcionar un índice del nivel de contaminación microbiana que se produce en la fabricación aséptica.

‘Sterile for use’ liquid drugs often contain heat-sensitive components which means that terminal sterilisation by autoclaving is not an option. Sterilisation by filtering (for soluble liquids) followed by filling under aseptic conditions is the method for preparation of these types of drug. The purpose of Media Fill Trials is to provide a measure of the likelihood of microbiological contamination arising in a particular aseptic process.

Packs of Cold Filterable Tryptone Soya Broth have been given a sterilizing dose of gamma-irradiation (minimum 25KGy) validated as a lethal dose for all yeasts, molds, bacterial spores and mycoplasma.

  • Gamma-irradiated to ensure that the medium is free from all yeasts, moulds, and bacteria, including bacterial spores and mycoplasmas, prior to use.
  • Screened and selected to ensure a highly filterable solution that has a known Vcap value. This allows the maximum filterable volume to be calculated before starting a MFT.

The purpose of MFT is to provide a measure of the likelihood of microbiological contamination occurring in a particular aseptic process. Cold Filterable TSB can be used as a substitute for filter-sterilized drug products and is processed in a manner identical to that in which the product would be processed i.e. filtering, filling and closing. The medium is then incubated and the number of contaminated units is scored versus those that are un-contaminated. A decision following pre-determined guidelines can be made based on the proportion of contaminated units and the identity of the microorganisms recovered5.

Cold Filterable Tryptone Soya Broth may also be used to test aseptic production processes for solid presentations by adding the medium as a sterile liquid downstream of processing a placebo5.

For laboratory use, standard Thermo Scientific™ Oxoid™ Tryptone Soya Broth (CM0129) may be more appropriate.

Not all products are available for sale in all territories. Please inquire.

Remel™ and Oxoid™ products are now part of the Thermo Scientific brand

Especificaciones

Especificaciones

Cold Filterable Tryptone Soya Broth
Broth, Media
2.5 kg
Each
Dehydrated Culture Media
For 16.7 L mediµm
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