1.00550

Tryptic Soy Broth - Dehydrated Culture Media

GranuCult^® prime, EP, JP, USP, granular, from non-animal source, irradiated, suitable for aseptic process simulation

• Synonim(y): TSB, CASO, Casein Soybean Digest Broth, TSB non animal origin, SCDB, Tryptic Soy Broth non animal origin, CASO Broth, Casein Soya Broth, Soybean Casein digest Broth, TSB, Tryptone Soya Broth
• Numer MDL: MFCD00132536
• Kod UNSPSC: 41106200
• NACRES: NA.74

Właściwości

• pochodzenie biologiczne: non-animal source
• Poziom jakości: 400
• agency: EP; JP; USP
• sterylność: irradiated
• Postać: granular
• Właściwości: granulated
• opakowanie: pkg of 5 kg; pkg of 500 g
• producent / nazwa handlowa: GranuCult^® prime
• metody: media fill: suitable; microbiological culture: suitable
• pH: 7.1-7.5 (25 °C, 30 g/L in H₂O, after autoclaving)
• rozpuszczalność: 30 g/L
• Zastosowanie: aseptic process simulation; pharmaceutical
• kompatybilność: stand alone
• temp. przechowywania: 15-25°C
• przydatność: anaerobic bacteria

Opis

Opis ogólny

Dehydrated culture medium with vegetable peptones as a non-animal origin alternative to Soybean Casein Digest Medium (SCDM), also referred to as Tryptic Soy Broth. The Granulated media is cold filterable and irradiated for the microbiological validation of aseptic filling processes (media fill test or aseptic process simulation. The product is irradiated and triple-bagged allowing for safe introduction into controlled areas. Cold filterability is achieved by extensive testing comprising raw materials, pre-production samples, in-process and end product control. The formulation contains peptones of nonanimal origin instead of the recommended peptones.

Zastosowanie

The broth is suitable for Aseptic Process simulation (APS) according to the recommendations of the “FDA Aseptic Guide” and EU GMP Annex 1 in aseptic production lines. The exclusive use of raw materials of non-animal origin allows the elimination of a potential contamination risk with TSE/BSE.

Powiązanie

Replaces: 1.00550.5007

Inne uwagi

Mode of action: The microbiological performance of TSB non-animal origin is equivalent to the standard TSB. The dehydrated culture medium is irradiated. The intensity of irradiation guarantees that Bacteria, spores, viruses and mycoplasma are destroyed. It provides a higher level of security with regard to radiation-resistant microorganisms than other commercially available products.

Przypis

We offer two media types: the superior granulated GranuCult^® and the cost-efficient powdered NutriSelect^® culture media, depending on your needs.
The designations basic, plus, or prime are added to indicate the quality control level, from basic quality control to standard QC plus to prime for full regulatory compliance.

Informacje prawne

GRANUCULT is a registered trademark of Merck KGaA, Darmstadt, Germany

NutriSelect is a registered trademark of Merck KGaA, Darmstadt, Germany

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Informacja o środkach bezpieczeństwa

• Piktogramy: GHS07
• Hasło ostrzegawcze: Warning
• Zwroty wskazujące rodzaj zagrożenia: H317
• Zwroty wskazujące środki ostrożności: P261 - P272 - P280 - P302 + P352 - P333 + P313 - P362 + P364
• Klasyfikacja zagrożeń: Skin Sens. 1
• Kod klasy składowania: 11 - Combustible Solids
• Klasa zagrożenia wodnego (WGK): WGK 1