1.00550

Tryptic Soy Broth - Dehydrated Culture Media

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

• Synonym(s): 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
• MDL number: MFCD00132536
• UNSPSC Code: 41106200
• NACRES: NA.74

Properties

• biological source: non-animal source
• Quality Level: 400
• Agency: EP; JP; USP
• sterility: irradiated
• form: granular
• feature: granulated
• packaging: pkg of 5 kg; pkg of 500 g
• manufacturer/tradename: GranuCult^® prime
• technique(s): media fill: suitable; microbiological culture: suitable
• pH: 7.1-7.5 (25 °C, 30 g/L in H₂O, after autoclaving)
• solubility: 30 g/L
• application(s): aseptic process simulation; pharmaceutical
• compatibility: stand alone
• storage temp.: 15-25°C
• suitability: anaerobic bacteria

Description

General description

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.

Application

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.

Linkage

Replaces: 1.00550.5007

Other Notes

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.

Footnote

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.

Legal Information

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

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

Safety Information

• Pictograms: GHS07
• Signal Word: Warning
• Hazard Statements: H317
• Precautionary Statements: P261 - P272 - P280 - P302 + P352 - P333 + P313 - P362 + P364
• Hazard Classifications: Skin Sens. 1
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 1