1.00800

Tryptic Soy Broth - Dehydrated Culture Media

GranuCult^® prime, EP, JP, USP, granular, irradiated, suitable for aseptic process simulation

• Synonym(s): Casein-Peptone soymeal-peptone broth, Soybean casein digest broth, TSB, CASO, Casein Soybean Digest Broth, Tryptic Soy Broth, Tryptone Soya Broth, SCDB, CASO Broth, Casein Soya Broth, Soybean Casein digest Broth, TSB, Tryptone Soya Broth
• MDL number: MFCD00132536
• UNSPSC Code: 41106200
• NACRES: NA.74

Properties

• Agency: EP; JP; USP
• Quality Level: 400
• 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
• solubility: 30 g/L
• bulk density: 570 kg/m³
• application(s): aseptic process simulation; pharmaceutical
• compatibility: stand alone
• storage temp.: 15-25°C
• suitability: anaerobic bacteria

Description

General description

The Granulated media is cold filterable and irradiated for the microbiological validation of aseptic filling processes (Media fill test or aseptic process simulation). The media are supplied in triple-wrapped and cleanroom ready for the ultimate security of aseptic process. It is granulated which guarantees excellent solubility even in cold water. Cold filterability is achieved by extensive testing comprising raw materials, pre-production samples, in-process and end product control

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. Due to the rich nutrient base, this medium is also suitable for the cultivation of even fastidious microorganisms. These liquid medium finds its application in pharmaceutical industry.

Linkage

Replaces: 1008005007

Other Notes

Mode of action: 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

• WGK: WGK 1