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Merck

1.00550

Tryptic Soy Broth - Dehydrated Culture Media

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

동의어(들):

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

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UNSPSC Code:
41106200
NACRES:
NA.74
MDL number:
Manufacturer/tradename:
GranuCult® prime
Agency:
EP, JP, USP
Ph:
7.1-7.5 (25 °C, 30 g/L in H2O)
Form:
granular
Suitability:
anaerobic bacteria
Application(s):
aseptic process simulation, pharmaceutical
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biological source

non-animal source

Quality Segment

agency

EP, JP, USP

sterility

irradiated

form

granular

feature

granulated

packaging

pkg of 10 kg, 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)

solubility

30 g/L

application(s)

aseptic process simulation, pharmaceutical

compatibility

stand alone

storage temp.

15-25°C

suitability

anaerobic bacteria

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.

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.
Replaces: 1.00550.5007

Legal Information

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

Disclaimer

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.


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Warning

hcodes

Hazard Classifications

Skin Sens. 1

저장 등급

11 - Combustible Solids

wgk

WGK 1



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