Agency
EP
JP
USP
Quality Level
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
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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.
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.
WGK
WGK 1
Certificates of Analysis (COA)
Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.
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