Solubility : 30 g/l
pH : 7.1 - 7.5 (30 g/l, H₂O, 25°C) (after autoclaving)
Shipped in ambient
Storage temp.: Store at +15°C to +25°C.
Specifications :
Appearance
- clearness : clear
- colour: yellowish brown
pH-value (25°C): 7.1 - 7.5
Stability test (7 days, room temperature): clear
Sterility
- 2 weeks at 20-25°C : no growth
- 2 weeks at 30-35°C: no growth
mycoplasma (qPCR): negative post sterility testing
Minimum irridation dose: ≥ 48 kGy
Maximum irridation dose: ≤ 76 kGy
Growth promotion test in accordance with the harmonised method of EP and USP
Inoculum on reference medium
- Escherichia coli ATCC 8739 (WDCM 00012) : 10 - 100
- Staphylococcus aureus ATCC 6538 (WDCM 00032): 10 - 100
- Staphylococcus aureus ATCC 25923 (WDCM 00034): 10 - 100
- Staphylococcus epidermidis ATCC 12228 (WDCM 00036): 10 - 100
- Streptococcus pneumoniae ATCC 6301: 10 - 100
- Bacillus subtilis ATCC 6633 (WDCM 00003): 10 - 100
- Candida albicans ATCC 2091 (WDCM 00055): 10 - 100
- Candida albicans ATCC 10231 (WDCM 00054): 10 - 100
- Aspergillus brasiliensis (formerly A. niger) ATCC 16404 (WDCM 00053): 10 - 100
- Pseudomonas aeruginosa ATCC 9027 (WDCM 00026): 10 - 100
- Salmonella typhimurium ATCC 14028 (WDCM 00031): 10 - 100
Reference medium: Tryptic Soy Agar (Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Bacillus subtilis, Pseudomonas aeruginosa, Salmonella typhimurium, Staphylococcus epidermidis), SABOURAUD-2%-Glucose Agar (Candida albicans, Aspergillus brasiliensis)
Growth / 24h at 30-35°C
- Escherichia coli ATCC 8739 (WDCM 00012) : visible growth
- Staphylococcus aureus ATCC 6538 (WDCM 00032): visible growth
- Streptococcus pneumoniae ATCC 6301: visible growth
- Bacillus subtilis ATCC 6633 (WDCM 00003): visible growth
- Pseudomonas aeruginosa ATCC 9027 (WDCM 00026): visible growth
- Salmonella typhimurium ATCC 14028 (WDCM 00031): visible growth
Growth / 3 days at 20-25°C
- Staphylococcus aureus ATCC 6538 (WDCM 00032): visible growth
- Staphylococcus aureus ATCC 25923 (WDCM 00034): visible growth
- Staphylococcus epidermidis ATCC 12228 (WDCM 00036): visible growth
- Bacillus subtilis ATCC 6633 (WDCM 00003): visible growth
Growth / 5 days at 20-25°C
- Candida albicans ATCC 2091 (WDCM 00055): visible growth
- Candida albicans ATCC 10231 (WDCM 00054): visible growth
- Aspergillus brasiliensis (formerly A. niger) ATCC 16404 (WDCM 00053): visible growth
Typical composition (g/litre): Peptone non animal origin 20. 0; D(+)-Glucose monohydrate 2.5; Sodium chloride 5.0; di-Potassium hydrogen phosphate 2.5.
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True safety
Accurate and convenient media fill trials False results due to low-quality culture media are a major concern in media fill trials. With the robust validated process of Merck Millipore’s high-quality broths, you can eliminate media-related positives from your aseptic process simulation. Our stringent sterilization process inactivates all viable bacteria, yeast, mold, spores, and mycoplasma.
Merck Millipore’s granulated and liquid media are both available as either Tryptic Soy Broth (TSB) or non-animal Vegetable Peptone Broth (VPB). Simply choose the format that suits your needs:
• Dehydrated culture media: Gamma-irradiated ; highly soluble and filterable in low-dust granulated form ; triple-wrapped for secure cleanroom use.
- Ready-to-use liquid broth: Supplied triple-wrapped in gas-impermeable bags for aseptic connections ; direct link to production vessels and delivery systems
Top standards / Internationally compliant quality – unconcerned by BSE
Whether vegetable- or animal-based, every batch of our culture media is produced and tested in compliance with stringent international standards. For additional security, Merck Millipore sources all concerned bovine ingredients exclusively from countries classified by the OIE as negligible risk countries.
• EU Note for Guidance (EMA/410/01 Rev. 03) aimed at minimizing the risk of infection from animal spongiform encephalopathy via pharmaceutical products
• USDA standards for validation of aseptic preparations
• All culture media with bovine peptones already comply with the future EU Directive on minimizing the risk of BSE from products of animal origin
Total confidence / Comprehensive documentation
Detailed documentation is available for every culture medium we supply. Not only does this support critical attributes of your aseptic process simulation, it also simplifies your audits.
• BSE/T SE certificates provide full traceability of all animal-derived material and facilitate compliance with requirements
• Quality agreements with suppliers ensure the consistent quality of our products
• Certificates of Analysis include detailed information about each product, such as actual results obtained from quality control testing
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Granulated Culture Media / Minimal dust, maximum security and performance
Merck Millipore’s granulated culture media have been carefully formulated to ensure pharmaceutical manufacturers can perform efficient media fill trials with minimal risks.
• Reduced dust spread during preparation lowers health risks and prevents environmental contamination. Less dust on equipment also eases handling and cleaning.
• Excellent solubility significantly reduces preparation time and effort.
• Optimized cold filtration properties, from raw materials to final product, help prolong filter life and reduce replacements, saving time and costs.
• Gamma-irradiated at a high dose of 48-76 kGy to reduce microbial cross-contamination and risk of false positives due to irradiation survivals.
• Growth promotion and sterility performance in compliance with harmonized pharmacopeia and ISO EN 11133 guidelines regarding production and performance testing.
Granulated Culture Media / Optimized cold-filtration avoids clogs and costs
Most aseptic filling processes involve a sterile filtration step, which is typically part of the process simulation with culture media. The large amounts of liquid running through the filters make this step both time-consuming and expensive. This is of particular concern when problems, such as clogs, occur.
To avoid such challenges, Merck Millipore takes every measure to ensure the reliable cold-filtration properties of its granulated culture media. Filtration tests are performed at every stage and for every batch:
• Qualification of raw materials
• Control of incoming peptones
• Pre-batch samples and in-process testing
• End product testing
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