1.00550

Tryptic Soy Broth - Dehydrated Culture Media

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

• 別名: CASOブロス, TSB, カゼインソーヤブロス, トリプトンソーヤブロス, 大豆カゼイン消化物ブロス
• MDL番号: MFCD00132536
• UNSPSCコード: 41106200
• NACRES: NA.74

特性

• 由来生物: non-animal source
• 品質水準: 400
• 認証: EP; JP; USP
• 無菌性: irradiated
• 形状: granular
• 特徴: granulated
• 包装: pkg of 5 kg; pkg of 500 g
• メーカー／製品名: GranuCult^® prime
• テクニック: media fill: suitable; microbiological culture: suitable
• pH: 7.1-7.5 (25 °C, 30 g/L in H₂O, after autoclaving)
• 溶解性: 30 g/L
• アプリケーション: aseptic process simulation; pharmaceutical
• 適合性: stand alone; anaerobic bacteria
• 保管温度: 15-25°C

詳細

詳細

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.

アプリケーション

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.

関連事項

Replaces: 1.00550.5007

その他情報

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.

脚注

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.

法的情報

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

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

安全性情報

• ピクトグラム: GHS07
• シグナルワード: Warning
• 危険有害性情報: H317
• 注意書き: P261 - P272 - P280 - P302 + P352 - P333 + P313 - P362 + P364
• 危険有害性の分類: Skin Sens. 1
• 保管分類コード: 11 - Combustible Solids
• WGK: WGK 1