CHVE71TE3

ミリポアエクスプレス（Millipore Express）^®SHRP、カートリッジ

pore size 0.5/0.1 μm, cartridge nominal length 10 in. (25 cm), Code 7, EPDM rubber seal

• 別名: Millipore Express SHR Cartridge Filter 10 in. 0.5/0.1 μm Code 7 EPDM
• UNSPSCコード: 23151806
• eCl@ss: 32031690

特性

• 物質: EPDM rubber seal; polyethersulfone ; polypropylene ; polypropylene support; polysulfone
• 品質水準: 400
• 法規制遵守: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• 無菌性: non-sterile
• 滅菌適合性: autoclavable compatible; steam-in-place compatible
• 製品種目: Millipore Express^®
• 特徴: hydrophilic
• メーカー／製品名: Millipore Express^®
• パラメーター: ≤27.1 mL/min air diffusion at 3.45 bar (50 psig) and 23 °C (in water); <1.0 psi max. differential pressure (69 mbar) at 135 °C (reverse); 0.07 bar max. differential pressure (1 psi) at 135 °C (Reverse); 0.35 bar max. differential pressure (5 psi) at 135 °C (Forward); 1.7 bar max. differential pressure (25 psi) at 80 °C (Forward); 100 psi max. differential pressure (6.9 bar) at 25 °C (forward); 15 psi max. differential pressure (1.0 bar) at 135 °C (forward); 2.07 bar max. differential pressure (30 psi) at 25 °C (Reverse); 25 psi max. differential pressure (1.7 bar) at 80 °C (forward); 30 psi max. differential pressure (2.1 bar) at 25 °C (reverse); 6.9 bar max. differential pressure (100 psi) at 25 °C (Forward)
• テクニック: sterile filtration: suitable
• L: 10 in.
• W: 2.7 in.
• カートリッジの長さ（公称）: 10 in. (25 cm)
• 直径: 6.9 cm (2.7 in.)
• ろ過面積: 0.48 m²
• 不純物: ≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• マトリックス: Millipore Express^® SHR (w/Prefilter)
• pore size: 0.5/0.1 μm pore size
• 入力: sample type liquid
• 泡立ち点: ≥2586 mbar (37.5 psig), nitrogen with 70/30% IPA/water at 23 °C
• カートリッジコード: Code 7

詳細

詳細

Device Configuration: カートリッジ

包装

ダブル　イージーオープン　バッグ

その他情報

これらの製品はFDAの定めたGMP準拠の製造工場で製造されています。

Directions for Use

• Organism Retention: Microorganism
• Mode of Action: Filtration (size exclusion)
• Application: BioProcessing
• Intended Use: Reduction or removal of microorganism/bioburden
• Instructions for Use: Please refer wetting instructions of Filters with MILLIPORE EXPRESS^® Membrane user guide
• Storage Statement: Please refer Filters with MILLIPORE EXPRESS^® Membrane user guide
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

調製ノート

Sterilization Method
135 °C - 30分のSIP 正方向サイクルを25回、または正方向サイクルを22回及び逆方向サイクルを3回、または100.0 kPa (15 psid)以下で135 °C - 30分の正方向サイクルを3回; 126 °C －60分のオートクレーブ滅菌サイクルを25回

This product was manufactured with a Millipore Express^® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

アナリシスノート

Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM^® F838 methodology.

次の水でフラッシング後USP Oxidizable Substances Testに適合 ≥2 L

TOC/Conductivity
After sterilization and a controlled water flush of 20 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.

法的情報

ASTM is a registered trademark of American Society for Testing and Materials

MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany