KTGRA10HH1

Aervent^® 0.2 µm、オプティキャップ（Opticap）^® XLカプセル

Opticap^® XL 10, inlet connection diam. 9/16 in., pore size 0.2 μm, cartridge nominal length 10 in. (25 cm)

• 別名: Aervent KTGR Opticap XL10 Capsule
• UNSPSCコード: 23151806
• eCl@ss: 32031690

特性

• 物質: PTFE ; polypropylene ; polypropylene housing; polypropylene support; polypropylene vent cap; silicone seal
• 品質水準: 400
• 無菌性: non-sterile
• 滅菌適合性: autoclavable compatible
• 製品種目: Opticap^® XL 10
• 特徴: hydrophobic
• メーカー／製品名: Aervent^®
• パラメーター: ≤24 mL/min nitrogen diffusion at 970 mbar (14 psig) and 23 °C (in 70/30% IPA/water); 1.0 bar max. differential pressure (15 psid) at 80 °C (Forward); 1.0 bar max. inlet pressure (15 psi) at 80 °C (Forward); 2.8 bar max. inlet pressure (40 psi) at 60 °C (Forward); 25 °C max. inlet temp.; 4.1 bar max. differential pressure (60 psid) (Reverse; intermittent); 4.1 bar max. inlet pressure (60 psi) (Reverse; Intermittent); 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward); 5.5 bar max. inlet pressure (80 psi) at 25 °C (Forward); 80 psig max. inlet pressure
• テクニック: gas filtration: suitable
• L: 13.2 in.
• W: 4.2 in.
• カートリッジの長さ（公称）: 10 in. (25 cm)
• 直径: 10.7 cm (4.2 in.)
• ろ過面積: 0.65 m²
• 入口接続部直径: 9/16 in.
• 入口幅・出口幅: 33.3 cm (13.1 in.)
• 出口接続部直径: 9/16 in.
• 不純物: <0.25 EU/mL USP bacterial endotoxins (LAL test, aqueous extraction)
• 重量分析抽出物: ≤45 mg/cartridge
• マトリックス: Aervent^®
• ポアサイズ: 0.2 μm pore size
• 入力: sample type gas
• 泡立ち点: ≥1100 mbar (16 psig), nitrogen with 70/30% IPA/water at 23 °C
• フィッティング: 1/4 in. drain/vent hose barb (with double O-ring Seal); inlet hose barb; outlet hose barb; (14 mm (9/16 in.) Hose Barb Inlet and Outlet)

詳細

詳細

Device Configuration: カプセル

特徴および利点

Rated for aerosol retention of a total challenge of 108–1010 plaque forming units of ΦX-174 virus particles at 85 Nm3/h (50 SCFM) per cartridge.

包装

ダブル イージーオープン バッグ

品質

Retains Brevundimonas diminuta liquid aerosol for 21 days at a minimum challenge of 10⁷ CFU/cm²

調製ノート

Sterilization Method
135 °C 30 分のオートクレーブ滅菌30回; インライン蒸気滅菌不可

This product was manufactured with a PTFE 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.

HydroCorr: ≤0.75 mL/min @ 2.6 bar (38 psig) per sample

Gravimetric Extractables: after 24 hours in a 70/30% IPA/water mixture at controlled room temperature

その他情報

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 Steam Sterilization & Integrity Testing Procedures guide and first page of Visual Inspection Guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

法的情報

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

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

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

免責事項

EMD Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 2014/68/EU of 15 May 2014. This product has been classified under Article 4 § 3 of the Directive 2014/68/EU. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 4 § 3 of the Directive 2014/68/EU, this product does not bear the CE mark.