LAGR04TP6

エアベント^® 0.2 µm、Optiseal^®カートリッジ

pore size 0.2 μm, OptiSeal^® 4 in., filtration area 0.18 m², matrix Aervent^®

• 別名: Optiseal Aervent Cartridge Filter 0.2 µm hydrophobic
• UNSPSCコード: 23151806
• eCl@ss: 32031690

特性

• 物質: PTFE ; polypropylene ; polypropylene support; silicone seal
• 品質水準: 400
• 無菌性: non-sterile
• 滅菌適合性: steam-in-place compatible
• 製品種目: OptiSeal^® 4 in.
• 特徴: hydrophobic
• メーカー／製品名: OptiSeal^®
• パラメーター: ≤6 mL/min nitrogen diffusion at 965 mbar (14 psig) and 23 °C (in 70/30% IPA/water); 0.35 bar max. differential pressure (5 psid) at 135 °C (Forward); 0.35 bar max. inlet pressure (5 psi) at 135 °C (Forward); 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward); 1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward); 4.1 bar max. differential pressure (60 psid) (Reverse); 4.1 bar max. inlet pressure (60 psi) (Reverse;); 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward); 5.5 bar max. inlet pressure (80 psi) at 25 °C (Forward)
• テクニック: gas filtration: suitable
• L: 4 in.
• カートリッジの長さ（公称）: 4 in. (10 cm)
• ろ過面積: 0.18 m²
• 不純物: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• 重量分析抽出物: ≤10 mg/cartridge
• マトリックス: Aervent^®
• ポアサイズ: 0.2 μm pore size
• 入力: sample type liquid
• 泡立ち点: ≥1100 mbar (16 psig), nitrogen with 70/30% IPA/water at 23 °C
• カートリッジコード: not applicable

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 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.

調製ノート

Sterilization Method
135 °C 30 分のSIP 80回 (正方向 40回/逆方向 40回) ; 135 °C 30 分のオートクレーブ滅菌 80回

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: ≤0.20 mL/min with water @ 2.6 bar (38 psig)

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

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

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