LAGB04TP6

Optiseal Durapore 筒式过滤器 0.22 µm 疏水性

pore size 0.22 μm, OptiSeal^® 4 in., filtration area 0.18 m², matrix Durapore^®

• 别名: Durapore^® 0.22 µm, Optiseal^® 滤芯
• 分類程式碼代碼: 23151806
• eCl@ss: 32031690

属性

• 材料: PVDF ; polypropylene ; polypropylene support; silicone seal
• 品質等級: 400
• 無菌: non-sterile
• 滅菌相容性: steam-in-place compatible; steam-in-place compatible
• 產品線: OptiSeal^® 4 in.
• 特點: hydrophobic
• 製造商／商標名: OptiSeal^®
• 參數: ≤2 mL/min nitrogen diffusion at 1.0 bar (15 psig) and 23 °C (in 60/40% IPA/water); 0.35 bar max. differential pressure (5 psid) at 121 °C (Forward); 0.35 bar max. inlet pressure (5 psi) at 135 °C (Forward); 3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse); 3.5 bar max. differential pressure (50 psid) at 80 °C (Forward); 3.5 bar max. inlet pressure (50 psi) at 25 °C (Reverse); 3.5 bar max. inlet pressure (50 psi) at 80 °C (Forward); 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward); 5.5 bar max. inlet pressure (80 psi) at 25 °C (Forward)
• 技術: sterile filtration: suitable
• 長度: 4 in.
• 柱標稱長度: 4 in. (10 cm)
• 過濾面積: 0.18 m²
• 雜質: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• 重量法萃取物: ≤10 mg/cartridge
• 基質: Durapore^®
• 孔徑: 0.22 μm pore size
• 輸入: sample type liquid
• 起泡點: ≥1240 mbar (18 psig), nitrogen with 60/40% IPA/water at 23 °C
• 柱代碼: not applicable

说明

一般說明

Device Configuration: Cartridge

包裝

Double Easy-Open bag

其他說明

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

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 for Filter Units with Durapore^® Membrane user guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

準備報告

Sterilization Method
30 SIP cycles of 30 min @ 135 °C; 10 autoclave cycles of 30 min @ 126 °C

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

分析報告

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

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

法律資訊

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

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

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