LAHL04PP6

Optiseal Durapore 筒式过滤器 0.45 µm

filtration area 0.18 m², matrix Durapore^®

• 别名: Optiseal^® 滤芯过滤器 Durapore^®
• 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
• 法律遵循: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• 無菌: non-sterile
• 滅菌相容性: autoclavable compatible; steam-in-place compatible
• 產品線: OptiSeal^®
• 特點: hydrophilic
• 製造商／商標名: OptiSeal^®
• 參數: ≤4 mL/min air diffusion at 1.5 bar (22 psig) and 23 °C (in water); 0.35 bar max. differential pressure (5 psid) at 121 °C (Forward); 0.35 bar max. inlet pressure (5 psi) at 121 °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: bioburden reduction: 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^®
• 輸入: sample type liquid
• 起泡點: ≥1930 mbar (28 psig), air with 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

Gravimetric Extractables: after 24 hours in water at controlled room temperature

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥500 mL

法律資訊

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

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