KEGBG003FF3

Millipore Express^® SPG 0.2 µm，Opticap^® XL囊式过滤器

Opticap^® XL 300, inlet connection diam. 3/4 in., pore size 0.2 μm

• 别名: Gamma Phobic Opticap^® XL 300 Express SPG 0.2 sanitary flange
• 分類程式碼代碼: 23151806
• eCl@ss: 32031690
• NACRES: NB.24

属性

• 材料: polyethersulfone membrane; polyethylene support; polypropylene (gamma-stable); polypropylene housing; polypropylene vent cap; polysulfone ; silicone seal
• 品質等級: 400
• 無菌: irradiated; non-sterile
• 滅菌相容性: gamma compatible
• 產品線: Opticap^® XL 300
• 特點: hydrophobic
• 製造商／商標名: Opticap^®
• 參數: 2.1 bar max. differential pressure (30 psid) at 25 °C (Reverse; intermittent); 25 °C max. inlet temp.; 4.1 bar max. inlet pressure (60 psi) at 23 °C; 4.2 bar max. differential pressure (60 psid) at 25 °C (Forward); 60 psi max. differential pressure (4.1 bar) (continuous); 60 psig max. inlet pressure
• 技術: gas filtration: suitable
• 長度: 11.9 cm (4.7 in.)
• 直徑: 5.6 cm (2.2 in.)
• 過濾面積: 0.048 m²
• 入口接頭直徑: 3/4 in.
• 入口到出口寬度: 11.9 cm (4.7 in.)
• 出口接頭直徑: 3/4 in.
• 雜質: ≤0.25 EU/mL (LAL test, Aqueous extraction); <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• 重量法萃取物: ≤3 mg
• 基質: Millipore Express^® SPG
• 孔徑: 0.2 μm pore size
• 起泡點: ≥1210 mbar (17.5 psig), air with 70/30% IPA/water at 23 °C
• 接頭: 1/4 in. drain/vent hose barb (with double O-ring seal); inlet sanitary flange; outlet sanitary flange; (19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)
• 運輸包裝: ambient

说明

一般說明

Device Configuration: 取样皿滤膜

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
Gamma compatible to 45 kGy; 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable

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).

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.

HydroCorr: ≤0.16 mL/min @ 2.6 bar (38 psig)

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

TOC/Conductivity
After gamma irradiation and three autoclave cycles, the TOC was measured to be equal to or less than 3367 µg/device.

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

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

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

免責聲明

EMD Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.