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Merck

KVVLS3TTT1

Millipore

无菌 Opticap XLT 30 带有 Phil Dur - 30" 0.1 µm TC/TC 1 件装

Opticap® XLT 30, sterile, inlet connection diam. 1.5 in., cartridge nominal length 30 in. (75 cm)

别名:

Durapore® 0.1 µm,Opticap® XLT囊式

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About This Item

分類程式碼代碼:
23151806

材料

PVDF
polyester support
polyethylene support
polypropylene (gamma-stable)
polypropylene housing
polypropylene vent cap
silicone seal

品質等級

法律遵循

meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)

無菌

irradiated
sterile

產品線

Opticap® XLT 30

特點

hydrophilic

製造商/商標名

Opticap®

參數

1.0 bar max. inlet pressure (15 psi) at 80 °C
1.7 bar max. differential pressure (25 psid) at 80 °C (Forward)
2.8 bar max. inlet pressure (40 psi) at 60 °C
25 °C max. inlet temp.
3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse; intermittent)
5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
5.5 bar max. inlet pressure (80 psi) at 23 °C
80 psig max. inlet pressure

技術

sterile filtration: suitable

長度

87.1 cm (34.3 in.)

柱標稱長度

30 in. (75 cm)

直徑

10.7 cm (4.2 in.)

過濾面積

2.17 m2

入口接頭直徑

1.5 in.

入口到出口寬度

15.2 cm (6.0 in.)

出口接頭直徑

1.5 in.

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

≤75 mg/capsule

基質

Durapore®

孔徑

0.1 μm

輸入

sample type liquid

起泡點

≥4830 mbar (70 psig), air with water at 23 °C

接頭

1/4 in. drain/vent hose barb (with double O-ring Seal)
inlet sanitary flange
outlet sanitary flange
(38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

一般說明

Device Configuration: 取样皿滤膜
T-line/Gauge Port: T-line

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
3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
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 water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥3 L

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

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