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Merck
CN

KVVLA3STT1

Millipore

Durapore® 0.1 µm，Opticap® XLT囊式

Opticap® XLT 30, cartridge nominal length 30 in. (15 cm), filter diam. 5.7 in. (14.5 cm), pore size 0.1 μm

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About This Item

UNSPSC代码:
23151806

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物料

polypropylene device
polypropylene housing
polypropylene support
polypropylene vent cap

质量水平

400

管理合规性

meets FDA 21 CFR 177-182 (all component materials)

无菌性

non-sterile

灭菌适用性

autoclavable compatible

产品线

Opticap® XLT 30

特点

hydrophilic

制造商/商品名称

Opticap®

参数

max. inlet temp. at 25 °C
≤60 mL/min air diffusion at 3.9 bar (56 psig) (in water)
1.7 bar max. differential pressure (25 psid) at 80 °C (Forward)
2.8 bar max. inlet pressure (40 psi) at 60 °C
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

技术

sterile filtration: suitable

长度

34.3 in.

宽度

6.0 in.

纯化柱标称长度

30 in. (15 cm)

设备尺寸

30 in.

过滤器直径

5.7 in. (14.5 cm)

过滤器过滤面积

2.1 m2

入口至出口宽度

34.3 in. (87.1 cm)

杂质

≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction)
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

基质

Durapore®

孔径

0.1 μm pore size

泡点

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

配件

1/4 in. drain/vent connection (with double O-ring Seal)
 (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

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一般描述

Device Configuration: Cartridge
Cartridge Type: Liquid

特点和优势

T-line/Gauge Port: T-line

制备说明

Sterilization Method: Capsule integrity was maintained after 3 autoclave cyclces of 60 minutes at 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).

分析说明

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: ≤ 75 mg per capsule after 24 hours in water at controlled room temperature.

其他说明

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

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

法律信息

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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