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Merck
CN

KVHLA2THH1

Millipore

Durapore® 0.45 µm，带预滤器，Opticap® XL囊式

Opticap® XLT 20, cartridge nominal length 20 in. (50 cm), filter diam. 4.2 in. (10.7 cm), pore size 0.45 μm

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UNSPSC代码:
23151806

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物料

mixed cellulose esters (MCE) prefilter
polypropylene device
polypropylene housing
polypropylene support
polypropylene vent cap

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 20

特点

hydrophilic

制造商/商品名称

Opticap®

参数

max. inlet temp. at 25 °C
≤15 mL/min air diffusion at 1.5 bar (22 psig) (in water)
1.05 bar max. differential pressure (15 psid) at 80 °C (Forward)
2.75 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

bioburden reduction: suitable

纯化柱标称长度

20 in. (50 cm)

设备尺寸

20 in.

过滤器直径

4.2 in. (10.7 cm)

过滤器过滤面积

1.2 m2

入口至出口宽度

24.6 in. (62.5 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

0.45 μm pore size

泡点

≥1930 mbar (28 psig), air with water at 23 °C

配件

1/4 in. drain/vent connection (with double O-ring Seal)
 (16 mm (5?8 in.) Hose Barb 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.
Effluent was negative after a water flush of 1 L per autoclaved sample
Gravimetric Extractables: ≤ 50 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

法规信息

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