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KVEPS015FB3

Millipore

Millipore Express® SHR 0.1µm, Opticap® XL 150 Capsule

Fittings 3/4 in. TC- 9/16 in. HB with Bell, Sterile

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About This Item

UNSPSC代码:
23151806

产品名称

Millipore Express®SHR, Opticap® XL 囊式, sterile, Opticap® XL 150, cartridge nominal length 3.8 in. (9.7 cm), filter diam. 5.6 cm (2.2 in.)

物料

polyethylene support
polypropylene device
polypropylene housing
polypropylene vent cap
silicone seal

质量水平

400

管理合规性

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

无菌性

irradiated
sterile

产品线

Opticap® XL 150

特点

hydrophilic

制造商/商品名称

Millipore Express®

参数

≤1.4 mL/min air diffusion at 3.45 bar (50 psig) (in water)
1.0 bar max. differential pressure (15 psid) at 80 °C (Forward)
1.0 bar max. inlet pressure (15 psi) at 80 °C
100 psi max. differential pressure (6.9 bar) (intermittent)
2.1 bar max. differential pressure (30 psid) at 25 °C (Reverse; intermittent)
2.75 bar max. inlet pressure (40 psi) at 60 °C
25 °C max. inlet temp.
5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
5.5 bar max. inlet pressure (80 psi) at 23 °C
6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent)
6.9 bar max. inlet pressure (100 psi) at 23 °C (intermittent)
80 psi max. differential pressure (5.5 bar) (continuous)
80 psig max. inlet pressure

技术

sterile filtration: suitable

纯化柱标称长度

3.8 in. (9.7 cm)

设备长度

9.7 cm (3.8 in.)

过滤器直径

5.6 cm (2.2 in.)

过滤器过滤面积

250 cm2

杂质

≤0.25 EU/mL bacterial endotoxins (LAL test, aqueous extraction)
<0.25 EU/mL USP bacterial endotoxins (sample aqueous extraction)

基质

Millipore Express® SHR

孔径

0.1 μm pore size

泡点

≥4000 mbar (58 psig), air with water

配件

(19 mm (¾ in.) Sanitary Flange Inlet and 14 mm (9/16 in.) Hose Barb Outlet with filling bell)

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相关类别

一般描述

Device Configuration: Capsule

包装

Double Easy-Open bag

制备说明

Sterilization Method:
3 autoclave cycles of 60 min at 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.
TOC/Conductivity: After sterilization and a controlled water flush of 2.0 L, samples exhibited &#x3C 500 ppb TOC per USP &#x3C 643 &#x3C and &#x3C 1.3 μS/cm per USP &#x3C 645 &#x3C at 25 °C.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 1 L

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 installation section of OPTICAP® XL Capsules and OPTICAP® XLT Capsules user guide
  • Storage Statement: Store in dry location
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

法律信息

ASTM is a registered trademark of American Society for Testing and Materials
MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany
OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany

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