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Merck
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KHVES10HH1

Millipore

Opticap 无菌 XL 10 Millipore Express SHR 带预滤器 0.5/0.1 µm 9/16 in. HB/HB

Opticap® XL 10, sterile, inlet connection diam. 9/16 in., pore size 0.5/0.1 μm, cartridge nominal length 10 in. (25 cm)

别名:

Millipore Express® SHRP，Opticap® XL囊式

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About This Item

UNSPSC代码:
23151806

物料

polyester support
polyethersulfone
polypropylene (gamma-stable)
polypropylene housing
polypropylene vent cap (Gamma stable)
polysulfone
silicone seal

质量水平

400

管理合规性

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

无菌性

irradiated
sterile

产品线

Opticap® XL 10

特点

hydrophilic

制造商/商品名称

Millipore Express®

参数

≤30.4 mL/min air diffusion at 3.45 bar (50 psig) and 23 °C (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 25 °C
6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent)
6.9 bar max. inlet pressure (100 psi) at 25 °C (intermittent)
80 psi max. differential pressure (5.5 bar) (continuous)
80 psig max. inlet pressure

技术

sterile filtration: suitable

长度

33.5 cm (13.2 in.)

纯化柱标称长度

10 in. (25 cm)

直径

14.5 cm (5.7 in.)

过滤面积

0.54 m2

入口接头直径

9/16 in.

入口至出口宽度

33.5 cm (13.2 in.)

出口接头直径

9/16 in.

杂质

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

基质

Millipore Express® SHR (w/Prefilter)

pore size

0.5/0.1 μm pore size

泡点

≥2586 mbar (37.5 psig), nitrogen with 70/30% IPA/water at 23 °C

配件

1/4 in. drain/vent hose barb (with double O-ring Seal)
 inlet hose barb
 outlet hose barb
 (14 mm (9/16 in.) Hose Barb Inlet and Outlet)

相关类别

一般描述

Device Configuration: 取样皿滤膜

包装

Double Easy-Open bag

其他说明

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 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.

制备说明

Sterilization Method
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 20 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L

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

免责声明

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.

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