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KGEPS1THH1

Millipore

Millipore Express® SHF，Opticap® XLT囊式

sterile, Opticap® XLT 10, cartridge nominal length 10 in. (25 cm), filter diam. 10.7 cm (4.2 in.)

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UNSPSC代码:
23151806

物料

polyester support
polypropylene device (gamma stable)
polypropylene housing
polypropylene vent cap
polysulfone device
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® XLT 10

特点

hydrophilic

制造商/商品名称

Millipore Express®

参数

≤32.7 mL/min air diffusion at 2.8 bar (40 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 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

纯化柱标称长度

10 in. (25 cm)

device L

37.6 cm (14.8 in.)

device size

10 in.

过滤器直径

10.7 cm (4.2 in.)

filter filtration area

0.57 m2

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® SHF

孔径

0.2 μm pore size

泡点

≥4000 mbar (58 psig), air with water

配件

(16 mm (5?8 in.) Hose Barb Inlet and Outlet)

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一般描述

Sterile capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle.

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 11 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 ≥ 1.5 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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