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KHGES3FTT1

Millipore

无菌 Opticap XLT 30 Millipore Express SHC 0.5/0.2 µm TC/TC 1 件装 w/3/4" TC 顶部

Opticap® XLT 30, sterile, inlet connection diam. 1.5 in., pore size 0.5/0.2 μm, cartridge nominal length 30 in. (75 cm)

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别名:
Millipore Express® SHC，Opticap® XLT囊式
UNSPSC代码:
23151806

物料

polyester support
polyethersulfone
polypropylene
polypropylene housing
polypropylene vent cap
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® XLT 30

特点

hydrophilic

制造商/商品名称

Millipore Express®

参数

1.0 bar max. inlet pressure (15 psi) at 80 °C
1000 bar max. differential pressure (15 psi) at 80 °C (Forward)
2.75 bar max. inlet pressure (40 psi) at 60 °C
2100 bar max. differential pressure (30 psi) at 25 °C (Reverse; intermittent)
25 °C max. inlet temp.
5.5 bar max. inlet pressure (80 psi) at 25 °C
5500 mbar max. differential pressure (80 psi) at 25 °C (Forward)
6.9 bar max. inlet pressure (100 psi) at 25 °C (intermittent)
6900 mbar max. differential pressure (100 psi) at 25 °C (Forward; intermittent)
80 psig max. inlet pressure

技术

sterile filtration: suitable

长度

87.2 cm (34.3 in.)

纯化柱标称长度

30 in. (75 cm)

直径

19.8 cm (7.8 in.)

过滤面积

1.63 m2

入口接头直径

1.5 in.

出口接头直径

1.5 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® SHC

pore size

0.5/0.2 μm pore size

泡点

≥4000 mbar (58 psig), air with water at 23 °C

配件

3/4 in. gauge port
 inlet sanitary flange
 outlet sanitary flange
1/4 in. vent hose barb (with double O-ring Seal)
 (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

一般描述

Device Configuration: 取样皿滤膜
T-line/Gauge Port: T-line with 3/4 in. Gauge Port

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 @ 126 °C; capable of 45 kilogray (4.5 Megarad) gamma exposure; 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 63 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 ≥6 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

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