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KGEPS3THH1

Millipore

Opticap XLT 30 Millipore Express SHF 无菌 0.2 µm 5/8 in.HB

Opticap® XLT 30, sterile, inlet connection diam. 5/8 in., cartridge nominal length 30 in. (75 cm)

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别名:
Millipore Express® SHF,Opticap® XLT囊式

物料

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

质量水平

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

≤98.2 mL/min air diffusion at 2.8 bar (40 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

87.1 cm (34.3 in.)

纯化柱标称长度

30 in. (75 cm)

直径

10.7 cm (4.2 in.)

过滤面积

1.71 m2

入口接头直径

5/8 in.

入口至出口宽度

19.8 cm (7.8 in.)

出口接头直径

5/8 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® SHF

孔径

0.2 μm

泡点

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

配件

1/4 in. drain/vent hose barb (with double O-ring seal)
inlet hose barb
outlet hose barb
(16 mm (5?8 in.) Hose Barb Inlet and Outlet)

一般描述

Device Configuration: 取样皿滤膜
T-line/Gauge Port: T-line
Sterile capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle.

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 33 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 ≥4.5 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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