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Merck
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KHGEG3TTT1H

Millipore Express® SHC High Area 0.5/0.2µm, Opticap® XLT 30 Capsule

Fittings 1-1/2 in. TC, Gamma Compatible

别名:

Millipore Express® SHC 大面积,Opticap® XLT 囊式

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UNSPSC Code:
23151806
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产品名称

可γ辐照高过滤面积 Opticap XLT 30 Millipore Express SHC 0.5  µm/0.2 µm 1-1/2 in.TC, Chemistry: Hydrophilic Polyethersulfone (PES)Inlet: 1-1/2 in. Sanitary FlangeOutlet: 1-1/2 in. Sanitary FlangeT-lineMax Operating Pressure: 80 psi @ 25 °C, Opticap® XLT 30, cartridge nominal length 30 in. (75 cm)

material

polyester support, polyethersulfone , polypropylene , polypropylene housing, polypropylene vent cap, polysulfone , silicone seal

reg. compliance

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

Quality Level

sterility

non-sterile

sterilization compatibility

gamma compatible

product line

Opticap® XLT 30

feature

hydrophilic

manufacturer/tradename

Millipore Express®

parameter

≤169.2 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water), 1.0 bar max. differential pressure (15 psi) at 80 °C (Forward), 2.1 bar max. differential pressure (30 psi) at 25 °C (Reverse; intermittent), 25 °C max. inlet temp., 5.5 bar max. differential pressure (80 psi) at 25 °C (Forward), 6.9 bar max. differential pressure (100 psi) at 25 °C (Forward; intermittent), 80 psig max. inlet pressure

technique(s)

sterile filtration: suitable

L

87.1 cm (34.3 in.)

W

7.8 in.

cartridge nominal length

30 in. (75 cm)

diam.

10.7 in. (4.2 cm)

filtration area

3.0 m2

inlet to outlet W

15.2 cm (6.0 in.)

outlet connection diam.

1.5 in.

impurities

≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)

matrix

Millipore Express® SHC High Area

pore size

0.5/0.2 μm pore size

bubble point

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

fitting

1/4 in. drain/vent hose barb (with double O-ring seal), inlet sanitary flange, outlet sanitary flange, (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

application(s)

sample preparation

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General description

T 线/仪表端口:T线

Packaging

双层易开袋

Preparation Note

本产品采用符合21 CFR 210.3(b)(6)中规定的“无纤维释放”过滤器标准的Millipore Express®膜制造。
灭菌方法
耐受45kGy伽马射线辐照剂量;123°C×60 min高压锅蒸汽灭菌,3次;不可在线蒸汽灭菌

Analysis Note

TOC/电导率
灭菌和63 L受控水冲洗后,按USP <64>检测,样品TOC小于500 ppb;按USP <64> (25 °C)检测,电导率小于1.3 µS/cm。
用水冲洗 ≥6 L 后,将满足 USP 可氧化物质测试要求
细菌截留
按ASTM® F838方法进行细菌挑战,样品可截留1 x 10⁷ CFU/cm²以上浓度的缺陷短波单孢菌

Other Notes

这些产品在符合FDA药品生产质量管理规范的工厂生产。

Legal Information

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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