Merck
CN

CMP271TS1

Millipore

Milligard PES 10" 1.2/0.2 标称 um 滤芯

pore size 1.2/0.2 μm, cartridge nominal length 10 in. (25 cm)

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别名:
Milligard® PES 1.2/0.2 µm 标称,小柱
eCl@ss:
32031690

物料

polyethersulfone membrane
polypropylene housing
polypropylene support
polypropylene vent cap
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

non-sterile

灭菌适用性

autoclavable compatible
steam-in-place compatible

产品线

EMPROVE® Filter
Milligard®

特点

hydrophilic

制造商/商品名称

Milligard®

参数

1.38 bar max. differential pressure (20 psid) at 25 °C (Reverse)
5.52 bar max. differential pressure (80 psid) at 4-25 °C (Forward)

技术

bioburden reduction: suitable

长度

317.5 mm (12.5 in.)

宽度

2.7 in.

纯化柱标称长度

10 in. (25 cm)

直径

69 mm (2.71 in.)

过滤面积

0.6 m2

杂质

<0.25 EU/mL bacterial endotoxins (LAL test, per device; aqueous extraction; meeting requirements of USP <85>, EP 2.6.14 and JP 4.01)

基质

Milligard® PES

pore size

1.2/0.2 μm nominal pore size
1.2/0.2 μm pore size

输入

sample type liquid

柱代码

Code 7

一般描述

Device Configuration: Cartridge

其他说明

The product is manufactured in a facility which adheres to Good Manufacturing Practices. The manufacturing facility’s Quality Management System is approved by an accredited registering body to the appropriate ISO 9001 Quality Standard.
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 wetting instructions of Filters with MILLIGARD® PES Membrane user guide
  • Storage Statement: Please refer Filters with MILLIGARD® PES Membrane user guide
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

制备说明

Sterilization Method
Autoclave wet 25x, 60 minute cycles at 128 °C. Or in-line steam (wet) 10 forward cycles, 30 minutes ≤ 135 °C at ≤ 4 psid and 5 reverse cycles, 30 min., ≤ 135 °C at <1.0 psid*.

*Devices were validated using steam at full differential pressure starting at 31 psid to a final differential pressure of 1 psid, resulting in a calculated average of 4 psid in forward and reverse directions.
This product was manufactured with materials that meet the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

法律信息

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
MILLIGARD is a registered trademark of Merck KGaA, Darmstadt, Germany

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