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安全信息

MFVL06ST3

Millipore

Durapore® 0.1 µm, Millipak® Final Fill Capsule

Millipak® Final Fill 60

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About This Item

UNSPSC代码:
23151806

物料

polysulfone device
polysulfone support

质量水平

400

Agency

meets EP 2.6.14
meets JP 4.01
meets USP 85

无菌性

sterile; irradiated

产品线

Millipak® Final Fill 60

特点

hydrophilic

制造商/商品名称

Millipak®

参数

0.51 L/min flow rate at 0.69 bar (Δ P)
0.7 bar max. differential pressure (10 psi) at 25 °C (Reverse)
3.5 bar max. inlet pressure (50 psi) at 25 °C
5.5 bar max. differential pressure (80 psi) at 25 °C (Forward)

技术

sterile filtration: suitable

filter filtration area

300 cm2

入口接头直径

1.5 in. , sanitary flange

出口接头直径

1.5 in.

杂质

<0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

基质

Durapore®

孔径

0.1 μm pore size

泡点

≥4830 mbar (70 psi), air with water

配件

(38 mm (1½ in.) Sanitary Flange Inlet and Outlet)

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一般描述

Device Configuration: Gamma Gold Capsule

包装

Double Easy-Open Bag

制备说明

This product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b)(6), validated based on large volume parenteral specifications as detailed in USP 788 Particulate Matter in Injections

分析说明

Bacterial Retention: Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC® 19146 per ASTM® F838 methodology.

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 general guidelines section of user guide shipped with this product
  • Storage Statement: Please refer user guide shipped with this product
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

These products are manufactured in a facility which is certified to ISO 9001:2015 Quality Management Systems.

法律信息

ASTM is a registered trademark of American Society for Testing and Materials
ATCC is a registered trademark of American Type Culture Collection
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
MILLIPAK is a registered trademark of Merck KGaA, Darmstadt, Germany

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