Merck
All Photos(1)

MFGB02GH3

Millipore

Millipak® Final Fill 20 Filter Unit

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

non-sterile

特点

hydrophilic

manufacturer/tradename

Millipak®

参数

0.35 bar max. differential pressure (5 psid) at 121 °C (Reverse)
0.51 L/min flow rate at 0.69 bar (ΔP)
10 psi max. differential pressure (0.7 bar) at 25 °C (Reverse)
20 L process volume
25 psi max. differential pressure (1.7 bar) at 80 °C (Forward)
3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse; intermittent)
5.5 bar max. inlet pressure (80 psi) at 25 °C
50 psi max. differential pressure (3.5 bar) at 25 °C (Forward)
60 psi max. differential pressure (4.1 bar) at 25 °C (Forward)

filter filtration area

100 cm2

杂质

<0.25 EU/mL USP bacterial endotoxins (LAL test, per device; aqueous extraction)
<0.25 EU/mL bacterial endotoxins (LAL test, per device; aqueous extraction)

基质

Durapore®

孔径

0.22 μm pore size

配件

1/4 in. (6 mm) inlet connection (stepped hose barb)
1/4 in. (6 mm) outlet connection (stepped hose barb)

Looking for similar products? Visit Product Comparison Guide

一般描述

Device Configuration: Capsule

包装

Double Easy-Open bag

制备说明

Sterilization Method: Device integrity and retention was maintained after 3 autoclave cycles of 90 minutes at 126  °C. Devices can withstand a dose ≤40  kGy gamma exposure.

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 Grow-Through: Quantitative retention of 1 x 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

Certificate of Analysis

Enter Lot Number to search for Certificate of Analysis (COA).

Certificate of Quality

Enter Lot Number to search for Certificate of Quality (COQ).

Our team of scientists has experience in all areas of research including Life Science, Material Science, Chemical Synthesis, Chromatography, Analytical and many others.

Contact Technical Service