material
PVDF
Quality Level
sterility
sterile
product line
EMPROVE® Filter
feature
hydrophilic
manufacturer/tradename
Millipak®
filtration area
500 cm2
inlet connection diam.
1/4 in.
outlet connection diam.
1/4 in.
impurities
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
gravimetric extractables
≤2.5 mg/device
matrix
Durapore®
pore size
0.22 μm pore size
fitting
NPT inlet connection, NPT outlet connection
General description
Device Configuration: 取样皿滤膜
Number of stacked discs: 100 discs
Preparation Note
Sterilization Method
3 autoclave cycles of 90 min @ 123°C; not in-line steam sterilizable
3 autoclave cycles of 90 min @ 123°C; not in-line steam sterilizable
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).
Analysis Note
Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
Gravimetric Extractables: after 24 hours in water at controlled room temperature
Other Notes
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 for Filter Units with Durapore® Membrane user guide
- Storage Statement: Store in dry location
- Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Legal Information
ASTM is a registered trademark of American Society for Testing and Materials
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
MILLIPAK is a registered trademark of Merck KGaA, Darmstadt, Germany
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全球贸易项目编号
| 货号 | GTIN |
|---|---|
| MPGL10CB3 | 04053252608650 |
| MPGL10CB1 | 04053252253584 |