material
PVDF
reg. compliance
meets EU framework regulation [1935/2004/EC] (all component materials; regarding materials and articles intended to contact food), meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
sterility
sterile; γ-irradiated
feature
hydrophilic
manufacturer/tradename
Vitipore® II
cartridge nominal length
40 in. (100 cm)
gravimetric extractables
≤92 mg/cartridge
matrix
Vitipore® II
pore size
0.45 μm nominal pore size, 0.45 μm pore size
input
sample type beverage(s)
sample type wine
sample type beer
sample type bottled water
sample type liquid
sample type food(s)
cartridge code
Code 7 (2-226; O-rings w/locking-tabs)
General description
Device Configuration: Cartridge
Preparation Note
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
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
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
VITIPORE is a registered trademark of Merck KGaA, Darmstadt, Germany