Quality Level
cartridge code
Code 7
material
polyethersulfone membrane, polypropylene housing, polypropylene support, polysulfone (core), silicone O-ring
reg. compliance
meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
sterility
non-sterile
sterilization compatibility
autoclavable compatible
steam-in-place compatible
product line
Millipore Express®
feature
hydrophilic
parameter
1.7 bar max. differential pressure (25 psi) at 80 °C (Forward), 2.1 bar max. differential pressure (30 psi) at 25 °C (Reverse), 340 bar max. differential pressure (5 psi) at 135 °C (Forward), 6.9 bar max. differential pressure (100 psi) at 25 °C (Forward), 69 mbar max. differential pressure (1 psi) at 135 °C (Reverse)
technique(s)
sterile filtration: suitable
L
76.2 cm (30 in.)
diam.
10.7 cm (8.1 in.)
filtration area
1.62 m2 (17.4 ft2)
impurities
<0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
matrix
Millipore Express® SHF
pore size
0.2 μm pore size
bubble point
≥4000 mbar (58 psig), air with water at 23 °C
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General description
Application
Features and Benefits
- Sterilizing-grade membranes that are easy to wet and integrity test
- High flux PES membrane that provides superior processing efficiency
- Broad chemical compatibility across a wide pH range
- 100% integrity tested during the manufacturing process
Analysis Note
After sterilization and a controlled water flush of 30 L, samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645> at 25 °C.
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 107 CFU/cm² using ASTM® F838 methodology.
Other Notes
- Organism Retention: Microorganism
- Mode of Action: Filtration (size exclusion)
- Application: BioProcessing
- Intended Use: Reduction or removal of microorganism/bioburden
- Instructions for Use: Please refer to Millipore Express® Membrane user guide
- Storage Statement: Please refer to Millipore Express® Membrane user guide
- 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
Regulatory Information
Certificates of Analysis (COA)
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