Quality Segment
material
polyethersulfone membrane, polypropylene housing, polypropylene support, polypropylene vent cap, silicone seal
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
EMPROVE® Filter, Milligard®
feature
hydrophilic
manufacturer/tradename
Milligard®
parameter
1.38 bar max. differential pressure (20 psid) at 25 °C (Reverse), 5.52 bar max. differential pressure (80 psid) at 4-25 °C (Forward)
technique(s)
bioburden reduction: suitable
L
317.5 mm (12.5 in.)
W
2.7 in.
cartridge nominal length
10 in. (25 cm)
diam.
69 mm (2.71 in.)
filtration area
0.6 m2
impurities
<0.25 EU/mL bacterial endotoxins (LAL test, per device; aqueous extraction; meeting requirements of USP <85>, EP 2.6.14 and JP 4.01)
matrix
Milligard® PES
pore size
1.2/0.2 μm nominal pore size, 1.2/0.2 μm pore size
input
sample type liquid
cartridge code
Code 7
General description
Preparation Note
Autoclave wet 25x, 60 minute cycles at 128 °C. Or in-line steam (wet) 10 forward cycles, 30 minutes ≤ 135 °C at ≤ 4 psid and 5 reverse cycles, 30 min., ≤ 135 °C at <1.0 psid*.
*Devices were validated using steam at full differential pressure starting at 31 psid to a final differential pressure of 1 psid, resulting in a calculated average of 4 psid in forward and reverse directions.
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 wetting instructions of Filters with MILLIGARD® PES Membrane user guide
- Storage Statement: Please refer Filters with MILLIGARD® PES Membrane user guide
- Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.
Legal Information
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