产品名称
Durapore® 0.22 µm, Millipak® Final Fill灌装囊式过滤器, Millipak® Final Fill
material
PVDF membrane, polysulfone housing, silicone O-ring
sterility
non-sterile
feature
hydrophilic
reg. compliance
meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
sterilization compatibility
gamma compatible
x-ray compatible
product line
Millipak® Final Fill
manufacturer/tradename
Durapore®
parameter
0.7 bar max. differential pressure (10 psid) at 25 °C (Reverse), 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward), 4.1 bar max. differential pressure (60 psid) at 25 °C (Forward)
technique(s)
sterile filtration: suitable
filter diam.
7.6 cm (3.0 in.)
filtration area
100 cm2
impurities
<0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
matrix
Durapore®
pore size
0.22 μm pore size
bubble point
≥50 psi (3450 mbar), air with water at 23 °C
fitting
6 mm (1/4 in.) inlet hose barb, 6 mm (1/4 in.) outlet hose barb
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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 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
Legal Information
法规信息
相关内容
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Learn more about mAb final filtration, the last steps in mAb processing, which assure drug sterility for patients.
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