MFGL04GF3
Durapore® 0.22 µm, Millipak® Final Fill灌装囊式过滤器
Millipak® Final Fill 40, non-sterile (non-sterilized), pore size 0.22 μm
别名:
Millipak® Final Fill 40
产品名称
Durapore® 0.22 µm, Millipak® Final Fill灌装囊式过滤器, Millipak® Final Fill 40, non-sterile (non-sterilized), pore size 0.22 μm
material
PVDF membrane
polysulfone device
polysulfone support
agency
certified by the ISO 9001:2015 (Quality Management Systems)
meets requirements for EP 2.6.14
meets requirements for JP 4.01
meets requirements for USP 85
sterility
irradiated
non-sterile (non-sterilized)
sterilization compatibility
gamma compatible
product line
Millipak® Final Fill 40
feature
hydrophilic
packaging
bag of 3 × double easy-open bag
parameter
1.0 L/min flow rate at 0.69 bar
10 psi max. differential pressure (0.7 bar) at 25 °C (Reverse)
25 psi max. differential pressure (1.7 bar) at 25 °C (Forward)
50 psi max. differential pressure (3.5 bar) at 25 °C (Forward)
60 psi max. differential pressure (4.1 bar) at 25 °C (Forward)
60 psi max. inlet pressure (4.1 bar) at 25 °C
80 psi max. differential pressure (5.5 bar) at 25 °C (Forward)
80 psi max. inlet pressure (5.5 bar) at 25 °C
technique(s)
sterile filtration: suitable
L
3.4 in.
W
3.0 in.
filtration area
200 cm2
impurities
<0.25 EU/mL bacterial endotoxins (LAL test)
matrix
Durapore®
pore size
0.22 μm pore size
bubble point
≥50 psi (3450 mbar), air with water at 23 °C
fitting
3/4 in. inlet connection
19 mm (3/4 in.) inlet/outlet connection (sanitary flange)
(19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)
Quality Level
Analysis Note
General description
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
Packaging
Preparation Note
Device integrity and retention was maintained after 3 autoclave cycles of 90 minutes at 126 <nbsp/>°C. Devices can withstand a dose ? 40<nbsp/> kGy gamma exposure.
Legal Information
法规信息
相关内容
This page summarizes key considerations related to regulatory expectations for biomanufacturing including chemicals and polymeric materials. For chemicals, topics include nitrosamines and elemental impurities, and for polymeric materials such as filters and single-use assemblies, the focus is qualification and extractable and leachable testing.
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