产品名称
Durapore® 0.22 µm，Opticap® XL囊式, Opticap® XL, inlet connection diam. 1.5 in.
Quality Level
material
PVDF membrane
polypropylene housing
polypropylene support
polypropylene vent cap
silicone O-ring
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
product line
Opticap® XL
feature
hydrophilic
manufacturer/tradename
Durapore®
parameter
1.0 bar max. differential pressure (15 psid) at 80 °C (Forward)
1.0 bar max. inlet pressure (15 psi) at 80 °C
3.4 bar max. differential pressure (50 psid) at 25 °C (Reverse; intermittent)
5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
5.5 bar max. inlet pressure (80 psi) at 23 °C
technique(s)
sterile filtration: suitable
device L
5 in. (12.5 cm)
filtration area
0.35 m2
inlet connection diam.
1.5 in.
inlet to outlet W
21.6 cm (8.5 in.)
outlet connection diam.
1.5 in.
impurities
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
gravimetric extractables
≤15 mg/capsule
matrix
Durapore®
pore size
0.22 μm
input
sample type liquid
bubble point
≥3450 mbar (50 psig), air with water at 23 °C
fitting
38 mm (1 1/2 in.) inlet sanitary flange
38 mm (1 1/2 in.) outlet sanitary flange
正在寻找类似产品? 访问 产品对比指南
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 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.
Packaging
Preparation Note
3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable
Analysis Note
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
General description
Disclaimer
Legal Information
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.
我们的科学家团队拥有各种研究领域经验，包括生命科学、材料科学、化学合成、色谱、分析及许多其他领域.
联系客户支持