物料
PVDF
polyester support
polyethylene support
polypropylene
polypropylene housing
polypropylene vent cap
silicone seal
质量水平
管理合规性
meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
无菌性
non-sterile
灭菌适用性
gamma compatible
产品线
Opticap® XLT 10
特点
gamma compatible
hydrophilic
制造商/商品名称
Opticap®
参数
≤15.0 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water)
1.0 bar max. inlet pressure (15 psi) at 80 °C
1.05 bar max. differential pressure (15 psid) at 80 °C (Forward)
2.75 bar max. inlet pressure (40 psi) at 60 °C
25 °C max. inlet temp.
3.5 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
80 psig max. inlet pressure
技术
sterile filtration: suitable
长度
37.6 cm (14.8 in.)
宽度
6.0 in.
纯化柱标称长度
10 in. (25 cm)
直径
10.7 cm (4.2 in.)
过滤面积
0.6 m2
入口接头直径
1.5 in.
入口至出口宽度
15.2 cm (6.0 in.)
出口接头直径
1.5 in.
杂质
≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
<0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
基质
Multilayer Durapore®
pore size
0.45/0.22 μm pore size
输入
sample type liquid
泡点
≥3450 mbar (50 psig), air with water at 23 °C
配件
1/4 in. drain/vent hose barb (with double O-ring Seal)
inlet sanitary flange
outlet sanitary flange
(38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)
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一般描述
包装
其他说明
- 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.
制备说明
Gamma compatible to 45 kGy; 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
分析说明
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
After sterilization and a controlled water flush, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 ºC.
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