物料
polyester support
polyethersulfone
polypropylene (gamma-stable)
polypropylene housing
polypropylene vent cap (Gamma stable)
polysulfone
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
irradiated
sterile
产品线
Opticap® XL 600
特点
hydrophilic
制造商/商品名称
Millipore Express®
参数
≤3.7 mL/min air diffusion at 3.45 bar (50 psig) and 23 °C (in water)
1.0 bar max. differential pressure (15 psid) at 80 °C (Forward)
1.0 bar max. inlet pressure (15 psi) at 80 °C
100 psi max. differential pressure (6.9 bar) (intermittent)
2.1 bar max. differential pressure (30 psid) at 25 °C (Reverse; intermittent)
2.75 bar max. inlet pressure (40 psi) at 60 °C
25 °C max. inlet temp.
5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
5.5 bar max. inlet pressure (80 psi) at 25 °C
6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent)
6.9 bar max. inlet pressure (100 psi) at 25 °C (intermittent)
80 psi max. differential pressure (5.5 bar) (continuous)
80 psig max. inlet pressure
技术
sterile filtration: suitable
长度
16.5 cm (6.5 in.)
纯化柱标称长度
6.5 in. (16.5 cm)
直径
10.9 cm (4.3 in.)
过滤面积
600 cm2
入口接头直径
3/4 in.
入口至出口宽度
16.5 cm (6.5 in.)
出口接头直径
3/4 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
Millipore Express® SHR (w/Prefilter)
pore size
0.5/0.1 μm pore size
泡点
≥2586 mbar (37.5 psig), nitrogen with 70/30% IPA/water at 23 °C
配件
1/4 in. drain/vent hose barb (with double O-ring Seal)
inlet sanitary flange
outlet sanitary flange
(19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)
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 installation section of OPTICAP® XL Capsules and OPTICAP® XLT Capsules 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
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 of 3.0 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.
法律信息
免责声明
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