物料
polyethersulfone
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
irradiated
non-sterile
灭菌适用性
gamma compatible
产品线
Opticap® XL 150
特点
hydrophilic
制造商/商品名称
Millipore Express®
参数
≤1.4 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 23 °C
6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent)
6.9 bar max. inlet pressure (100 psi) at 23 °C (intermittent)
80 psi max. differential pressure (5.5 bar) (continuous)
80 psig max. inlet pressure
技术
sterile filtration: suitable
长度
9.7 cm (3.8 in.)
宽度
2.2 in.
纯化柱标称长度
3.8 in. (9.7 cm)
直径
5.6 cm (2.2 in.)
过滤面积
250 cm2
入口接头直径
3/4 in.
入口至出口宽度
9.7 cm (3.8 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
孔径
0.1 μm
泡点
≥4000 mbar (58 psig), air with water at 23 °C
配件
1/4 in. drain/vent hose barb (with double O-ring Seal)
(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
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 of 2.0 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.
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