物料
polyethersulfone membrane
polypropylene housing
polypropylene support
polypropylene vent cap
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
autoclavable compatible
steam-in-place compatible
产品线
EMPROVE® Filter
Milligard®
特点
hydrophilic
制造商/商品名称
Milligard®
参数
1.38 bar max. differential pressure (20 psid) at 25 °C (Reverse)
5.52 bar max. differential pressure (80 psid) at 4-25 °C (Forward)
技术
bioburden reduction: suitable
长度
22.8 in.
宽度
2.7 in.
纯化柱标称长度
20 in. (50 cm)
直径
69 mm (2.71 in.)
过滤面积
1.20 m2
杂质
<0.25 EU/mL bacterial endotoxins (LAL test, per device; aqueous extraction; meeting requirements of USP <85>, EP 2.6.14 and JP 4.01)
基质
Milligard® PES
pore size
1.2/0.2 μm nominal pore size
1.2/0.2 μm pore size
输入
sample type liquid
柱代码
Code 7
相关类别
一般描述
特点和优势
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 of Filters with MILLIGARD® PES Membrane user guide
- Storage Statement: Please refer Filters with MILLIGARD® PES Membrane user guide
- Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.
制备说明
Autoclave wet 25x, 60 minute cycles at 128°C. In-line steam (wet): 10 forward cycles, 30 min.,
135 °C at ≤0.34 bar (5 psid) and 5 reverse cycles,
30 min., 135 °C at ≤0.07 bar (<1 psid)*.
*Devices were validated using steam at full differential pressure starting at 31 psid to a final differential pressure of 1 psid, resulting in a calculated average of 4 psid in forward and reverse directions.
法律信息
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