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Merck
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CVGL75S01

Millipore

Durapore® 0.22 µm，小柱

pore size 0.22 μm, cartridge nominal length 5 in. (12.5 cm), Code 7 (2-226; O-rings w/locking-tabs)

别名:

Durapore Cartridge Filter 5 in. 0.22 μm Code 7

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About This Item

分類程式碼代碼:
23151806
eCl@ss:
32031690

材料

PVDF
polypropylene
polypropylene support
silicone seal

品質等級

400

法律遵循

meets EU framework regulation [1935/2004/EC] (all component materials; regarding materials and articles intended to contact food)
meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)

無菌

non-sterile

滅菌相容性

autoclavable compatible
steam-in-place compatible

產品線

Durapore®
EMPROVE® Filter

特點

hydrophilic

製造商／商標名

Durapore®

參數

≤6.6 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water)
0.35 bar max. differential pressure (5 psid) at 135 °C (Forward)
0.35 bar max. inlet pressure (5 psi) at 135 °C (Forward)
1.7 bar max. differential pressure (25 psid) at 80 °C (Forward)
1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward)
25 L/min flow rate at 1.4 bar (ΔP)
3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse)
3.5 bar max. inlet pressure (50 psi) at 25 °C (Reverse)
5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
5.5 bar max. inlet pressure (80 psi) at 25 °C (Forward)

技術

sterile filtration: suitable

長度

5 in.

寬度

2.7 in.

柱標稱長度

5 in. (12.5 cm)

直徑

6.9 cm (2.7 in.)

過濾面積

0.35 m2

雜質

≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

重量法萃取物

≤10 mg/cartridge

基質

Durapore®

孔徑

0.22 μm pore size

輸入

sample type liquid

起泡點

≥3450 mbar (50 psig), air with water at 23 °C

柱代碼

Code 7 (2-226; O-rings w/locking-tabs)

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相关类别

一般說明

设备配置：纯化柱

包裝

双易开袋

其他說明

这些产品在符合FDA药品生产质量管理规范的工厂生产。
使用说明

  • 生物截留：微生物
  • 作用机制：过滤（体积排阻）
  • 应用：生物处理
  • 预期用途：减少或去除微生物/生物负荷
  • 使用说明：请参阅《Durapore®薄膜用户指南》中的过滤器单元润湿说明
  • 储存条件：干燥储存
  • 处置声明：根据国家、省市和当地适用法规处置。

準備報告

本产品采用符合21 CFR 210.3(b)（6）中规定的“无纤维释放”过滤器标准的Durapore®膜制造。
灭菌方法
30个SIP循环，30 min @ 135 °C; 30个高压灭菌循环，60 min @ 126 °C

分析報告

用水冲洗 ≥500 mL 后，将满足 USP 可氧化物质测试要求
细菌保留
使用ASTM® F838方法，对样品进行最小保留的缺陷短波单孢菌挑战浓度为 1 × 10⁷ CFU/cm² 的定量保留。
重量提取物:在受控室温下在水中放置24小时后

法律資訊

ASTM is a registered trademark of American Society for Testing and Materials
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany

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