KVGLA04HH3

Durapore^® 0.22 µm，Opticap^® XL囊式

Opticap^® XL, inlet connection diam. 9/16 in.

• 别名: Opticap XL4 Durapore 0.22 μm 9/16 in. HB/HB
• UNSPSC Code: 23151806

属性

• 产品名称: Durapore^® 0.22 µm，Opticap^® XL囊式, Opticap^® XL, inlet connection diam. 9/16 in.
• material: silicone seal; PVDF membrane; polypropylene housing; polypropylene support; polypropylene vent cap; silicone O-ring
• reg. compliance: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• sterility: non-sterile
• sterilization compatibility: autoclavable compatible
• feature: hydrophilic
• Quality Level: 400
• product line: Opticap^® XL
• manufacturer/tradename: Durapore^®
• parameter: 1 bar max. differential pressure (15 psid) at 80 °C (Forward); 1 bar max. inlet pressure (15 psi) at 80 °C; 3.4 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 25 °C
• technique(s): sterile filtration: suitable
• L: 4 in. (10 cm)
• filtration area: 0.19 m²
• inlet connection diam.: 9/16 in.
• inlet to outlet W: 19.3 cm (7.6 in.)
• outlet connection diam.: 9/16 in.
• impurities: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• gravimetric extractables: ≤10 mg/capsule
• matrix: Durapore^®
• pore size: 0.22 μm
• input: sample type liquid
• bubble point: ≥3450 mbar (50 psig), air with water at 23 °C
• fitting: 14 mm (9/16 in.) inlet hose barb; 14 mm (9/16 in.) outlet hose barb

说明

Analysis Note

可提取物质量：在受控室温下在水中放置24小时后称量

用水冲洗 ≥500 mL 后，将满足 USP 可氧化物质测试要求

细菌截留
按ASTM^® F838方法进行细菌挑战，样品可截留1 x 10⁷ CFU/cm²以上浓度的缺陷短波单孢菌。

Disclaimer

EMD Millipore Corporation保证，本品符合欧盟承压设备指令(European Pressure Equipment Directive, 97/23/EC of 29 May 1997)要求。本品依照欧盟承压设备指令Article 3 § 3条款要求分类。根据安全工程规范(sound engineering practice)设计和生产，确保安全使用。根据承压设备指令Article 3 § 3条款要求，本品不带CE标志。

General description

设备配置：胶囊

Other Notes

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：参见《Durapore^® 滤膜过滤器润湿说明》用户手册
• 存储声明：干燥储存
• 处置声明：根据国家、省市和当地适用法规处置。

替代品：KVGL04HB3

这些产品在符合FDA药品生产质量管理规范的工厂生产。

Packaging

双层易开袋

Preparation Note

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
3次高压灭菌循环，每次60 min，126°C；不可在线蒸汽灭菌

Legal Information

ASTM is a registered trademark of American Society for Testing and Materials

Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany

OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany