跳转至内容
Merck
CN

MFHL06GT3

Millipak® Final Fill 60 Durapore®

Inlet: 1.5 in. Sanitary Flange Outlet: 1.5 in. Sanitary Flange Vent: 1/8 in. Hose Barb

别名:

Durapore® 0.45 µm, Millipak® Final Fill Capsule

登录 查看组织和合同定价。

选择尺寸

变更视图

关于此项目

UNSPSC Code:
23151806
技术服务
需要帮助?我们经验丰富的科学家团队随时乐意为您服务。
让我们为您提供帮助


产品名称

Durapore® 0.45 µm, Millipak® Final Fill灌装囊式过滤器, Inlet: 1.5 in. Sanitary Flange Outlet: 1.5 in. Sanitary Flange Vent: 1/8 in. Hose Barb

Quality Level

material

PVDF membrane, polysulfone housing, polysulfone support, 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

gamma compatible
x-ray compatible

product line

Millipak® Final Fill

feature

hydrophilic

manufacturer/tradename

Durapore®

parameter

0.7 bar max. differential pressure (10 psid) at 25 °C (Reverse), 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward), 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)

technique(s)

bioburden reduction: suitable

W

3.0 in.

filter diam.

7.6 cm (3.0 in.)

filter filtration area

300 cm2

impurities

<0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

matrix

Durapore®

pore size

0.45 μm pore size

bubble point

≥26 psi (1790 mbar), air with water at 23 °C

fitting

38 mm (1 1/2 in.) inlet sanitary flange, 38 mm (1 1/2 in.) outlet sanitary flange

General description

Device Configuration: Capsule

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method: Device integrity and retention was maintained after 3 autoclave cycles of 90 minutes at 126  °C. Devices can withstand a dose ≤40  kGy gamma exposure.

This product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b)(6), validated based on large volume parenteral specifications as detailed in USP 788 Particulate Matter in Injections

Other Notes

Directions for Use
  • Organism Retention: Microorganism
  • Mode of Action: Filtration (size exclusion)
  • Application: BioProcessing
  • Intended Use: Reduction or removal of microorganism/bioburden
  • Instructions for Use: Please refer general guidelines section of user guide shipped with this product
  • Storage Statement: Please refer user guide shipped with this product
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

These products are manufactured in a facility which is certified to ISO 9001:2015 Quality Management Systems.

Legal Information

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


Still not finding the right product?


法规信息

新产品

此项目有



使用 Emprove® 计划保持符合 GMP 要求

使用Emprove® Dossiers可加快资格认证、保持合规性并节省时间。

下载 Dossiers

注意:您将进入 EmproveSuite.com。您的用户名和密码与 SigmaAldrich.com 是分开的,可能不同

免费注册,几分钟内即可访问 Emprove® Dossiers 升级您的订阅计划,解锁 Emprove® Suite 中的高级定制内容。

没有找到您要找的内容?访问 Emprove® 计划帮助页面

已有该产品?

在文件库中查找您最近购买产品的文档。

访问文档库





全球贸易项目编号

货号GTIN
MFHL06GT304054839379895