跳转至内容
Merck
CN

主要文件

查看所有文档

MFGB02SH3

Millipak® Final Fill 20 Durapore®

Inlet: 1/4 in. Hose Barb Outlet: 1/4 in. Hose Barb Vent: 1/8 in. Hose Barb

别名:

Hydrophobic Durapore® 0.22 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

Millipak® Final Fill 20 Durapore®, Inlet: 1/4 in. Hose Barb Outlet: 1/4 in. Hose Barb Vent: 1/8 in. Hose Barb

Quality Level

400

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

sterile

product line

Millipak® Final Fill

feature

hydrophobic

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), 4.1 bar max. differential pressure (60 psid) at 25 °C (Forward)

technique(s)

sterile filtration: suitable

filter diam.

7.6 cm (3.0 in.)

filter filtration area

100 cm2

impurities

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

matrix

Durapore®

pore size

0.22 μm pore size

bubble point

≥29 psi (2000 mbar), air with water at 23 °C

fitting

6 mm (1/4 in.) inlet hose barb, 6 mm (1/4 in.) outlet hose barb

General description

Device Configuration: Gamma Gold 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

Analysis Note

Bacterial Grow-Through: Quantitative retention of 1 x 107 CFU/cm2 Brevundimonas diminuta ATCC® 19146 per ASTM® F838 methodology.

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

ASTM is a registered trademark of American Society for Testing and Materials
ATCC is a registered trademark of American Type Culture Collection
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?

Explore all of our products under

法规信息

新产品

此项目有

分析证书(COA)

输入产品批号来搜索 分析证书(COA) 。批号可以在产品标签上"批“ （Lot或Batch）字后找到。

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
MFGB02SH304054839378607