跳转至内容
Merck
CN

主要文件

查看所有文档

KHGEG015FB3

Millipore Express® SHC 0.5/0.2µm, Opticap® XL 150 Capsule

Fittings 3/4 in. TC- 9/16 in. HB with Bell, Gamma Compatible

别名:

Millipore Express® SHC，Opticap® XL囊式

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

Opticap 可γ辐照 XL 150 Millipore Express SHC 0.5/0.2 µm 3/4 in.TC-9/16 in.带灌注钟罩的 HB, Chemistry: Hydrophilic Polyethersulfone (PES)Inlet: 3/4 in. Sanitary FlangeOutlet: 9/16 in. Hose Barb with BellMax Operating Pressure: 80 psi @ 25 °C

Quality Level

400

material

polyester support, polyethersulfone membrane, polypropylene housing, 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
gamma compatible
x-ray compatible

product line

Opticap® XL

feature

hydrophilic

manufacturer/tradename

Millipore Express®

parameter

1.0 bar max. differential pressure (15 psid) at 80 °C, 1.0 bar max. inlet pressure (15 psi) at 80 °C, 100 psi max. inlet pressure (6.9 bar) at 23 °C (intermittent), 2.1 bar max. differential pressure (30 psi) at 25 °C (Reverse; intermittent), 2.8 bar max. inlet pressure (40 psi) at 60 °C, 5.5 bar max. inlet pressure (80 psid) at 25 °C, 6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent), 80 psi max. differential pressure (5.5 bar) at 25 °C

device L

11.4 cm (4.5 in.)

filter diam.

5.6 cm (2.2 in.)

filtration area

0.014 m2 (0.155 ft2)

impurities

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

matrix

Millipore Express® SHC

pore size

0.5/0.2 μm pore size

bubble point

≥4000 mbar (58 psig), air with water at 23 °C

fitting

19 mm (3/4 in.) inlet sanitary flange, 14 mm (9/16 in.) outlet hose barb (with filling bell)

General description

Device Configuration: 取样皿滤膜

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method
Gamma compatible to 45 kGy; 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
This product was manufactured with a Millipore Express® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Analysis Note

Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
TOC/Conductivity
After sterilization and a controlled water flush of 1.0 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L

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 installation section of OPTICAP® XL Capsules and OPTICAP® XLT Capsules user guide
  • Storage Statement: Store in dry location
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

Legal Information

ASTM is a registered trademark of American Society for Testing and Materials
MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany
OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany

Disclaimer

EMD Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.

Still not finding the right product?

Explore all of our products under Opticap 可γ辐照 XL 150 Millipore Express SHC 0.5/0.2 µm 3/4 in.TC-9/16 in.带灌注钟罩的 HB

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
KHGEG015FB304053252553578