跳转至内容
Merck
CN

主要文件

查看所有文档

KGEPA05HH1

Millipore Express® SHF 0.2µm, Opticap® XL 5 Capsule

Fittings 9/16 in. HB/HB, Autoclavable

别名:

Millipore Express® SHF, 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 XL 5 Millipore Express SHF 可高压蒸汽灭菌 0.2 µm 9/16 in.HB/HB, Chemistry: Hydrophilic Polyethersulfone (PES) Inlet: 9/16 in. Hose Barb Outlet: 9/16 in. Hose Barb Max Operating Pressure: 80 psi @ 25 °C

Quality Level

400

material

polyethersulfone , polypropylene , polypropylene housing, polypropylene support, polypropylene vent cap, polysulfone , silicone seal

reg. compliance

meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)

sterility

non-sterile

sterilization compatibility

autoclavable compatible

product line

Opticap® XL 5

feature

hydrophilic

manufacturer/tradename

Millipore Express®

parameter

≤16.4 mL/min air diffusion at 2.8 bar (40 psig) and 23 °C (in water), 1.0 bar max. differential pressure (15 psid) at 80 °C (Forward), 1.0 bar max. inlet pressure (15 psi) at 80 °C, 100 psi max. differential pressure (6.9 bar) (intermittent), 2.1 bar max. differential pressure (30 psid) at 25 °C (Reverse; intermittent), 2.75 bar max. inlet pressure (40 psi) at 60 °C, 25 °C max. inlet temp., 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward), 5.5 bar max. inlet pressure (80 psi) at 25 °C, 6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent), 6.9 bar max. inlet pressure (100 psi) at 25 °C (intermittent), 80 psi max. differential pressure (5.5 bar) (continuous), 80 psig max. inlet pressure

technique(s)

sterile filtration: suitable

L

21.6 cm (8.5 in.)

cartridge nominal length

5 in. (12.5 cm)

diam.

10.7 cm (4.2 in.)

filtration area

0.29 m2

inlet connection diam.

9/16 in.

inlet to outlet W

21.6 cm (8.5 in.)

outlet connection diam.

9/16 in.

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® SHF

pore size

0.2 μm pore size

bubble point

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

fitting

1/4 in. drain/vent hose barb (with double O-ring seal), inlet hose barb, outlet hose barb, (14 mm (9/16 in.) Hose Barb Inlet and Outlet)

General description

Device Configuration: 取样皿滤膜

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method
3 autoclave cycles of 60 min @ 126 °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 5.5 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 XL 5 Millipore Express SHF 可高压蒸汽灭菌 0.2 µm 9/16 in.HB/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
KGEPA05HH104053252263521