跳转至内容
Merck
CN

主要文件

查看所有文档

KVVLS2TTT1

Durapore® 0.1 µm, Opticap® XLT Capsule

Opticap® XLT 20, sterile, inlet connection diam. 1.5 in., cartridge nominal length 20 in. (50 cm)

别名:

Durapore® 0.1 µm，Opticap® XLT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

无菌 Opticap XLT 20 带有 Phil Dur - 20" 0.1 µm TC/TC 1 件装, Chemistry: Hydrophilic Polyvinylidene Fluoride (PVDF)Inlet: 1-1/2 in. Sanitary FlangeOutlet: 1-1/2 in. Sanitary FlangeT-lineMax Operating Pressure: 80 psi @ 25 °C

Quality Segment

400

material

PVDF , polyester support, polyethylene support, polypropylene (gamma-stable), polypropylene housing, polypropylene vent cap, silicone seal

reg. compliance

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

sterility

irradiated, sterile

product line

Opticap® XLT 20

feature

hydrophilic

manufacturer/tradename

Opticap®

parameter

1.0 bar max. inlet pressure (15 psi) at 80 °C, 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward), 2.8 bar max. inlet pressure (40 psi) at 60 °C, 25 °C max. inlet temp., 3.5 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 23 °C, 80 psig max. inlet pressure

technique(s)

sterile filtration: suitable

L

62.5 cm (24.6 in.)

cartridge nominal length

20 in. (50 cm)

diam.

10.7 cm (4.2 in.)

filtration area

1.45 m2

inlet connection diam.

1.5 in.

inlet to outlet W

15.2 cm (6.0 in.)

outlet connection diam.

1.5 in.

impurities

≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction), <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

gravimetric extractables

≤50 mg/capsule

matrix

Durapore®

pore size

0.1 μm

input

sample type liquid

bubble point

≥4830 mbar (70 psig), air with water at 23 °C

fitting

1/4 in. drain/vent hose barb (with double O-ring Seal), inlet sanitary flange, outlet sanitary flange, (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

General description

Device Configuration: 取样皿滤膜
T-line/Gauge Port: T-line

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method
3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
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).

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.
Gravimetric Extractables: after 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 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 Wetting Instructions for Filter Units with Durapore® Membrane 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
Durapore 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 无菌 Opticap XLT 20 带有 Phil Dur - 20" 0.1 µm TC/TC 1 件装

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