跳转至内容
Merck
CN

主要文件

查看所有文档

KVGLA1THH1

Durapore® 0.22 µm, Opticap® XLT Capsule

Opticap® XLT

别名:

Durapore® 0.22 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

Opticap XLT10 Durapore 0.22 µm 5/8 in.HB/HB, Chemistry: Hydrophilic Polyvinylidene Fluoride (PVDF)Inlet: 5/8 in. Hose BarbOutlet: 5/8 in. Hose BarbT-line Max Operating Pressure: 80 psi @ 25 °C

Quality Level

400

material

silicone seal, PVDF membrane, polypropylene housing, polypropylene support, polypropylene vent cap, 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

product line

Opticap® XLT

feature

hydrophilic

manufacturer/tradename

Durapore®

parameter

1.0 bar max. differential pressure (15 psid) at 80 °C (Forward), 1.0 bar max. inlet pressure (15 psi) at 80 °C, 3.4 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

technique(s)

sterile filtration: suitable

device L

10 in. (25 cm)

filtration area

0.69 m2

impurities

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

gravimetric extractables

≤25 mg/capsule

matrix

Durapore®

pore size

0.22 μm

input

sample type liquid

bubble point

≥3450 mbar (50 psig), air with water at 23 °C

fitting

16 mm (5/8 in.) inlet hose barb, 16 mm (5/8 in.) outlet hose barb

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 @ 126 °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 ≥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 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 Opticap XLT10 Durapore 0.22 µm 5/8 in.HB/HB

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
KVGLA1THH104053252570940