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KTGRA10FF1

Millipore

Aervent® 0.2 µm，Opticap® XL囊式

Opticap® XL 10, pore size 0.2 μm, hydrophobic, sterilization compatible with autoclavable, non-sterile, 19 mm (3/4 in.) inlet/outlet sanitary flange

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别名:
Aervent KTGR Opticap XL10 Capsule
UNSPSC代码:
23151806
eCl@ss:
32031690

物料

PTFE
polypropylene
polypropylene housing
polypropylene support
polypropylene vent cap
silicone seal

质量水平

400

无菌性

non-sterile

灭菌适用性

autoclavable compatible

产品线

Opticap® XL 10

特点

hydrophobic

制造商/商品名称

Aervent®

参数

≤24 mL/min air diffusion at 965 mbar (14 psig) and 23 °C (in 70/30%IPA/water)
≤24 mL/min nitrogen diffusion at 970 mbar (14 psig) and 23 °C (in 70/30% IPA/water)
1.0 bar max. differential pressure (15 psid) at 80 °C (Forward)
1.0 bar max. inlet pressure (15 psi) at 80 °C (Forward)
2.8 bar max. inlet pressure (40 psi) at 60 °C (Forward)
25 °C max. inlet temp.
4.1 bar max. differential pressure (60 psid) (Reverse; intermittent)
4.1 bar max. inlet pressure (60 psi) (Reverse; Intermittent)
5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
5.5 bar max. inlet pressure (80 psi) at 25 °C (Forward)
80 psig max. inlet pressure

技术

gas filtration: suitable

长度

13.2 in.

宽度

4.2 in.

纯化柱标称长度

10 in. (25 cm)

直径

10.7 cm (4.2 in.)

过滤面积

0.65 m2

入口接头直径

3/4 in.

入口至出口宽度

33.0 cm (13.0 in.)

出口接头直径

3/4 in.

杂质

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

重量萃取物

≤45 mg/cartridge

基质

Aervent®

孔径

0.2 μm pore size

输入

sample type gas

泡点

≥1100 mbar (16 psig), nitrogen with 70/30% IPA/water at 23 °C

配件

19 mm (3/4 in.) inlet/outlet sanitary flange

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相关类别

一般描述

Device Configuration: 取样皿滤膜

包装

Double Easy-Open bag

质量

Retains Brevundimonas diminuta liquid aerosol for 21 days at a minimum challenge of 10⁷ CFU/cm²

制备说明

Sterilization Method
30 autoclave cycles of 30 min @ 135 °C
This product was manufactured with a PTFE membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

分析说明

Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
HydroCorr: ≤0.75 mL/min @ 2.6 bar (38 psig) per sample
Gravimetric Extractables: after 24 hours in a 70/30% IPA/water mixture at controlled room temperature

其他说明

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 Steam Sterilization & Integrity Testing Procedures guide and first page of Visual Inspection Guide
  • Storage Statement: Store in dry location
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

法律信息

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

免责声明

EMD Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 2014/68/EU of 15 May 2014. This product has been classified under Article 4 § 3 of the Directive 2014/68/EU. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 4 § 3 of the Directive 2014/68/EU, this product does not bear the CE mark.

法规信息

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