Merck
CN
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CTGB73TP3

Millipore

Aerex CTGB 筒式过滤器 30 in.0.2 µm 7 号

pore size 0.2 μm, cartridge nominal length 30 in. (75 cm), Code 7

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别名:
Aerex® 0.2 µm小柱
eCl@ss:
32031690

物料

PTFE
polypropylene
polypropylene support
silicone seal

质量水平

400

无菌性

non-sterile

sterilization compatibility

steam-in-place compatible

产品线

Aerex®

特点

hydrophobic

manufacturer/tradename

Aerex®

参数

≤45 mL/min nitrogen diffusion at 690 mbar (10 psig) and 23 °C (in 60/40% IPA/water)
0.35 bar max. differential pressure (5 psid) at 145 °C (Forward)
0.35 bar max. inlet pressure (5 psi) at 145 °C (Forward)
1.7 bar max. differential pressure (25 psid) at 80 °C (Forward)
1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward)
5.2 bar max. differential pressure (75 psid) at 25 °C (Reverse; intermittent)
5.2 bar max. inlet pressure (75 psi) at 25 °C (Reverse)
6.9 bar max. differential pressure (100 psid) at 25 °C (Forward)
7 bar max. inlet pressure (100 psi) at 25 °C (Forward)

technique(s)

gas filtration: suitable

长度

30 in.

宽度

2.7 in.

cartridge nominal length

30 in. (75 cm)

直径

6.9 cm (2.7 in.)

过滤面积

1.95 m2

杂质

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

gravimetric extractables

≤105 mg/cartridge

基质

Aerex®

孔径

0.2 μm pore size

input

sample type gas

泡点

≥900 mbar (13 psig), nitrogen with 60/40% IPA/water at 23 °C

柱代码

Code 7

相关类别

一般描述

Device Configuration: Cartridge

特点和优势

This product has been qualified to retain a ΦX174 virus aerosol challenge of 10⁸ to 10¹⁰ PFU at an air flow rate of 50 SCFM per 10-inch cartridge after 50 steam-in-place cycles at 145 °C.

包装

Double Easy-Open bag

其他说明

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

质量

The membrane has been qualified to retain bacteria when challenged for 21 days with a minimum Brevundimonas diminuta aerosol concentration of 1 x 10⁷ CFU/cm².

制备说明

Sterilization Method
200 (150 forward/50 reverse) SIP cycles of 30 min @ 145 °C; SIP up to 165 hours in forward direction @ 145 °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

HydroCorr: ≤0.40 mL/min per 10-inch cartridge with water @ 1380 mbar (20 psig)
Gravimetric Extractables: after 24 hours in a 70/30% IPA/water mixture at controlled room temperature

法律信息

AEREX is a registered trademark of Merck KGaA, Darmstadt, Germany

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