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Merck
CN

CTGB74TP3

Millipore

Aerex® Cartridge Filter

cartridge nominal length 40 in. (100 cm), filter diam. 2.7 in. (6.9 cm), Code 7

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UNSPSC代码:
23151806

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物料

polypropylene device
polypropylene support
silicone seal

质量水平

400

特点

hydrophilic

制造商/商品名称

Aerex®

参数

≤60 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 temp. (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)

纯化柱标称长度

40 in. (100 cm)

设备尺寸

40 in.

过滤器直径

2.7 in. (6.9 cm)

过滤器过滤面积

2.6 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)

重量萃取物

≤35 mg/cartridge

基质

Aerex®

孔径

0.2 μm pore size

泡点

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

代码

Code 7

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一般描述

Device configuration: Cartridge
Cartridge type: Gas

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

制备说明

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

Gravimetric Extractables: The extractables level was ≤ 35 mg per 10-inch cartridge after 24 hours in a 70/30% IPA/water mixture at controlled room temperature. 
HydroCorr: ≤ 0.40 mL/min per 10-inch cartridge with water at 1380 mbar (20 psig)

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 to 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

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

法规信息

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