Aervent^?CTGR Cartridge Filter

半岛bd体育手机客户端 说明

一般描述

Device Configuration: Cartridge

特点和优势

Rated for aerosol retention of a total challenge of 108–1010 plaque forming units of ΦX-174 virus particles at 85 Nm3/h (50 SCFM) per cartridge.

包装

Double Easy-Open bag

质量

RetainsBrevundimonas diminutaliquid aerosol for 21 days at a minimum challenge of 10? CFU/cm?

制备说明

Sterilization Method
150 (100 forward/50 reverse) SIP cycles of 30 min @ 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: after 24 hours in a 70/30% IPA/water mixture at controlled room temperature
HydroCorr: ≤0.75 mL/min @ 2.6 bar (38 psig) per 10 in cartridge
Bacterial Retention
Samples were quantitatively retentive of a minimumBrevundimonas diminutachallenge concentration of 1 x 10? CFU/cm? using ASTM^?F838 methodology.

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

基本信息

eCl@ss

32031690

半岛bd体育手机客户端 性质

质量水平	400
物料	PTFE polypropylene polypropylene support silicone seal
特点	hydrophobic
manufacturer/tradename	Aervent?
参数	≤24 mL/min nitrogen diffusion at 970 mbar (14 psig) and 23 ℃ (in 70/30% IPA/water) 1.7 bar max. inlet pressure (25 psi) at 80 ℃ 1.8 bar max. differential pressure (25 psid) at 80 ℃ (Forward) 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 ℃ (Forward) 5.5 bar max. inlet pressure (80 psi) at 25 ℃ (Forward)
cartridge nominal length	10 in. (25 cm)
直径	6.9 cm (2.7 in.)
过滤面积	0.65 m2
总尺寸	10 in.
杂质	<0.25 EU/mL USP bacterial endotoxins (LAL test, aqueous extraction)
gravimetric extractables	≤35 mg/cartridge
基质	Aervent?
孔径	0.2 μm pore size
input	sample type gas
bubble point	≥1100 mbar (16 psig), nitrogen with 70/30% IPA/water at 23 ℃
cartridge code	Code 7