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標題: Impactor Test Chamber [打印本頁]

作者: weapig    時間: 2010-5-24 15:25     標題: Impactor Test Chamber

The Thermotron Impactor Test Chamber is a sophisticated, dual-compartment environmental enclosure. It enables the study of effects that various environmental conditions, impactor temperatures, and flow rates have on nebulizer and inhaler performance. The Chamber makes it possible to perform drug dispensement studies under carefully and accurately controlled temperature and humidity conditions according to global test standards.



New Guidelines, New Solution
The European Pharmaceutical Aerosol Group (EPAG) and the US Pharmacopeia (USP) Aerosol Expert Committee recommend revising a testing approach for nebulizers. These proposed revisions highlight the negative effect evaporative loss can have on accuracy. Impactor related heat loss can cause evaporation and loss of solvent, which reduces droplet size and results in an artificially low particle size measurement. The Thermotron Imactor Chamber cools the impactor in a controlled environment and/or encloses the inhaler device in a temperature and humidity conditioned environment and therefore, reduces the potential for evaporation of aqueous droplets after aerosolization and improves accuracy. The chamber can host multiple impactors for pre-conditioning, potentially reducing time required for receiving FDA approval.
Features

Nebulizer/Inhaler Compartment (left) & Impactor Compartment (right)
By developing the Impactor Test Chamber in conjunction with a leading pharmaceutical manufacturer, Thermotron designed several features not available in the past to test Orally Inhaled and Nasal Drug Products (OINDPs).
Impactor Chamber Specifications
Workspace Dimensions
Impactor Compartment:28"w x 20"d x 25"h/
71 cm x 51 cm x 64 cm
Nebulizer/Inhaler Compartment:20"w x 20"d x 25"h/
51 cm x 51 cm x 64 cm
Exterior Dimensions:81"w x 27"d x 77"h/
206 cm x 69 cm x 196 cm
Electrical Requirements
Power:208 volt/3 phase/60 hz
Recommended Minimum Service:40 Amps
Water Requirements
Volume:1 gallon/hr
Temperature Range
Impactor Compartment:0°C to +40°C / 31°F to 104°F
Nebulizer/Inhaler Compartment:0°C to +40°C / 31°F to 104°F
Humidity Range
Nebulizer/Inhaler Compartment:30% to 90% RH





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