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). - Two separate, independently controlled test spaces: one compartment for conditioning the impactor and one for conditioning the nebulizer or inhaler
- Interface port and adjustable shelf allow interface with the Next Generation Impactor (NGI) and the Andersen Cascade Impactor (ACI) with or without separators
- Temperature and humidity conditioning within the nebulizer/inhaler compartment simulates the product being used in various environments
- Air circulation in each compartment for precise temperature and temperature/ humidity uniformity
- Insulated stainless steel walls minimize heat leak to deliver more accurate results
- 8200 Programmer Controller, with a high resolution 7-inch color touch widescreen display, is able to program each compartment independently, easily giving the technician the ability to run several simulations with different variables
- Arm ports with iris closures provide complete reach-in access to the interior compartments without upsetting control setpoint conditions
- Large viewing windows and interior lighting provide excellent visibility for monitoring
- Casters are incorporated for mobility, allowing the chamber to be easily moved around the laboratory
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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