Product category:
Mechanical testing equipment
News Release from: Copley Scientific | Subject: BRS 1000
Edited by the Laboratorytalk Editorial
Team on 06 July 2007
Nebuliser testing boosted by simulated
breathing
Copley's breath simulator BRS 1000 is a microprocessor-controlled instrument that generates an air flow profile which simulates adult tidal breathing
Copley Scientific has launched a new breath simulator that is designed to generate the breathing profiles now required for testing pharmaceutical nebulisers A recent European Medicines Agency (EMEA) guidance highlights the importance of characterising nebuliser performance in terms of drug output and particle size distribution for the purposes of determining safety and efficacy
This article was originally published on Laboratorytalk on 21 May 2007 at 8.00am (UK)
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Based on work performed by the European Pharmaceutical Aerosol Group (Epag) an associated monograph is currently under review for inclusion in the European Pharmacopoeia (2.9.44 Preparations for Nebulisation: Characterisation).
The sinusoidal waveform and 1:1 inhalation/exhalation ratio of the Copley breath simulator BRS 1000 specifically conforms to the draft monograph.
The system has a tidal volume of 500ml, and variable frequency from 10 to 25 breaths per minute.
Tests can be based on cycle number (1 to 9999 breaths) or cycle time (0 to 8 hours).
A simple user-interface with menu-driven operation is accessed via a membrane keypad.
Conventionally, nebulisers and the drugs that they deliver have been tested as separate entities, with nebuliser testing conducted according to European Committee for Standardisation EN 13544-1.
The EMEA's unprecedented introduction in 2006 of regulatory guidance on nebulisers recognises that overall performance depends on both device and drug.
The new regulations make nebuliser testing more consistent with current practise for other inhalation delivery platforms.
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