BRS 100i Breathing Simulator
The BRS 100i is specifically designed for generating neonatal, infant, child and adult breathing patterns required for dose uniformity testing of nebulisers in accordance with ISO 27427:2013. It can also be used to generate the profiles required in USP <1602> for testing ‘Spacers and Valve Holding Chambers used with Inhalation Aerosols’.
Ph. Eur. 2.9.44, USP <1601>, <1602> and ISO 27427:2013 compliant
Intuitive, touchscreen user interface
Extensive data output options
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BRS 100i Technical Specifications
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Volume (manually adjust):
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0 to 800 mL
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Frequency:
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12 – 40 bpm
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I:E ratio:
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1:1, 1:2 or 1:3
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Waveforms:
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Sinusoidal
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Patient profile suitability:
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Neonate/Infant, Child, Adult
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Profile:
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Inhalation and Exhalation
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Start:
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Select start on inhalation or exhalation stroke
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User interface:
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Touchscreen
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Uses:
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Testing Nebulisers (Ph. Eur. 2.9.44 and USP <1601> Testing MDIs with Spacers/VHCs (USP <1602> Improving IVIVCs for MDIs with Spacers/VHCs and nebulisers: With Filter Holder and Adapter (Dose Uniformity) With Impactor and Mixing Inlet (APSD)
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Top Tip
The BRS 100i breathing simulator can also be used in place of a standard vacuum pump with a cascade impactor such as the NGI or ACI and a Mixing Inlet to form a simple and inexpensive system for APSD studies utilising more representative patient profiles for MDIs with and without a spacer/VHC.
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MDI aerosol characteristics are relatively insensitive to changes in air flow rate because the aerosolisation and dispersion mechanisms are dependent on the force generated by the propellant, rather than the patient’s inspiratory effort. Therefore, for MDIs, the test flow rate is fixed at an arbitrary value of 28.3 L/min. A vacuum pump is used to draw air through the assembled test set-up at this flow rate. However, these test conditions are not applied for DDU testing when the MDI is intended for use with an add-on device such as a spacer or valved holding chamber (VHC).
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The delivered dose testing of nebulisers is carried out to determine the total amount of drug a patient might be expected to receive during a treatment period, rather than through one inhalation. Given the mode of operation of nebulisers, well-defined tidal breathing profiles for specific patient types are specified for testing. The two tests specified in the Pharmacopoeias to characterise delivered dose, Active Substance Delivery Rate and Total Active Substance Delivered, are based on tidal flow conditions generated by a breathing simulator, as opposed to fixed flow rates.
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