Product overviewThe BRS 200i is a breathing simulator for in‑vitro testing of nebulisers and metered‑dose inhalers (MDIs) used with spacers/valve holding chambers (VHCs). It reproduces standard sinusoidal patterns (Ph. Eur., USP) and user-defined flow vs time profiles to measure drug delivery rate and tidal drug delivered, supporting improved in‑vitro/in‑vivo correlations (IVIVCs). The instrument covers a wide range of patient physiologies including infant and neonate volumes.
Key features- 21 CFR Part 11 compliant
- Stores and recalls test methods
- Improved accuracy for infant and neonate volume requirements
- Extensive data output and export options
- Integration with the Vertus® III range for automated shake, fire and flow control in breath profile testing
- Automatic data backup and report printing for enhanced workflow
User interface and method handling- Touchscreen user interface with user log-in
- Pre-defined compendial breathing pattern selection
- Custom creation and editing of breathing pattern methods (flow vs time)
- Main run screen displaying ready-to-test status and test progression
ApplicationsIn‑vitro testing of nebulisers to Ph. Eur. 2.9.44 and USP <1601>; testing MDIs with spacers/VHCs per USP <1602>; supporting IVIVC studies for MDIs with spacers/VHCs and nebulisers (compatible with filter holders for dose uniformity and with impactor/mixing inlet configurations for APSD studies).
Specifications / technical data- Model: BRS 200i
- Volume range: 0 to 900 mL
- Frequency: 6 – 60 bpm
- I:E ratio: Variable
- Waveforms: Sinusoidal, Square, Triangular, User-defined (flow vs time)
- Profile modes: Inhalation and/or Exhalation
- Start options: On inhalation or exhalation stroke; supports user-defined start in custom profiles
- User interface: Touchscreen with user login
- Primary uses: Nebuliser testing (Ph. Eur. 2.9.44, USP <1601>), MDI with Spacer/VHC testing (USP <1602>); support for IVIVC studies with filter holders or impactor/mixing inlet configurations