Huironhe HRH-MDI10 Fully Automated Metered-Dose Inhaler (MDI) Actuator Tester
| Brand | Huironhe |
|---|---|
| Origin | Beijing, China |
| Manufacturer Type | Authorized Distributor |
| Country of Origin | China |
| Model | HRH-MDI10 |
| Power Supply | 220 V, 50 Hz, 10 A |
| Dimensions (Basic) | 220 mm × 230 mm × 320 mm |
| Dimensions (Shaking Version) | 415 mm × 300 mm × 525 mm |
| Weight (Basic) | ~10 kg |
| Weight (Shaking Version) | ~20 kg |
| Max Actuation Frequency | 2 actuations/s |
| Simultaneous Actuations per Cycle | 2 units |
| Carousel Capacity | 10 MDI canisters |
| Shaking Frequency (optional) | 5–600 rpm |
| Shaking Amplitude (optional) | 40 mm |
Overview
The Huironhe HRH-MDI10 Fully Automated Metered-Dose Inhaler (MDI) Actuator Tester is an engineered platform designed for precise, repeatable, and regulatory-compliant evaluation of pressurized metered-dose inhaler performance. It operates on a programmable mechanical actuation principle—mimicking human hand-actuated valve depression with controlled force, dwell time, and orientation—to deliver consistent metered doses under standardized environmental conditions. This system supports critical pharmaceutical development workflows including dose content uniformity (DCU), spray pattern analysis, plume geometry characterization, and aerodynamic particle size distribution (APSD) sample generation for cascade impaction. Its modular architecture enables integration into inhalation toxicology and pharmacokinetic study setups, particularly where reproducible aerosol generation is required for in vivo (nose-only or whole-body exposure) and in vitro (cell culture exposure chamber) inhalation models.
Key Features
- Programmable dual-actuator mechanism delivering synchronized or staggered actuations at up to 2 Hz, ensuring high-throughput testing without cross-contamination.
- Motor-driven carousel accommodating 10 standard MDI canisters (e.g., 10–20 mL aluminum or coated glass containers), with manual canister swap capability during operation—eliminating workflow interruption.
- Optional integrated shaking module (5–600 rpm, 40 mm amplitude) replicates clinical priming and suspension homogenization prior to actuation, essential for suspension-based formulations.
- Compact footprint (basic configuration: 220 × 230 × 320 mm) optimized for ISO Class 5–7 cleanroom environments and laboratory benchtop deployment.
- Electromechanical actuation system calibrated to apply physiologically relevant valve-depression force (typically 10–15 N) with ±0.2 s timing resolution, meeting USP & Ph. Eur. guidance on MDI testing apparatus qualification.
Sample Compatibility & Compliance
The HRH-MDI10 accommodates all commercially available MDI canisters conforming to ISO 19948:2021 (inhaler testing—requirements for actuator testers) and ASTM D7710-22 (standard practice for evaluating MDI valve performance). It supports propellant-based (HFA-134a, HFA-227ea) and non-propellant (soft-mist) formulations, as well as unit-dose and multi-dose configurations. The system is compatible with gravimetric assay, laser diffraction (Spraytec, Malvern Panalytical), and Andersen Cascade Impactor (ACI) or Next Generation Impactor (NGI) sampling interfaces. Data acquisition and instrument control logs are structured to support GLP-compliant documentation, including audit trails for parameter changes, actuation timestamps, and operator identification—aligning with FDA 21 CFR Part 11 requirements when paired with validated third-party LIMS or ELN software.
Software & Data Management
The HRH-MDI10 operates via embedded firmware with USB/RS-232 connectivity for external PC control. Optional software modules provide protocol scheduling (e.g., 10-canister sequence with pre-actuation shake, dwell, and post-actuation purge), real-time actuation counter display, and CSV export of timestamped event logs (start/stop, shake duration, actuation count per canister). All operational parameters—including frequency, dwell time, shake rpm, and amplitude—are user-configurable and stored with version-controlled settings. When deployed in regulated environments, the system supports electronic signature capture and change control tracking through integration with validated laboratory informatics platforms.
Applications
- Dose content uniformity (USP ) and emitted dose testing across formulation development and stability studies.
- Aerosol generation for in vitro deposition studies using impactors or inertial samplers.
- Preclinical inhalation toxicology: synchronized delivery to nose-only exposure chambers (e.g., CH Technologies) or whole-body systems (e.g., PromethION).
- Comparative bioequivalence assessment of generic MDIs versus reference listed drugs (RLDs).
- Quality control release testing in GMP manufacturing facilities following ICH Q5C and Q5D guidelines.
FAQ
Does the HRH-MDI10 comply with ISO 19948:2021?
Yes—the mechanical actuation geometry, force profile, and timing resolution meet the minimum requirements specified in Clause 6 of ISO 19948:2021 for automated MDI testers.
Can it be used for both solution and suspension MDIs?
Yes—especially when equipped with the optional shaking module, which ensures uniform suspension resuspension prior to each actuation cycle.
Is remote monitoring supported?
Standard firmware includes serial/USB command protocols; custom SCADA or LabVIEW integration is feasible via documented ASCII command set.
What maintenance intervals are recommended?
Actuator pins and carousel bearings require lubrication every 500 operating hours; full calibration verification is advised quarterly or after 1,000 actuations.
Does it support variable actuation delay between canisters?
Yes—inter-canister delay is programmable from 0.5 s to 600 s, enabling staggered dosing protocols for multi-chamber exposure studies.
