MDI
Globally compliant pressurized metered-dose inhalers (pMDIs) with USP/EP-certified materials, precise 1–5μm lung-targeted aerosol, child-safe features, and GMP sterile production—ideal for asthma, COPD, and respiratory therapies worldwide.
Our pressurized metered-dose inhaler (pMDI) system is engineered to meet the highest global pharmaceutical standards for safety, precision, and patient compliance in respiratory therapy. Every component that contacts the drug formulation—valve stem, seals, and canister interior—is manufactured from USP Class VI, EP, and ISO 10993-1 certified materials, ensuring zero heavy metal or phthalate migration.
The device uses environmentally safe propellants (HFA-134a/HFA-227ea), fully compliant with FDA and EMA regulations and ozone-friendly. Produced under strict GMP conditions with EO or γ-ray sterilization, it achieves a Sterility Assurance Level (SAL) of 10⁻⁶, critical for pulmonary delivery. Each batch undergoes rigorous dose uniformity testing (RSD ≤6%) per Ph.Eur. and USP guidelines, guaranteeing ±5% dose accuracy (typically 25–100μg per actuation).
Aerosol performance is optimized for deep lung deposition: particle size (MMAD) is tightly controlled at 1–5μm, achieving ≥30% lung deposition while minimizing oropharyngeal residue. Spray velocity (30–50 m/s) balances rapid dispersion with patient breathing coordination. Low dead volume (<5μL) and anti-residue valve design ensure consistent dosing from first to last puff.
Clinically versatile, it supports solution, suspension, and emulsion formulations—including β₂-agonists and corticosteroids—in 10ml (60 doses) to 20ml (120 doses) aluminum canisters. Features include tamper-evident foil seals, child-resistant locks, dose counters, and compatibility with spacers for pediatric/elderly use. The lightweight (≤30g), non-slip, drop-tested (1.5m) design enhances portability and usability.
With clear labeling, audible “click” feedback, and optional inhalation flow indicators, the pMDI significantly lowers the barrier to correct use—making it a trusted choice for global respiratory care.
| Category | Specifications / Features |
|---|---|
| Regulatory Compliance | USP Class VI, EP 3.1, ISO 10993-1, FDA, EMA, Ph.Eur., ICH Q3D |
| Propellant | HFA-134a or HFA-227ea (CFC-free, ozone-safe) |
| Sterilization & SAL | EO or γ-ray sterilization; Sterility Assurance Level (SAL) = 10⁻⁶ |
| Dose Accuracy | ±5% per actuation; RSD ≤6% (per Ph.Eur./USP) |
| Aerosol Particle Size (MMAD) | 1–5 μm (optimized for bronchial & alveolar deposition) |
| Lung Deposition Rate | ≥30% |
| Spray Velocity | 30–50 m/s |
| Dead Volume | ≤5 μL |
| Canister Material | Medical-grade aluminum, pressure-rated ≥1.8 MPa |
| Temperature Range | Stable from -20°C to +50°C |
| Drop Test | Survives 1.5m free fall without leakage or damage |
| Capacity Options | 10ml (60 doses), 15ml, 20ml (120 doses) |
| Drug Compatibility | Solutions, suspensions, emulsions (e.g., salbutamol, budesonide, fluticasone) |
| Child Safety | Optional child-resistant lock mechanism |
| Tamper Evidence | Sealed aluminum foil cap – irreversible upon opening |
| Traceability | Full batch traceability with Certificate of Analysis (CoA) |
| Patient Features | – Weight ≤30g – Actuation force: 300–400g – Audible “click” – Non-slip texture – Dose counter window |
| Usage Guidance | Visual instructions + optional inhalation flow monitor (≥3 sec吸气) |
| Shelf Life | 2–3 years (stored in cool, dry, dark conditions) |
| Production Compatibility | High-speed automated filling (≥200 units/min); dual-chamber option for combination therapy |