Medical-Grade Aerosol Dispenser Valve for Sterile Nasal Sprays with Antimicrobial Housing
Product Description
Meeting stringent pharmaceutical standards, this GMP-compliant aerosol dispenser valve ensures aseptic delivery of saline solutions, corticosteroid mists, and vaccine adjuvants. The silver-ion impregnated polycarbonate housing inhibits bacterial growth (99.9% per USP <51>), while the laser-drilled nozzle produces 10-15µm particles for deep sinus penetration. Features include a dosage counter, child-resistant lock, and tamper-evident seal. Validated for ethylene oxide and gamma sterilization, it’s ideal for OTC nasal decongestants, allergy relief sprays, and pandemic-response intranasal vaccines.
Bullet Points
✔️ Precision 25µl ±5% per actuation dosing
✔️ Integrated particulate filter (0.2µm sterile vent)
✔️ Meets FDA 21 CFR 210/211 & EU Annex 1
✔️ 360° spray angle for non-directional administration
✔️ Stability tested for 36 months at 25°C/60% RH
Specific Application Scenario
Delivering mRNA-based nasal vaccines in mobile immunization clinics.
Component | Part Description |
1. Mounting Cup | Clear lacquer coated tinplate |
2. Outer Gaske | Buna |
3. Inner Gasket | Buna |
4. Stem | An alloy of zinc , titanium, magnesium, Aluminum .etc |
5. Spring | Stainless steel |
6. Housing | PA. Tail Orifice f2.40mm Natural color |
7. Red cover | PP |
FAQ
Q1: Extractables/leachables profile?
A: Complies with USP <661.1> and <1663> protocols.
Q2: Maximum vial pressure compatibility?
A: 8 bar (116 psi) sustained pressure resistance.
Q3: Sterilization validation support?
A: Provided IQ/OQ/PQ documentation packages.
Q4: Compatible with protein-based biologics?
A: Yes, low-shear design preserves molecule integrity.
Q5: Lead time for clinical trial batches?
A: 10-12 weeks with full traceability documentation.