Quality control (QC) and stability studies ensure that aerosol products remain safe, effective, and consistent throughout their shelf life.
Quality Control Measures:
Raw Material Testing: Verification of the identity, purity, and potency of APIs, propellants, and excipients.
In-Process Controls: Monitoring of fill volume, weight, and pressure during manufacturing.
Final Product Testing: Includes assays for dose uniformity, particle size, spray pattern, and valve performance.
Microbial Testing: Ensuring that the product remains within acceptable microbiological limits.
Stability Studies:
Objective:
To evaluate how the product withstands various environmental conditions (temperature, humidity, light) over time.
Protocols:
Real-Time Stability: Products are stored under recommended conditions and tested at regular intervals.
Accelerated Stability Testing: Elevated temperatures and humidity levels are used to predict long-term stability in a shortened timeframe.
Parameters Monitored:
Physical Stability: Changes in the aerosol plume, phase separation in suspensions, or changes in viscosity.
Chemical Stability: Degradation of the API or other formulation components, changes in pH, and formation of impurities.
Propellant Stability: Ensuring that propellant pressure remains consistent and that no interactions compromise the container integrity.