Pharmaceutical Applications
Visible Particle Detection
Visible particles (those greater than approximately 50µm) in finished products are normally detected through visual inspection of the end-product by trained operators under controlled conditions. There are ongoing efforts to partially or completely automate this process and there is a Visible Particle Interest Group in the Parenteral Drug Association www.pda.org.
Analysis of FDA 483 results (www.fda.gov) for the past 8 years reveals that the presence of visible particulates is consistently one of the top 10 reasons for product recalls (Source: J. Famulare, 2006 PDA/FDA Joint Regulatory Conference).
MFI can be used as a diagnostic tool to identify, measure and classify visible particles. This is crucial to determine the particle characteristics and origin which ultimately result in corrective measures to eliminate the particles altogether.
The benefits of MFI for the measurement of visible particles are its speed, simplicity and quantitative results. The use of morphology-based software filters can also help detect and identify air bubbles, silicone droplets and contaminants.
