Optimizing a method for detecting contaminants in a drug product is critical, and Joe Gecsey, business development manager of life sciences for Hach Ultra Analytics, discussed an approach taken for an inhaled drug product at his presentation, “Analysis of Particle Size and Distribution in a CFC-Free Aerosol Based Pharmaceutical Preparation,” at Interphex.
The goal of the project, outlined Gecsey, was to determine the presence of any contaminants using particle-size analysis based on light obscuration for an inhalant in an aluminum container that used hydrofluoroalkane as a propellant. The project wanted to detect if there were any contaminants present in the the dose that would alter the dose itself, would create mechnical blockage of the drug’s flow, or affect the dose in any way that would produce an inconsisent dose.

Although microscopy may be used for detecting contaminants, this method has certain disadvantages in terms of the time to perform the test and conduct the analysis and its dependence on the skill of the analyst in detecting the particles.

Using an optical particle counter based on light obscuration, it was possible to detect the particles and count the number of particles in sizes as low as 1.4 microns. The advantages of the approach was reduced time for testing, consistency of results, immediate data availability, and having a method that was independent of the technician’s skill level.

What type of methods do you use or suggest to use in detecting contaminants in inhaled drug products? Leave your comment below