Particle size measurement in intravenous fluids

Area of Science:

• Pharmaceutical science
• Analytical chemistry
• Materials science

Background:

• Particulate contamination is a critical quality attribute in pharmaceutical injections.
• Accurate measurement of particles is essential for product safety and efficacy.
• Existing methods for particle analysis may yield differing results.

Purpose of the Study:

• To compare particulate contamination levels in large volume injections using two distinct techniques.
• To investigate the correlation and discrepancies between electrical resistance and light blockage methods.
• To understand the underlying reasons for observed differences in particle quantification.

Main Methods:

• Measurement of particulate contamination in various large volume injection formulations.
• Utilized electrical resistance (Coulter) technique for particle sizing and counting.
• Employed light blockage (HIAC) technique for particle sizing and counting.

Main Results:

• Significant variations in particle counts were observed between Coulter and HIAC techniques.
• A correlation was found for ionic solutions, but not for sugar-containing solutions.
• Discrepancies could not be solely attributed to shape factors, indicating fundamental physics differences.

Conclusions:

• Results from electrical resistance and light blockage methods are not directly interchangeable.
• The choice of technique significantly impacts particulate contamination assessment, particularly for complex solutions.
• Further investigation into the physics of each technique is warranted for accurate interpretation.