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Particle Characterization in Pharmaceutical Applications

 

Compendial Methods and MFI

For finished products, US Pharmacopeia (USP), European Pharmacopeia (PhEur) and Japanese Pharmacopeia (JP) specify the protocols, equipment and acceptable limits for sub-visible foreign particulate mater in parenterals, specifically in the  ≥ 10µm and ≥ 25µm size ranges. The respective web sites are www.usp.org,  www.pheur.org, www.sjp.jp. These individual methods have recently been harmonized across all three jurisdictions.
 
The prescribed, harmonized limits are:

 For parenteral infusion or solutions for injection supplied in containers... 

 Particles ≥ 10µm

 Particles ≥ 25µm

 > 100 ml 

 < 25 per ml 

 < 3 per ml

 < 100 ml

 6000 per container 

 600 per container

Since these methods were first developed, advances in detection technology and analytical methods for enumerating sub-visible particles have emerged.  One technique that provides measurable benefits for the parenteral drug industry is a flow microscopy technology like Micro-Flow Imaging or MFI. 

MFI is based on an imaging platform and offers two distinct advantages for measuring parenteral particles:

  1. MFI is more sensitive for detecting and measuring near-transparent particles like protein aggregates (see results from the analysis of a bio-pharmaceutical below)
  2. MFI uses particle images to provide visual and morphological information on particles.

Particle Analysis in Parenterals - Compendial MethodsAlthough flow microscopy methods such as MFI are not specified in the respective Pharmacopeia chapters, MFI can be used as a substitute technology since it can be demonstrated to be compliant with the respective standards. Please contact Brightwell for more information or a copy of the results from validation experiment with the appropriate Reference Standards.

How Does MFI Work? MFI captures images of suspended particles in a fluid sample. Images are displayed on the system monitor in real-time and are analyzed to produce a particle database including count, size, transparency and shape parameters. Morphology-based software filters can be created and applied to this database to produce particle size distributions and isolate sub-populations. Native images are also stored for further investigation and analysis.