Foreign body contamination in intravenous drug products

Foreign, undissolved material are commonly reported in parenteral solutions. RSSL was asked to inspect a series of vials containing pharmaceutical drugs with suspected contamination, identified during the client’s QA screening processes

Background

Foreign, undissolved material are commonly reported in parenteral solutions.  RSSL was asked to inspect a series of vials containing pharmaceutical drugs with suspected contamination, identified during the client’s QA screening processes

Approach

The vials were initially triaged; i.e. they were inspected and particles, if present, were located, photographed and measured in situ  (Figure 1) without accessing the contents of the vials.  Identified particles were grouped based on common optical features.  Results of this initial investigation were reported to the client.

The client then reviewed the data and relevant vials were selected for further analysis.  Particles were isolated and analysed by compound light microscopy, Fourier transform infrared (FT-IR) spectroscopy (Figure 2)  and X-ray microanalysis (Figure 4). 

Results

The data demonstrated that a large number of the particles in the vials had originated from the rubber stoppers.  The client was then able to successfully address and resolve this contamination concern by liaising directly with their stopper supplier. 


Figure 1 - Micrograph of the foreign particle in the
drug product, imaged in situ.
Figure 2 - FT-IR spectrum of the particle (red) compared
with reference  spectra of butyl rubber (blue)
and siliceous material (green and grey).

   
Figure 3 - Backscattered electron image of a
subsample of the foreign particle; the ‘bright’ specks
corresponded with material (siliceous minerals) of a
higher atomic weight.
Figure 4 - X-ray microanalysis spectral overlay typical of the
particle isolated from the vial (solid red and blue outline).

Foreign body contamination in intravenous drug products

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