Foreign body contamination in intravenous drug products

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

Our 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). 

SEM1 RD 4311 HR

 

Figure 1 - micrograph of the foreign particle in the drug product.

 

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).

 

The 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.

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