Unknown particles in your pharmaceutical products : from emergency to continuous monitoring

Identification of unknown particles : from an emergency intervention...

Friday 8:05am, the head of quality control from one of our longstanding clients contacts us : their team had been noticing the formation of particles over the last few days, seemingly randomly in a whole batch of products, brining production to a halt while an investigation was underway. Their internal investigation did not manage to identify the origin of these pollutants and no changes in the production process seemed to be leading to any kind of resolution.

External contamination ? Container/Contents interaction ? Was the product aging ? Upon receiving samples, we filtered out and isolated the unknown particles. These particles were then subjected to a general diagnostic using our laboratory’s technical facilities :

  • Observation under a Scanning electron microscope, coupled to an EDX probe : this technique allowed us to assess the chemical and morphological homogeneity of the particles and to run a primary diagnostic on their composition. We found that they were organic in origin.
  • Fourier transform infrared microscopy (FTIR and µ-FTIR) was then used to identify the nature of the chemical bonds constituting the particles.
  • Finally, chromatography techniques such as GC-MS were used to produce a qualitative summary of the molecules making up the particles 

The quick and efficient execution of all these complementary techniques helped our client to reach a conclusion on the nature of the particles in less than 24 hours : they were made of cellulose.

… to personalized support with reliable and sustainable results.

This information, although crucial, was not sufficient for our client to deduce the origins of these pollutants and to put an immediate plan into place to remedy the situation.

« To see past the analysis», was our original slogan.

We then organized for one of our specialists to perform an onsite audit. The aim of this process was to get a better understanding of the environment in which the particles were appearing, and of the different elements being used during the production process which would likely explain the source of the cellulose.

After a daylong intervention, speaking with different teams and studying the different production steps, we came up with the hypothesis that these particles were coming from paper towels used during the production process. This hypothesis was quickly verified by performing a comparative expertise of the cellulose fibers of the paper towels and the particles filtered out of the product.

Our teams then assisted the client in implementing improvements in their production procedures including the use of better suited sampling techniques, without the risk of releasing particles.

Even given the challenges involved, this process was carried out in such a short timeframe thanks to the responsiveness of our laboratory. But beyond the turnaround time, we strive first and foremost to provide our clients with reliable and meaningful analysis that take into account the particular circumstances and requirements of our clients, and that can easily be turned into straightforward and practical solutions.

To ensure the quality of products in the event of non-compliance is one of the major challenges that pharmaceutical industrialists must face

Cleanliness with regard to particulate matter is a crucial requirement throughout the whole lifecycle of a pharmaceutical product. The evaluation of cleanliness is done by implementing regular inspections and by optimizing production procedures to reduce the risk of contaminations.

Our goal is to assist you in optimizing your inspection procedures by providing timely services with high added value (advanced techniques, complementary equipment, similar experiments). If you wish to know more about our services, contact us via email at contact@filab.fr  !

Caroline KURZAWA
Caroline KURZAWA R&D Project Engineer
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