Ensuring the highest standards in the medical industry is crucial, especially when it comes to medical devices and pharmaceuticals. A critical aspect that requires special attention is the inherent, intrinsic or extrinsic contamination with particles.

Particle contamination of medical devices and pharmaceuticals

New scientific demands and questions in the field of quality assurance (QA) are constantly being raised in companies. In addition to the biological and chemical quality requirements for a medical device or medicinal product, physical tests are increasingly being used to improve product quality. Medical device contamination with particles in the size range of 2 µm and above can have far-reaching health consequences for the patient. For example, they can cause superficial phlebitis (inflammation of the veins) when administered intravenously. However, this risk can be significantly reduced by using inline filters. The origin of the particles usually determines the clinical picture; for example, talc or cotton threads can cause granuloma if they get into the patient. The risk of an endothelial reaction increases with longer infusions in particular. Contamination with particles can lead to serious complications and even death, particularly in intensive care patients and children.

For the purely quantitative determination of particulate contamination, a distinction is usually made between two ranges, which, however, have slight differences in size classification depending on the standard:

  • Visual, visible area
  • subvisual, non-visible area

In principle, a particle size from 25 µm to 50 µm can be referred to as the visible particle size range. The particle size range in the related particle contamination standards starts at a minimum of ≥ 2 µm. Particles < 1 µm are influenced by Brownian motion and therefore cannot be detected, especially in their liquid state, which is why they are not considered in the relevant standards.

We offer you three different test methods for the quantitative particle contamination of your product:

  • Visual inspection of the closed, filled container for visible particles
  • Sub-visual control of extraction/rinsing medium or injection/infusion liquid using the direct light blockade method (≥ 2 µm)
  • Sub-visual inspection using the indirect method of overhead microscopy of filtered extraction/rinsing medium or injection/infusion fluid (≥ 10 µm)


Medicinal products:

  • USP 787, USP 788, USP 789
  • EU 2.09.19
  • USP 790,
  • EU 2.9.20

Medical devices:

  • DIN EN ISO 15747
  • DIN EN ISO 8871-3
  • DIN EN ISO 8536-4
  • DIN EN ISO 8536-5
  • DIN EN ISO 8536-8
  • DIN EN ISO 8536-9
  • DIN EN ISO 8536-10
  • DIN EN ISO 8536-11
  • DIN EN ISO 8536-13
  • VDI 2083 Sheet 21

If you have any questions about the appropriate examination, please contact
to us.
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