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METHODS

Cleanliness

The cleanliness of components plays a key role in many areas, as it has a significant impact on the quality, safety and reliability of the manufactured intermediate and end products. In medical technology, the slightest conta­mi­nation on or in instruments or implants can endanger the health of patients, for example through infections. In the watchmaking industry, where precision is crucial, dust or production residues can disrupt the functioning of the end product and thus impair accuracy and longevity. In the machine industry, contamination leads to increased wear, corrosion or malfunctions, which reduces the service life of machines and can lead to costly breakdowns.

In order to ensure the required purity of a test object, we use highly specialized analytical techniques that allow us to precisely examine the material composition and product surfaces.

It can be measured either directly on a medical device or indirectly by extraction and subsequent analysis of the extract. Direct measurement (e.g. by XPS, FT-IR or EDX) often requires minimal sample preparation, but is localized and may not be sufficiently representative. Extraction, on the other hand, enables the quantification of a total amount of impurities (e.g. using GC-MS, TOC, TN or ICP-MS). In addition, impurities in the form of particles can be classified and quantified after filtration (more information can be found here).

By using these analytical methods, high product quality is ensured and potential impurities are detected at an early stage. This makes a significant contribution to ensuring that the high-quality end product is reliable and safe and that the requirements for cleanliness and functionality are met.

You can find more information on the topic of cleanliness / purity of medical devices here.

According to which standards do we test?

Whenever possible, we carry out our testing services in accordance with or based on these international standards:

  • ISO 19227 (TOC, ICP-MS)
  • Method-specific standards, depending on material and question

Which devices do we use?

  • Thermo GC-MS/MS: Trace GC 1310 coupled to a TSQ 9000 mass spectrometer
  • FT-IR (Fourier Transform Infrared Spectrometry): FT-IR Microscope Bruker Lumos
  • XPS (X-ray photoelectron spectroscopy): Kratos axis Nova
  • ICP-MS (Inductively Coupled Plasma Mass Spectrometry): Agilent 7700x ICP-MS
  • TOC (Total Organic Carbon), TIC (Total Inorganic Carbon), TN (Total Nitrogen): Shimadzu TOC-L Analyzer
  • SEM/EDX (scanning electron microscopy with energy dispersive X-ray spectroscopy): Zeiss Sigma 300 VP with UltimMax 40 EDX detector
  • Miele G 7836 CD Washer-disinfector

What experimental possibilities are there?

Various options for cleanliness analyses are available, for example:

What you should know about this method?

Which products can be tested at the RMS?
>We test all products. Contact us and we will discuss your individual problem<
Are the methods accredited?

RMS is an ISO/IEC 17025 accredited analytical laboratory (accreditation type C). Many of the analyses are already validated. New or customer-specific analysis methods can be validated and accredited by us.

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Who is your contact person?

Ronny Wirz
Dr. sc. ETH Zurich
Senior Scientist
+41 32 644 2052