The requirements for medical devices in terms of risk management, purity and biocompatibility have increased continuously in recent years. We are happy to support you with regard to regulatory obligations (EU-MDR) and normative requirements (DIN EN ISO 10993).
The regulatory demands for manufacturers and distributors of medical devices nowadays are very extensive with regard to the materials used (chemical characterisation), the cleaning process (validated procedures), biocompatibility (qualified screening procedures, Leachables&Extractables) or the documentation on the life cycle of the products (aging tests).Â
We have been determining sterilization residues (EO, ECH Formula) according to DIN EN ISO 10993-7 for well-known European and international manufacturers for many years.
Thanks to our extensive, chemical-analytical portfolio and the expertise of our employees, we develop tailor-made solutions with you for your product, in order to meet these requirements at the best possible price-performance ratio.
We can offer you the determination of organic sum parameters mentioned in the ISO 19227, such as TOC (GC-WLD method according to Ph. Eur.) and THC (GC-FID method according to DIN EN ISO 9377), with methods that are used and accepted by national and international authorities.
Total organic carbon TOC
Ph. Eur. 10, 2.2.28 – Gas Chromatography [accredited method: PL-19422-01]
The TOC-value is a sum parameter representing water-soluble organic  components. It is determined by oxidizing organic components to carbon dioxide (CO2) and subsequently analyzing the CO2 via GC-TCD.         Â
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A typical relative measurement uncertainty is ±10%.
Gas chromatography coupled with Flame Ionization Detector GC-FID
Ph. Eur. 10, 2.2.28 – Gas Chromatography [accredited method: PL-19422-01]
This is the most sensitive method to analyze known components in complex mixtures. The high linearity provided by the FID in this system makes it suitable for quantitative work.
A typical relative measurement uncertainty is ±10%.
The measurement of inorganic parameters (e.g. salts, elemental impurities) using ion chromatography and ICP-MS is also one of our core business areas of expertise.
Ion Chromatography IC
The Ion Chromatography is the method of choice to detect inorganic ions sensitively. After separation single ions are detected due to their conductivity.
A typical relative measurement uncertainty is ±10%.
Inductive coupled plasma mass spectrometry ICP-MS
ICP-MS is one of the most sensitive methods in inorganic trace analysis. Qualitative as well as quantitative analysis of almost all metals and metalloids in solution can be carried out at the same time. For quantification, selected elements are measured against a certified standard. For survey measurements a semi-quantitative program is used.
A typical relative measurement uncertainty is ±10%
The entire scope of the methods mentioned in DIN EN ISO 10993-18:2021 for the determination of SVOC, VOC, NVOC is possible with us.
Gas Chromatography coupled with Mass Spectrometry GC-MS
Ph.Eur. 10,2.2.28 - Gas Chromatography [accredited method: PL-19422-01]
This is the most sensitive method to analyze single components in complex mixtures. But only organic substances which can be vaporized without decomposition can be analyzed.
Organic compounds generate so called mass spectra. To identify unknown compounds the mass spectra will be compared with the NIST library in a current issue. This comprehensive library is the world’s most widely used mass spectral reference library with more than 240.000 entries.
A typical relative measurement uncertainty is ±10%.
High performance liquid Chromatography with UV Detector HPLC-UV
Ph. Eur. 10, 2.2.29
HPLC is a chromatographic method in which larger molecules in solution can be separated. The high separating capacity of the chromatographic system is used to determine single compounds in complex mixtures. The high linearity provided by the UV detector for UV active components makes it suitable for quantitative work.
A typical relative measurement uncertainty is ±10%.
High Performance Liquid Chromatography with Light Scattering Detector HPLC-ELSD
Ph. Eur. 10, 2.2.29
HPLC is a standard method for the determination of higher molecular weight compounds. In order to determine single compounds in complex mixtures qualitatively and quantitatively, the enormous separation performance of the liquid chromatographic system is used. The ELSD detector provides a sensitive and linear detection system for a large number of compounds that cannot be detected with other detector types (e.g. UV detector).
A typical relative measurement uncertainty is ±10%
Ultra Performance Liquid Chromatography with High-Resolution Mass Spectrometry UPLC-HR-MS
UPLC-HR-MS is a combination of HPLC and high resolution mass measurements. The use of special columns guarantees highest separation performance. The system is equipped with a Time-of-Flight Mass Spectrometer (TOF-MS) which provides a powerful combination of high resolution mass measurement with high sensitivity. It allows target quantitative analyses and structural elucidation and semi quantification for a wide range of analytes at low concentrations with appropriate standards.
Particulate residues from production or from transport simulations can be quantified and identified by us.
Light optical particle analysis (JOMESA)
Particles are measured and counted on filters by a digital camera in a fully-automated optical microscope. Polarized light is used to discriminate between metallic and non-metallic particles.
A typical relative measurement uncertainty is ±10%.
Scanning Electron Microscopy with Energy Dispersive X-Ray according to DIN ISO 22309:2015-11 SEM-EDS
[accredited method: PL-19422-01]
Microbeam analysis – Quantitative analysis using energy-dispersive spectrometry (EDS) for elements with an atomic number of 11 (Na) or above. Good results will be obtained for mass fractions down to 1%. SEM-EDS is the standard method for surface and particle analysis. Single particles can be inspected and identified on the basis of the emitted X-Ray spectra.
A typical relative measurement uncertainty for quantitative analyses is ±10%.
FT-IR-Microscopy
Ph. Eur. 10, 2.2.24 – Infrared spectroscopy [accredited method: PL-19422-01]
The best known and most widely used method for the analysis of organic compounds. After excitation with an IR source, each functional group in a molecule absorbs energy at distinguished frequencies. The spectra obtained are additive, from summation of individual components. Therefore, single components under 1% of the total cannot be detected with certainty.
The focal area of the IR Microscope covers 2,500µm² (0.0025mm²). Determining the limit of detection and limit of quantification is difficult, as analytes rarely cover surfaces in a homogenous manner. Usually, they exist in form of locally accumulated residues. Such accumulated residues can easily be identified at areas of approx. 100µm² or larger. Conversely, smaller areas are more difficult to analyze. The order of magnitude for easily detectable amounts is about 0.1µg/mm².
A typical relative measurement uncertainty is <1%.
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