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Identification of impurities

Identification of impurities

Particle analysis

Particulate contamination of drugs and medical devices by organic and inorganic particles can lead to significant health risks for patients. Using highly sensitive analytical methods, OFI identifies the causes, whether in incoming goods inspection, in production or in the end product – and thus supports you in eliminating the impurities.

Detect, identify and eliminate contaminants

We use sophisticated analytical techniques to detect, quantify and identify particulate contaminants. This also includes the testing of such low volumes down to 0.5ml, which are typical e.g. for expensive injectables of biopharmaceutical products.

Whether drugs are in development, in the process of approval or already on the market: As an independent partner with GMP certification, OFI offers you internationally recognized services.

  • Tests according to USP , as well as
  • Tests according to EP 2.9.19 and JP 6.07
  • Qualitative and quantitative analyses of “Visible Particles
  • Quantitative analyses of “Subvisible Particles” from 2 μm
  • Verifications of analyses with particle counters
  • Characterization of particles using FTIR and SEM/EDX: rapid elucidation of the organic and inorganic material base and semiquantitative elemental composition.
  • EN 45502/ISO14708 – Active implantable medical devices
  • EN 45502/ISO14708 -1: General requirements for safety, markings and information to be provided by the manufacturer
  • EN 45502/ISO14708 -1: -2-x: Special requirements for product classes
  • Tests according to USP , as well as
  • Tests according to EP 2.9.19 and JP 6.07

Head of Pharma, Medical Devices & Hygiene

Dr. Michael Pyerin
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