Expert Center Particles

Particulate impurities of pharmaceutical products and medical devices caused by organic or inorganic particles can produce considerable health risks to patients. By means of highly sensitive analysis methods, OFI identifies the cause of impurities, from incoming goods inspection to the manufacturing stage and the final product, thus helping you to eliminate impurities.

 

Recording, identifying and eliminating impurities

We use sophisticated analytical methods to detect, quantify and identify particulate impurities. This also includes the testing of such low volumes up to 0.5ml as are typical for expensive injectables of biopharmaceutical products.

 

Our services (QM system: GMP)

Characterization and quantification of particles for pharmaceutical products

  • Tests according to USP 787, 788 as well as 789
  • Tests according to EP 2.9.19 and JP 6.07
  • Qualitative and quantitative analysis of visible particles
  • Quantitative analyses of subvisible particles beginning from 2 μm
  • Verification of analyses with particle counters
  • Characterization of particles using FTIR and REM/EDX: Rapid clarification of organic and inorganic material basis and semi-quantitative elemental composition

 

Characterization and quantification of particles for medical devices

  • EN 45502/ISO14708 - Active implantable medical devices
  • EN 45502/ISO14708 -1: General requirements for safety, labels and information to be provided by the manufacturer
  • EN 45502/ISO14708 -1: -2-x: Specific requirements for product classes
  • Tests according to USP 787, 788 as well as 789
  • Tests according to EP 2.9.19 and JP 6.07