Testing pharmaceutical and medical devices

OFI has developed numerous innovative test methods that have become well-established procedures. They include chemical, mechanical and physical tests on the one hand, and microbiological and sensory analyses on the other. As a flexible, privately owned testing and research institute, OFI provides a wide range of services for the pharmaceutical and medical devices sectors, at the pre-clinical stage, in the context of batch release, as well as extractables and leachables.

Quality control of pharmaceuticals

We provide more than just the standard methods for testing packaging: OFI's experts also develop new packaging systems for pharmaceutical products. With regard to pharmaceutical testing, OFI has obtained GMP certification in accordance with Section 63 of the Austrian Pharmaceuticals Act, for quality control of pharmaceuticals for use in humans and animals, as well as for test preparations.

What we offer

  • HPLC, HPLC-MS/MSn, TD/HS-GC-FID/MS, IC: identification and quantification of extractable ingredients, degradation and reaction products
  • UV-VIS spectroscopy
  • FTIR spectroscopy and FTIR microscopy for material characterisation and material identification
  • SEM/EDX: surface topography, direct characterisation of deposits, elemental spectra
  • CHN analysis
  • TOC
  • RFA, AAS, ICP-MS/OES: metals in liquids or solids
  • Optical microscopy
  • Wet chemistry methods: extraction, gravimetry, titration, residues, various limit tests
  • Climate-controlled storage: artificial ageing, material stability
  • Subvisible particle count in injection substances, in accordance with EP, USP and JP
  • Thermal analysis: comparative material characterisation (crystallinity, filler content, volatile content, oxidation stability)
  • Rheology: flow behaviour, melt viscosity, molar mass and molar mass distribution
  • Mechanical tests: tensile strength, compressive strength, flexural strength, hardness, leakage, adhesive strength, delamination and tear strength, puncture impact resistance
  • Biological tests: cell culture assays (cytotoxicity), classical microbiology (bacterial count, resistance), PCR (identification, quantification of micro-organism), in-vitro bioassays (e.g. for hormonal activity), material resistance