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Area of competence

Pharma, Medical Devices & Hygiene

Assessment of medical and pharmaceutical products
The evaluation of medical or pharmaceutical products is one of our core competencies at OFI. Our range of services includes testing for pharmaceuticals, raw materials and packaging, approval testing of medical devices and the development of innovative hygiene concepts in the field of surface hygiene and air hygiene.
Beurteilung von medizinischen und pharmazeutischen Produkten

Pharmaceuticals: approval and development

Do you produce pharmaceuticals or pharmaceutical products or are you currently planning new projects? In drug development and release analytics, OFI specializes in addressing chemical and physical issues. In addition to stability studies, we perform degradation studies as well as particle checks. Method development and validation as well as the elucidation of unknown substances complete our range of services. Our experts at the OFI support you in the development or approval of classical chemical active ingredients and biopharmaceuticals, but also in questions concerning products on the market.


Our services (QM system: GMP)

  • Drug development and release analytics
  • Stability and degradation assessment studies
  • Analytics of proteins and biopharmaceuticals
  • Method development and validation for analytical problems
  • Expert Center: Particle testing
  • Clarification of unknown substances and particles

Packaging for medicines

Do you want to submit a drug for approval together with a pharmaceutical package? To ensure that there is no negative impact on your drug product from the packaging, compliance testing, extractables and leachables (E&L) studies, and CCI testing are performed at OFI. To protect your products, we offer both physical and chemical tests on packaging and investigate their interaction with the drug.

Our services (QM system: GMP)

  • Conformity tests according to Pharm. Eur. and USP
  • Extractables and Leachables Studies
  • Container Closure Integrity (CCI)

Testing, development and approval of medical devices

Whether in the context of development, during the approval of medical devices or for products already on the market. We are happy to test your medical devices for biocompatibility using non-animal in vitro methods as well as chemical analysis methods. Our experts perform aging and stability studies as well as degradation and particle testing studies for many different materials such as plastics, metals but also degradable biopolymers.

Our services (QM system: ISO/IEC 17025)

  • Biocompatibility according to ISO 10993
  • Chemical characterization
  • Degradation studies
  • Stability and aging studies (shelf life)
  • Expert Center: Particle testing
  • Expert Center: Hyaluronic acid and gels

Assess compliance with hygienic requirements

Based on years of experience in the development of innovative hygiene concepts, we act as a competent partner for our customers. Whether we are testing the compatibility of disinfectants with the material, or the use of biocide-equipped antimicrobial materials, or assessing the elimination of airborne biogenic hazards. We convince with experience, competence and fast execution.

Our services (QM system: ISO/IEC 17025)

  • Air hygiene and filter tests
  • Surface hygiene

Research Development and Innovation: Pharmaceuticals, Medical Devices and Hygienic Requirements

With its interdisciplinary know-how, the OFI is at your side as an innovative and strong partner in research and development projects. An excerpt from our projects:

All services from Pharma, Medical Devices & Hygiene at a glance

Head of Pharma, Medical Devices & Hygiene

Dr. Michael Pyerin

OFI Expert for Pharma

Dr. Friedrich Bialas

OFI Expert for Medical Devices & Hygiene

DI Gabriele Ettenberger-Bornberg, BA

OFI Expert for Medical Devices

DI Dr. Elisabeth Mertl
A selection of projects from this area


Forschungsprojekt AeroMobil
Development of an innovative modular mobile test facility for modeling the microbiological efficiency of air purification under real conditions ...
Establish the scientific basis for safety evaluation of menstrual products. ...
Autonomer Hygieneroboter zur Desinfektion von Oberflächen in Gesundheitseinrichtungen
Development of autonomous, intelligent hygiene robots that use UV/LED to reduce infection germs. ...
Sujetbild Forschungsprojekt E-Steril
Investigation of an autonomous, self-regenerating air filter ...
Hanf als Werkstoff nutzen
Material properties of hemp: Optimization of the natural bactericidal, virucidal and fungicidal effect of hemp fibers. ...