Evaluation of medical and pharmaceutical products

The evaluation of medical and pharmaceutical products is one of our core competencies at OFI. Our range of services includes tests for pharmaceuticals, raw materials and packaging, approval tests for medical devices as well as the development of innovative hygiene concepts in the field of surface hygiene and air hygiene.

 

Pharmaceuticals: Approval and development

Do you produce drugs or pharmaceutical products or are you planning new projects? In drug development and release analysis, OFI is specialised in dealing with chemical and physical issues. In addition to stability studies, we also carry out degradation studies and particle analysis. Method development and validation as well as the clarification of unknown substances complete our range of services. Our OFI experts support you in the development or approval of classic chemical active ingredients and biopharmaceuticals, as well as in questions relating to products on the market.

 

Our services (QM system: GMP)

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

 

Packaging for pharmaceuticals

Do you want to submit a drug together with pharmaceutical packaging for approval? In order to ensure that the packaging does not adversely affect your drug, OFI conducts conformity tests, extractables and leachables (E&L) studies and CCI tests. 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 Ph.Eur. and USP
  • Extractables and Leachables Studies
  • Container Closure Integrity (CCI)

 

Testing, development and approval of medical devices

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

 

Our services (QM system: ISO/IEC 17025)

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

 

Assess compliance with hygienic requirements

Due to many years of experience in the development of innovative hygiene concepts, we act as a competent partner for our customers. No matter whether we check the compatibility of disinfectants with the material or the use of biocide-equipped antimicrobial materials or assess the elimination of biogenic hazardous substances in the air: 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 hygiene requirements

With its interdisciplinary know-how, OFI is your innovative and strong partner for research and development projects. An excerpt from our projects:

 

QUANTUM (2009-2013)
Development of screening methods for critical trace components of plastics.

 

XENO (2010-2014)
Development of bioanalytical methods for screening food contact materials for xenohormones.

 

Biorelation (2013-2017) and proTect (2016-2020)
Development of animal-free in-vitro and in-chemico methods as well as proteomic methods for the assessment of the biocompatibility of medical devices, hygiene articles, textiles and much more.

 

Ortho.flex.c (2016-2019) and MediTex (2018-2019)
Development of implants and textile elastic medical products.

 

BiKoPla (2013-2017) and E.Lyse (2017-2019)
Development of antimicrobial surfaces using biocides and physical mechanisms of action.

 

HygO (2013-2016) and SaferTex (2019-2020)
Development of sustainable hygiene concepts and technologies in health care facilities to assess the resistance of materials to disinfectants and the interaction of disinfectants with textiles.

 

Airclean (2014-2017) and Aeropore (2017-2021)
Development of a simulation system for testing filter media with the aim of reducing biological hazards in indoor areas.

 

Your Contact Persons

 

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Expert for medical devices & hygiene

Gabriele Ettenberger-Bornberg
t: +43 1 798 16 01 - 624
m: +43 664 516 2574
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