OFI Technologie & Innovation GmbH

About OFI Technologie & Innovation GmbH

OFI provides assistance for the targeted, efficient development of your new products. Your concerns will always be given priority.Why? Because, rather than developing our own products, we act as a 100% privately owned, independent and self funded research and testing institute.Whether medicines are in the development or authorisation stage, or already on the market, we offer you international services based on GMP, EMA and US guidelines and testing of primary, secondary and tertiary packaging materials.

  • AT
  • 2016
    On CPhI since
  • 2
Contract Service
Contact info

Products from OFI Technologie & Innovation GmbH

  • Extractables & Leachables (E&L) studies

    Product Extractables & Leachables (E&L) studies

    Extractables and Leachables (E&L) studies are performed to assess the safety of pharmaceutical packaging and medical devices.

    As a testing and research institute, OFI has detailed experience in the field of polymers and the performance of (E&L) studies. We offer you the highest quality and efficiency by using advanced trace analysis to detect, quantify and identify contaminants.
  • Expert Center Particles

    Product Expert Center Particles

    Particulate impurities of medicines caused by organic or inorganic particles can pose considerable health risks to patients.

    In addition to compendial particulate matters testing, OFI runs an expert center to identify the cause of impurities. We use highly sophisticated analytical methods, such as FTIR, SEM/EDX and particle counters, to detect, identify and quantify particulate impurities.
  • Drug Release and Raw Material Testing

    Product Drug Release and Raw Material Testing

    In order to guarantee patient safety for new drugs and medical products, expert driven and reliable analysis under GMP is necessary.

    OFI accompanies and evaluates your new developments, and also supports you in questions concerning products on the market. Relying on an interdisciplinary team of experts and highly developed analytical procedures, OFI offers batch release testing for medicinal products and raw materials. Whether you need compendial testing, analytical method development,  validation, or assistance in case of damage like unidentified side products or particles, OFI can always provide you with the best consulting in order to get immediately ready for market and authorities.
  • Container Closure Integrity (CCI)

    Product Container Closure Integrity (CCI)

    A container and closure integrity test (CCIT) must be carried out to ensure the tightness of the packaging. As an independent partner, OFI uses highly developed analytical methods, to provide you data of your packaging for leaks and its barrier function. This includes non-destructive testing, such as testing of your product in glass containers by Laser Headspace analysis for oxygen ingress. Alternatives to assess disposable and reusable pharmaceutical containers are the dye immersion testor the bacteria immersion test. This can be accompanied by testing for permeability of e.g. water vapour, or testing for strength of sealed seams.
  • Method Development and Validation

    Product Method Development and Validation

    In order to guarantee the reliability of analytical results, methods must be properly developed and fully validated.

    OFI accompanies and evaluates your new developments and supports you in questions concerning products on the market. OFI is specialized in method development for analytical questions of your specific product or raw material. In order to guarantee the reliability of analytical results, OFI carries out full method validations to the highest quality standards.
  • Expert Center for hyaluronic acid gels

    Product Expert Center for hyaluronic acid gels

    In order to bring your hyaluronic acid gel to market with the highest level of safety, several tests are usually requested by the authorities.

    OFI assists you with test under ISO17025, including assay, degradation, gel-to-fluid-ratio, cross-linking level or viscosity, as well as testing for assay and degradation of active pharmaceutical ingredients.
  • Pharmaceutical packaging

    Product Pharmaceutical packaging

    Various tests are necessary to ensure the safety of pharmaceutical packaging and medical devices.

    OFI´s interdisciplinary team of experts and highly developed analytical procedures supports you in conformity tests according to Pharm. Eur. and USP, Extractables and Leachables studies and container closure integrity tests
  • Proteinanalytics

    Product Proteinanalytics

    In addition to client-funded research & analysis, OFI offers protein analysis under GMP with state-of-the-art methods and equipment: Our interdisciplinary experts accompany and evaluate your new developments with highly developed analytical methods, such as Protein identification, Protein quantification, Peptide Mapping, Immunological methods (ELISA).

    Our services in protein analysis have a wide range from Pharmaceuticals to Allergens and Medical devices.
  • Testing for biocompatibility

    Product Testing for biocompatibility

    The use of biocompatible materials in medical devices guarantees a high level of patient safety.

    OFI carries out biocompatibility tests as well as skin compatibility tests and checks whether the medical devices also meet all other product-specific additional requirements.

    We offer you analysis for your product approvals under ISO17025 as well as contract research and research within the framework of funded national and international projects. In the test strategy, care is taken to ensure that animal testing is as unnecessary as possible. In addition to chemical characterization, validated in-vitro and in-chemico methods are used.
  • Stability assessment studies

    Product Stability assessment studies

    Determining the shelf life of APIs and pharmaceuticals is an important part of pharmaceutical development and production.

    OFI carries out stability testing of your products according to ICH under various climatic zones, as well as photo stability testing. If you are starting from the beginning, we also provide stress tests for you in order to identify possible degradation products.