Method Development and Validation

Method Development and Validation
Product Description

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.

OFI Technologie & Innovation GmbH

  • AT
  • 2016
    On CPhI since
  • 2
    Certificates
Contract Service
Specifications

OFI Technologie & Innovation GmbH

  • AT
  • 2016
    On CPhI since
  • 2
    Certificates
Contract Service

More Products from OFI Technologie & Innovation GmbH

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    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.
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    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.
  • 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.
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    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.
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    Product Testing for biocompatibility

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  • 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.

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