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OFI Technologie & Innovation GmbH
About OFI Technologie & Innovation GmbH
The research and testing institute 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 laboratory. 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, including:
Quality Control and Development: Drug Release and Raw Material Testing, Method Development and Validation, Stability assessment studies
Pharmaceutical Packaging: Material Release Testing, CCI-testing, Extractables & Leachables
Medical Devices: Biocompatibility testing
Investigations: Expert Center Particles, Impurities, Nitrosamines
Products from OFI Technologie & Innovation GmbH (5)
Container closure integrity testing (CCIT) ensures adequate pharmaceutical packaging for your product. As an independent partner, OFI offers the optimal method of analysis for your packaging system.
Non-destructive testing of glass vials is performed by laser headspace analysis for oxygen ...
Pharmaceutical packaging serves an important protective function for your medicines and as such is a crucial part of your product.
OFI performs all necessary tests for you to ensure its quality, from compendial testing, to CCI testing, and extractables & leachables testing. We offer in-...
One focus of OFI is the evaluation of medical device biocompatibility. In accordance with the ISO 10993, a risk-based approach is used to obtain meaningful results and address product-specific requirements.
Our testing expertise includes in vitro testing for cytotoxicity according to ISO...
The quantification and trace analysis of a substantial number of elements is required for compendial assays and impurity tests as well as extractables & leachables testing.
OFI performs compendial testing for e.g. heavy metals in polymers under GMP, screening for elemental impurities a...
Our expertise is in assessing your product for impurities.
Nitrosamines are a harmful class of impurities which can form from secondary amines and nitrite under acidic conditions. We test raw materials for nitrite and support you in providing a safe and nitrosamine-free product through analy...
OFI Technologie & Innovation GmbH Resources (1)
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