Quality systems

For many years, standardized and internally as well as externally validated processes and procedures at Fraunhofer IGB have been safeguarding a reliable and consistent quality of our services and products.

Quality management

An efficient quality management system ensures that selected test procedures (chemical analytics) are accredited according to the international DIN EN ISO/IEC 17025 standard.

Quality assurance

Our quality assurance system ensures that the statutory guidelines of Good Laboratory Practice (GLP) are complied with.

The accreditation of reference laboratories and test procedures of our analytics according to DIN EN ISO/IEC 17025:2018 guarantees that our proprietary, in-house test methods and procedures are validated and that the quality of our tests is assured even where no standardized methods are available.

Accredited analytical methods and test procedures:

• High-performance liquid chromatography (HPLC)
• Ion chromatography (IC)
• Gas chromatography (GC)
• Atomic emission spectrometry (ICP-OES)

Several non-clinical tests are running at our category 9 GLP unit (“Cell-based test systems for the determination of biological parameters”) to support R&D projects that investigate biological parameters of samples using cell-based assays.

Examples are the

• Testing of bioactivity, cytotoxicity and immunogenicity of compounds using immune receptor-based assays
• Screening of TLR agonists/antagonists
• Testing of antimicrobial properties of substances or surfaces
• Detection of pyrogens and microbial residues (pathogen-associated microbial patterns, PAMPs)
• Detection of viruses