Expert Guidance and Testing for MedTech Success
Since 1994, the GBA Group has been supporting manufacturers in the development, approval and production of safe medical devices. At GBA Group, we are committed to advancing the MedTech industry through comprehensive solutions, expert advice and precise testing. We combine consulting and laboratory testing in a unique way, supported by our experts throughout the entire life cycle of medical devices. Our specialist departments work hand in hand to provide medical device manufacturers with unparalleled support throughout the product lifecycle: from concept and development to approval and production monitoring.
Chemical characterization of extractables and leachables
Extractables and leachables are substances that are differentiated according to organic or inorganic residues. In the case of organic residues, the substances are further differentiated according to their volatility - from highly volatile to semi-volatile or non-volatile.
The substances released by the extraction process are examined using specific analytical methods, which make it possible to cover a broad spectrum of substance classes.
According to EN ISO 10993-18, the following analysis methods are recommended in particular:
Gas Chromatography - Mass Spectrometry GC-MS - Head-Space-Gas Chromatography - Mass Spectrometry HS-GC-MS - Liquid Chromatography - Mass Spectrometry LC-MS - Ion Chromatography - IC Inductively Coupled Plasma - Mass Spectrometry ICP-MS - Fourier Transform Infrared Spectrometry FTIR - Total Organic Carbon TOC - Gravimetry
LC-MS Technology at a Glance
Technical
• Non-targeted screening of non-volatile organic substances according to ISO 10993-18 for the semi-quantification and identification of leachables & extractables of your medical device
• Positive and negative ionization modes with 6 external standards
• High-resolution mass determination by Quadrupole/ Time-of-Flight technology
• Conformity with requirements of FDA Guidance to ISO 10993, for example by using internal standards and 8 points calibration curves of external standards
• Compound identification by Agilent and in-house-built PCDL (Personal Compound Database and Library)
• in silico fragmentation software to minimize unknown hits in identification
Your Benefits
• Accredited according to ISO 17025
• State-of-the-art analytics
• Evaluation of data by analytical chemistry experts
• More than 25 years of experience in testing of medical devices
• Well-structured and comprehensive analysis reports
• Inclusion and compliance of FDA Guidance to ISO 10993
• Direct and fast contact to experts
• Turnaround time 6 to 8 weeks after sample entry
• Well-founded and quick answers to questions of authorities