Physicochemical Analyses of Materials and Surfaces

Dr. Xin Xiong
Group Leader Biofunctionalized Surfaces

+49 7121 51530-413

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Dr. Hanna Hartmann
Head of Biomedicine & Material Sciences
Group Leader Regenerative Biomaterials

+49 7121 51530-872

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We offer chemical-physical analyses according to regulatory and/or your customer-specific requirements that support you in the manufacture of safe and effective products.

Physicochemical characterization is a fundamental characterization required by the MDR and IVDR for the safety and efficacy evaluation of medical and IVD products.

Medical, pharmaceutical, and even cosmetic products are subject to strictly detailed chemistry, manufacturing, and controls (CMC) requirements that include the specific manufacturing process, product characteristics, and associated product testing that must be performed.

The NMI supports your manufacturing and quality control processes with a wide range of complementary physicochemical characterizations. Our in-depth understanding of applications, methods and industry knowledge will help you choose the right measurement procedures.

Our services

Consulting and evaluation

• Regulatory technical testing
• Test reports from customers
• Design of development and test plans

Experimental and analytical services

• Development of materials as well as (functional) coatings (e.g. antibacterial coatings, drug release coatings) and coating processes
• Performance of degradation tests
• Detection of degradation products (based on DIN EN ISO 10993-13 and -15)
• Simulated applications and stability tests
• Release kinetics of active ingredients and degradation products
• Particle analysis
• Identification and quantification of active ingredients according to USP (HPLC, UV/VIS)
• Mechanical properties (based on ISO 25539), rheology
• Analysis of layer structure and thickness (QCM, ellipsometry, profilometry)
• Polymer analysis (MALDI-TOF, SEC)

Our methods

Spectroscopic methods

• Raman spectroscopy
• UV/VIS spectroscopy
• Fluorescence spectroscopy
• FTIR

Optical methods

• Light microscopy
• Fluorescence microscopy

Mass spectrometric methods

• MALDI-TO
• ICP-MS

Coating thickness determination

• Ellipsometry
• QCM
• Profilometry

Chromatographic methods

• HPLC
• SEC

Thermal analyses

• DSC (Differential Scanning Calorimetry)
• Melting point determination

Rheological analyses

Surface properties

• AFM
• Contact angle
• Zeta potential

Our devices

• qCell T Advanced Quartz Crystal Microbalance (QCM) with damping and active temperature control (3T GmbH & Co.KG, Tuttlingen, Baden-Württemberg, Germany)
• Particle size, molecular weight and zeta potential meter Nano ZS (Malvern Instruments Ltd, UK)
• Direct access to confocal laser scanning microscopy, fluorescence microscopy, cryo FIB/SEM, analytical S/TEM (Group: Applied Materials Research and Electron Microscopy)
• HPLC
• SEC
• Ellipsometer
• Rheometer
• DSC
• MALDI
• Contact angle
• UV/VIS
• Fluorescence spectrometer
• Fluorescence microscope