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The laboratory for Polymer- und Migrationsanalytik provides expertise in analytical method development with a focus on Extractables & Leachables and polymer analysis (FCM, recycling materials, additive profiles). As a non-GMP laboratory, we enable extensive testing in an early or pre-project phase, thereby following regulatory standards for laboratory management.
In general, we deal with the design of analytical methods for quality assurance of production processes by identifying, characterizing and quantifying impurities and by-products in pharma, food, cosmetics, polymer and construction materials. We also support companies regarding general process evaluation and in experimental outlines prior to GMP phase. Our team of experienced scientists is available for time-critical issues as an additional external partner and has access to modern infrastructure.
The related infrastructure consists of two laboratories and a supply room with an area of around 120 m2 plus associated equipment. The laboratory for Polymer- Migrationsanalytik has access to several GC/MS and LC/MS systems (Agilent 5975 Single Quadrupol MS, Agilent 7890 GC, Agilent 7890 GC-FID, both with headspace equipment and SPME, Agilent 6460 Triple Quadrupol MS, Agilent UHPLC 1260, Agilent 1260 Infinity LC, Agilent 1290 Infinity LC with Agilent 6450 QTOF mass spectrometer, Thermo LCQ fleet ion trap MS, Thermo UHPLC Accela 1000) as well as devices for sample preparation (SPE equipment, SpeedVac, glove box, safety weighing cabin).
We offer support regarding analytical method development and analysis in the field of GC-MS/MS and LC-MS/MS.
Our services include the experimental outline, the selection of suitable methods e.g. according to regulatory requirements, the analysis of process intermediates/sample batches and stability studies, data processing and statistical analysis, the validation of analytical processes and data dissemination as well as interpretation.
In the R&D environment, we cooperate with partners from university sector by developing and constantly expanding an extensive portfolio of analytes for the qualitative and quantitative determination of Extractables & Leachables, NIAS, polymer additives and their specific degradation products as well as volatile organic degradation products.
Different fatty acid screenings and hormone determinations are available for biological applications e.g. in saliva or blood.
Methods & Expertise for Research Infrastructure
Based on our expertise in dealing with volatile substances in different matrices, we carry out qualitative and quantitative analyses taking into account specific process simulations. Besides detection of target analytes e.g. nitrosamines or residual solvents, product-specific screenings are conducted. We use SPME methodology in detection of degradation products from polymer additives that is of special interest for durability of materials and recycling products.
The GC-MS/MS system is applied for the detection of target compounds with particularly challenging detection limits. Based on previous knowledge e.g. Extractable studies, sensitive methods for target analytes e.g. Leachables are established and validated in-house. Existing methods include plasticizers, flame retardants, nitrosamines, PCBPs and an Extractables/Leachables database.