Extractables and Leachables Studies
Extractables and leachables (E/L) studies are employed to identify and quantify impurities which could migrate from pharmaceutical container closure systems, process equipment and packaging to contaminate pharmaceutical and biopharmaceutical products. E/L studies are also employed to assess the potential of implantable medical devices to release impurities.
Using controlled extractables studies a profile of extractable components is obtained, in order to identify potential sources of leachables such as antioxidants, plasticizers, dyes and metal catalysts. With mixtures of plastic, polymer, rubber or glass materials, printed surfaces and coatings, pharmaceutical packaging, drug delivery systems and implantable medical devices can be extremely complex. To address this, E/L studies must be designed specifically for your product and the container materials so that the risks associated with leachable impurities can be assessed.
Quantum scientists conduct extractables and leachables studies in accordance with Good Manufacturing Practices (GMPs) ,PQRI recommendations, United States Pharmacopeia (USP) requirements (including USP chapters <661>, <661.1>, <661.2>, <1663>, <1664>, and <1664.1>), recommended FDA guidelines, and recommendations of the Extractables Work Group of the BioPhorum Operations Group (BPOG) . Since a single approach to E/L studies does not fit all needs, our approach is to gain a complete understanding of our customer’s objectives, the material being used, and the potential interactions likely to occur thorough the manufacturing process. Based upon these assessments our scientists will design a custom study to assess potential sources of risk and minimize the potential for regulatory delays.
Our analytical groups can determine both organic and inorganic contaminants through the application of a range of instrumentation including gas chromatography (GC), gas chromatography-mass spectrometry (GC-MS), liquid chromatography (HPLC), liquid chromatography-mass spectrometry (LC-MS), ion chromatography (IC), and inductively coupled plasma spectroscopy (ICP, ICP-MS), dependent on the analyte analysis.
Once a profile of extractable components is obtained, we can develop validated analytical methods for those leachables, compliant with regulatory requirements and GMPs for use in storage and stability programs. These can support a wide range of closure or drug delivery systems such as pre-filled syringes, large volume parenteral products, single use and disposable medical equipment, printed packaging and single use systems (SUS) bioprocessing equipment. Leachables associated with drug delivery systems, implantable medical devices and other devices such as e-cigarettes are also assessed.
Whatever your product requirements, Quantum can provide the analytical services to support all phases of product development.
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