Is Your Plastic Material Suitable for Pharmaceutical Use?
If you are considering registering plastic material with the FDA in a Drug Master File (DMF), evaluating the safety of that plastic is key. As of May 2016, a revision in the U.S. Pharmacopeia’s monograph for <661> changes the requirements for the testing of polymeric materials used for pharmaceutical packaging. The updated monograph has been divided into <661.1>, “Plastic Materials of Construction,” and <661.2> “Plastic Packaging Systems for Pharmaceutical Use.” In order that a plastic material be considered suitable for pharmaceutical use, it should be thoroughly characterized. While not all polymers are cited specifically in the monograph, those that are, polyethylene, polypropylene, polyolefin, poly (vinyl chloride), and polyethylene terephthalate, are most commonly used in the pharmaceutical industry for packaging systems. Plastic materials of construction not included in this list must be characterized with the same intent. The evaluation of a polymer material of construction according to USP <661.1> is extensive, and includes identification, physico-chemical testing, biological reactivity, additives analysis, and extractable metals.
Plastic Packaging Systems include any container, whether it is bag, bottle, syringe, or inhaler, which comes into direct or indirect contact with the drug product. Therefore, the packaging system also includes secondary components such as labels, closures, and printing. Evaluation of a plastic packaging system according to USP <661.2> includes biological reactivity, and physicochemical testing. A chemical safety assessment of the plastic packaging system should also be considered, and this could be accomplished through extractables and leachables testing. Please visit our USP 661 webpage for more information.
Impact Analytical is a contract testing laboratory supporting all phases of drug development and manufacturing. We offer method development, validation, stability, extractables & leachables, dissolution, problem solving, unknown identification, and release testing services. We have 30+ years of polymer and chemistry analysis experience. Our in house methods and databases allow us to quantitatively determine extractables in all CCS material types and identify unknowns. Impact Analytical is a GMP registered, GLP compliant (FDA, EPA), ISO 9001 certified, and DEA licensed. We follow PQRI best practices for E&L studies. Our customer-focused approach differentiates us in the industry and ensures you receive high quality results that are on-time and on-budget. Please contact us or visit our website www.impactanalytical.com to schedule a facility audit and discuss your next project.
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