USP Comprehensive Testing Services
Trust Gateway Analytical to guide your biopharmaceutical products towards meeting and exceeding safety standards.
Gateway Analytical prides itself on providing comprehensive testing services aligned with the United States Pharmacopeia (USP) chapters <661>, <661.1>, <661.2>, and <665>. These guidelines are crucial for ensuring the safety and suitability of plastic systems, components and materials used in the manufacturing process of pharmaceutical drug substances (DS) and drug products (DP). Adhering to ISO 17025, Gateway Analytical ensures robust documentation, method verification, and validation, ready to meet varied pharmacopeial standards globally.
United States Pharmacopeia <661> (USP <661>)
United States Pharmacopeia <661> (USP 661) is a general chapter in the United States Pharmacopeia-National Formulary (USP-NF) document that provides guidelines for evaluating plastic packaging systems for pharmaceutical use. The chapter outlines the testing requirements for plastic containers, closures, and packaging materials to ensure they are suitable for pharmaceutical products. The tests described in USP <661> include physicochemical properties, extractables and leachables testing, and biological reactivity testing. Compliance with USP 661 is required by the U.S. Food and Drug Administration (FDA) for all plastic packaging systems used in the pharmaceutical industry.
United States Pharmacopeia <661.1> (USP <661.1>)
United States Pharmacopeia <661.1> is a chapter that provides test methods for determining the suitability of plastic materials of construction used in packaging systems for drug products. Individual plastic construction materials are considered well-characterized if they meet the requirements in this chapter or are used in a packaging system that meets the requirements in Plastic Packaging Systems for Pharmaceutical Use <661.2>. The testing and qualification of plastic packaging systems and components for pharmaceutical use are covered in <661.2>. This chapter contains tests, methods, and acceptance criteria for the following materials:
cyclic olefins, polyamide 6, polycarbonate, polyethylene, polyethylene terephthalate, polyethylene terephthalate G, poly(ethylene-vinyl acetate), polypropylene, polyvinyl chloride, and polyvinyl chloride, plasticized.
Our expertise covers a wide range of tests, from extractables and leachables to biocompatibility and physical properties assessment, ensuring your products not only meet FDA requirements but also uphold the highest standards of patient safety and product integrity.
United States Pharmacopeia <661.2> (USP <661.2>)
The United States Pharmacopeia (USP) 661.2 is a standard that applies specifically to plastic packaging systems used for packaging pharmaceutical drug products. It provides guidelines for the testing of plastic packaging systems to ensure they are suitable for pharmaceutical use. USP 661.2 testing largely mirrors the physicochemical and biocompatibility aspects of USP 661.1 for low risk and higher risk health-related product packaging, with one major difference. USP 661.2 includes a chemical suitability/safety assessment using comprehensive extractable and leachable testing.
United States Pharmacopeia <665> (USP <665>)
The United States Pharmacopeia (USP) <665> is a general chapter that provides guidelines for evaluating plastic components and systems used to manufacture pharmaceutical drug products and biopharmaceutical drug substances and products. This includes both single-use systems and multi-use systems. The chapter outlines the testing requirements for these plastic components and systems to ensure they are suitable for their intended use and do not pose a risk to human health
