USP <661.1> Plastic Materials of Construction

<USP 661.1> is a standard that specifies the requirements for plastic materials used in the construction of pharmaceutical packaging systems. This standard aims to ensure that the materials used are well-characterized and suitable for their intended use. The characterization includes the identification of the material, its biological reactivity, general physicochemical properties, and composition, including any additives that may be present. The standard also addresses the need for testing extractable elements and TOC (Total Organic Carbon), listed in the physicochemical tests section, which can be relevant to the selection of a packaging system's materials of construction.

The test methods specified in USP <661.1> are important because they provide standardized procedures for the precise and reliable characterization of plastic materials. These methods ensure high sensitivity and specificity in detecting relevant properties and elements, supporting effective quality control and regulatory compliance in the pharmaceutical industry. E. g., for the parameter TOC USP monograph 〈643〉 is referred to for the measurement, calibration and system suitability tests. However, for tests carried out under <USP 661.1> the TOC method used must have a limit of detection of 0.2 mg/L (ppm) and should have a demonstrated linear dynamic range from 0.2 to 20 mg/L. The acceptance criteria for the TOC test solution produced according to this standard is a difference between sample and blank TOC concentrations on NMT 5 mg/L. If this specification is exceeded for TOC the material can still be used if the responsible organic chemicals by identity and concentration can be characterized and probable risks posed by them are within acceptable limits.

By providing detailed guidelines for material characterization, <USP 661.1> helps manufacturers select appropriate materials for packaging systems, ensuring the safety and efficacy of pharmaceutical products.

Analytik Jena offers customized solutions and expertise for the pharmaceutical industry. With the multi N/C x300 series, we offer a range of high-quality and reliable TOC analyzers following either the high-temperature catalytic oxidation or the UV/wet-chemical sample digestion principle combined with sensitive and selective CO₂ quantification by NDIR (non-dispersive infrared) detection principle. The devices not only meet the requirements of USP <643>, but they also fulfill the requirements of EP 2.2.44, JP 2.59 and KP and come along with full FDA 21 CFR Part 11 and data integrity compliance.

Our solutions for USP <661.1>

Sources

• <USP 661.1> - Plastic Materials of Construction