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Jul 19 , 2022


The purpose of this chapter is to provide standards for plastic materials and components used to package medical articles (pharmaceuticals, biologics, dietary supplements, and devices). Definitions that apply to this chapter are provided in Packaging and Storage Requirements 〈659〉. Standards and tests for the functional properties of containers and their components are provided in Containers—Performance Testing 〈671〉.

In addition to the standards provided herein, the ingredients added to the polymers, and those used in the fabrication of the containers, must conform to the requirements in the applicable sections of 21 Code of Federal Regulations (CFR), Indirect Food Additives, or have been evaluated by the FDA and determined to be acceptable substances for the listed use.

Plastic articles are identified and characterized by infrared (IR) spectroscopy and differential scanning calorimetry (DSC). Standards are provided in this chapter for the identification and characterization of the different types of plastic, and the test procedures are provided at the end of the chapter. The degree of testing is based on whether or not the container has direct contact with the drug product, and the risk is based on the route of administration.

Plastics are composed of a mixture of homologous polymers, having a range of molecular weights. Plastics may contain other substances such as residues from the polymerization process, plasticizers, stabilizers, antioxidants, pigments, and lubricants. These materials meet the requirements for food contact as provided in 21 CFR. Factors such as plastic composition, processing and cleaning procedures, surface treatment, contacting media, inks, adhesives, absorption and permeability of preservatives, and conditions of storage may also affect the suitability of a plastic for a specific use. Extraction tests are designed to characterize the extracted components and identify possible migrants. The degree or extent of testing for extractables of the component is dependent on the intended use and the degree of risk to adversely impact the efficacy of the compendial article (drug, biologic, dietary supplement, or device). Resin-specific extraction tests are provided in this chapter for polyethylene, polypropylene, polyethylene terephthalate, and polyethylene terephthalate G. Test all other plastics as directed for Physicochemical Tests. Conduct the Buffering Capacity test only when the containers are intended to hold a liquid product.

Plastic components used for products of high risk, such as those intended for inhalation, parenteral preparation, and ophthalmics, are tested using Biological Tests.

Plastic containers intended for packaging products prepared for parenteral use meet the requirements for Biological Tests and Physicochemical Tests. Standards are also provided for polyethylene containers used to package dry oral dosage forms that are not meant for constitution into solution.

Source from USP and Please refer to USP for details:

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