USP REVISES PLASTIC MATERIALS AND PACKAGING SYSTEMS CHAPTERS

In May 2016 the U.S. Pharmacopeial Convention (USP) revised and renamed its general Container-Plastics [661] test chapter and created two new general chapters. These provide test methods and specifications for Plastic Materials of Construction [661.1] and Plastic Packaging Systems for Pharmaceutical Use [661.2].

The USP understands the importance of properly identified materials when it comes to the production of packaging systems. The new chapters will help to determine whether a material is deemed suitable for its intended use by establishing its identity, biocompatibility, physicochemical properties, additives and extractable metals. 

Chapter [661.1] deals solely with individual plastic materials and should not be applied to packaging systems. Currently the following materials are ­covered: polyethylene, polyolefins, polypropylene, polyethylene tere­phthalate, polyethylene terephthalate G (PETG) and polyvinyl chloride. 

The plastic packaging systems in chapter [661.2] refer to the sum of all packaging components used to house the pharmaceutical product. This includes primary components in direct contact with the pharmaceutical and secondary components such as bags, bottles, cartridges, inhalers, pre-­fillable syringes, vials and bottles. Packaging systems should be composed of properly identified materials that are safe to use with the pharmaceutical product, provide adequate protection and do not release substances that could adversely affect efficacy or user safety.

The testing methods depend on the dosage form as well as the construction and composition of the packaging system. [661.2] deals exclusively with plastic packaging systems, but due to the variety of materials in use (lacquers, adhesives, aluminum), the chapter does not exclude the use, if justified, of alternative testing methods.

The holder of the drug product application bears primary responsibility and accountability for ensuring that the requirements of the chapters are met. The means by which the holder obtains the information to meet the requirements are at the discretion of the holder.

For more information see the USP’s frequently asked questions.