USP develops new General Chapter on Metal Packaging Components

The USP Expert Committee "General Chapters—Packaging and Storage" recently announced to develop a new General Chapter <662>. The proposed title is "Metal Packaging Components and their Materials of Construction".

The Announcement was posted on February 26, 2016 with an input deadline of March 29, 2016.

The suggested audience are suppliers of metal materials and components used for packaging systems (primary packaging components) and drug product manufacturer using metal primary containers. Publication of the proposal in Pharmacopoeial Forum is expected for PF 44 (2018).

Aluminum is one of the oldest packaging materials used for food, for example to wrap chocolate in it. Metal packaging systems were first used to package pharmaceutical products in the early 1900s due to its lightness and its impermeability to light and moisture. Common metal packaging components include aluminum and its alloys, stainless steel, tin-free steel, and tinplate. Within the pharmaceutical industry, primary metal packaging systems can include aerosols, blister packs, canisters, collapsible tubes, drums and gas cylinders, and secondary packaging systems such as overwraps and seals. Currently there are no compendial standards for metal packaging systems. Thus, to help ensure the safety and suitability of metal packaging system for pharmaceutical products, the USP will develop a new chapter that will provide test methods and standards for metal materials of construction and packaging system.

The scope and applications are metal materials and components that make up a primary packaging system.  The chapter should be used in helping determine the safety and suitability of metal packaging system for pharmaceutical products.

Furthermore, to initiate the work of the USP Expert Committee, a teleconference will be held by USP to discuss the scope and goals of the General Chapter with interested parties. The intent is to have a dialogue regarding practices that are currently used by suppliers and product manufacturers to ensure safety, suitability and compatibility. The input received during this call will provide a foundation for the first draft of this new General Chapter.

For more information please visit the USP website. Additionally a stimuli article (Metal Packaging Systems and Their Materials of Construction for Pharmaceutical Products) to the proposed general chapter has been published in PF 39(4) (July-August 2013). Following your registration on the USP Pharmacopeial Forum  website you can get to the complete article.

Go back


Stay informed with the GMP Newsletters from ECA

GMP Newsletter

The ECA offers various free of charge GMP newsletters for which you can subscribe to according to your needs.

To subscribe, please click here.