New USP Requirements on Plastic Packaging Systems

Recommendation

7/8 May 2024

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An interesting article from the USP on the future requirements for plastic packaging systems has been published in the Pharmacopoeial Forum 39(6).

In this article, the USP's experts group provides an overview of the already existing and also the planned General Chapters on pharmaceutical plastic packaging systems. Together both chapters aim to describe a general and chemistry-based approach for the quality and safety of packaging systems and their starting materials for the construction of these packaging systems.

Among the key topics which are discussed, you can find:

• a. The selection of suitable, safe plastic materials of construction
• b. The importance of characterizing both the materials of construction and the packaging system
• c. Extractables and leachables

Interactions between the product and the packaging system which may influence the quality of the product are of significance. Such interactions can be additive, reductive or transformative. In case of additive interactions, a constituent of the packaging system is added to the product; if reductive, a product constituent is reduced - for example due to its uptake into the packaging system. Transformative interactions may lead to a loss of stability for example because of physicochemical interactions.

The two new chapters:

• <661.1> - Plastic Packaging Systems and their Materials of Construction, and
• <661.2> - Plastic Packaging Systems for Pharmaceutical Use

should also be clearly delimited against elastomeric closures, containers made of glass and containers made of metal which have their own General Chapters.
 
 You will find more information on the USP Pharmacopeial Forum (PF) website.

Source: USP