Revised USP Chapter <671> Containers - Performance Testing adopted

Recommendation

7/8 May 2024

Extractables & Leachables - Live Online Training
Challenges and Solutions for Packaging and Single Use Systems

With USP 41 - NF 36 the revised general chapter <671>  Containers - Performance Testing will become official on May 1, 2018.
The USP states, "it is the purpose of this chapter to provide standards for the functional properties of packaging systems used for solid oral dosage forms (SODFs) and liquid oral dosage forms (LODFs)".

As reported before in Draft USP Chapter <671> Containers - Performance Testing a revised version of general chapter <671> was published in Pharmacopeial Forum 43(1) [Jan.-Feb. 2017].

On the basis of comments received, the General Chapters—Packaging and Storage Expert Committee has made the following changes:

• Complete reorganization of the chapter to clearly delineate the sections on the scope of the classification systems,
• Consolidation of the classification tests for blisters and packs,
• Additionally, minor editorial changes have been made to update the chapter to current USP style.

The tests in this chapter may be applied to other dosage forms with the appropriate justification. The tests are provided to determine the moisture vapor transmission rate (water vapor permeation rate) for plastic packaging systems for manufacturers, packagers, and repackagers.

The classification system includes methods that allow pharmacists and institutional repackagers to select appropriate containers for repackaging of SODFs and LODFs. The classification system provided can also be used by the drug product manufacturer for testing packaging systems that have had the primary seal broached. Definitions that apply to this classification system are provided in the USP chapter Packaging and Storage Requirements <659>.

The previously proposed deletion of the Spectral Transmission section, which is contained in Containers—Glass <660> and is being added to Plastic Packaging Systems for Pharmaceutical Use <661.2> in PF 42(4) [July–Aug. 2016] has not been introduced. This may be postponed until the chapters <661.1> and <661.2> fully apply (May 1, 2020). These two chapters are also published in USP 41 - NF 36. 

More information can be found at the USP Homepage.