Draft USP Chapter <671> Containers - Performance Testing

A revised version of general chapter <671> Containers—Performance Testing has been published in Pharmacopeial Forum 43(1) [Jan.-Feb. 2017]. Comments will be accepted until March 31, 2017, the end of the comment period for Pharmacopeial Forum (PF) 43(1).

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

  • Completely reorganize the chapter to clearly delineate the sections on the scope of the classification systems,
  • Consolidate the classification tests for blisters and packs,
  • Delete 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]. 

Additionally, minor editorial changes have been made to update the chapter to current USP style.

The following chapters reference the general chapter <671> under revision and need to be reviewed to keep references to <671> accurate:

  • <7> LABELING 
  • <659> PACKAGING AND STORAGE REQUIREMENTS
  • <795> PHARMACEUTICAL COMPOUNDING—NONSTERILE PREPARATIONS
  • <1136> PACKAGING AND REPACKAGING—SINGLE-UNIT CONTAINERS 
  • <1151> PHARMACEUTICAL DOSAGE FORMS
  • <1177> GOOD PACKAGING PRACTICES 
  • <1178> GOOD REPACKAGING PRACTICES

Other monographs and/or chapters may also be listed, even where the reference to <671> remains unchanged, as additional notice to stakeholders where there is believed to be potential for the change in <671> itself to affect pass-fail determinations for particular monograph articles.

It is the purpose of this chapter to provide standards for the functional properties of packaging systems used for solid oral dosage forms (SODF) and liquid oral dosage forms (LODF). The tests that follow are provided to determine the moisture vapor transmission rate (water vapor permeation rate) for plastic packaging systems for manufacturers, packagers, and repackagers. This chapter also includes a classification system for plastic packaging systems that allows pharmacists and institutional repackagers to select appropriate containers to repackage SODFs and LODFs. Definitions that apply to this classification system are provided in Packaging and Storage Requirements <659>.

The revised chapter is structured as follows:

INTRODUCTION  
MOISTURE VAPOR TRANSMISSION FOR PLASTIC PACKAGING SYSTEMS 
- Introduction  
- Desiccant Method for Packaging Systems for Oral Dosage Forms   
CLASSIFICATION SYSTEM FOR PLASTIC PACKAGING SYSTEMS 
- Introduction  
- Packaging Systems for Solid Oral Dosage Forms and Liquid Oral Dosage Forms  
- Packaging Systems for Liquid Oral Dosage Forms   
GLOSSARY 

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.

Recently, the omission of the "well-closed" specification from <671> has been proposed. However, the method for measuring the permeation of water vapor in multiple-unit containers for SODF in section CLASSIFICATION SYSTEM FOR PLASTIC PACKAGING SYSTEMS of the current draft still provides two acceptance criteria for containers, defined as “tight” and “well-closed”.

Following your registration on the USP website you can get to the complete draft of <671> Containers—Performance Testing. 

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