Container Performance Testing - New Proposal for USP General Chapter <671>

Recommendation

10-12 October 2023
Barcelona, Spain

Validation of Analytical Test Procedures & Measurement Uncertainty
Qualification and Validation in an uncertain analytical world – a holistic approach

In Pharmacopoeial Forum 39 (2) a proposal for the revision of USP General Chapter <671> was published. According to the summary of this change package integrity is necessary to maintain the drug product's quality throughout its shelf life. Packaging systems have to demonstrate satisfactory container-closure integrity. It is proposed that this chapter will be revised to include a new permeation method for determining barrier protection for packaging systems.

The purpose of this chapter is to provide standards for the functional properties of packaging systems used for solid oral dosage forms and liquid dosage forms for pharmaceuticals. Test methods are provided to measure moisture vapour transmission rates that are useful for pharmaceutical manufacturers to determine the level of barrier protection provided by packaging systems. Additional methods are provided to determine classification of packaging systems.

Definitions and moisture vapour transmission rates at 40°/75% relative humidity (RH)are given for the following blisters:

• Low-barrier blister - greater than 1.0 mg/cavity-day
• High-barrier blister - less than 1.0 mg/cavity-day
• Ultra-high barrier blister - less than 0.01 mg/cavity-day

Other methods may be used, if these alternative methods are described in sufficient detail to
justify their use.

More information can be found in the USP's Pharmacopeial Forum (PF).

Source: USP