USP <671> Permeation Testing

USP <671> Container Performance Testing (CPT) establishes guidelines for evaluating the functional properties of packaging systems used for solid oral dosage forms (SODFs) and liquid oral dosage forms (LODFs), though tests can be applied to packages intended for other dosage forms where appropriate. Water vapor transmission (permeation) and spectral transmission (light resistance) test are the critical performance metrics, applicable if the container is intended to protect contents from light and moisture. The most current version was published by the USP Effective December 1, 2020 and multiple dose containers such as bottles and closure, single unit containers such as individual blisters or stick packs, and unit-dose containers such as blister cards with multiple cavities. At least four new test processes have been approved in the past seven years, while other methods have undergone changes and criteria have been purposely left open-ended so that manufacturers and repackagers can choose the best containers for a given product.

To successfully apply USP 671>, it is essential to comprehend the test’s purpose, the motivation behind it, and the multiple factors that may affect the reliability of the results and the applicability of the data. The Chromak Research Team can help you choose and carry out the most appropriate test plan for your particular container system because they have years of experience in USP container qualification testing.

Spectral Transmission – This test, often known as “light percent” testing or spectral transmission, is necessary for container or packaging systems that are marketed as being light resistant or designed to give light protection. In order to test plastic medication containers, a UV-Visible Spectrophotometer with a particular instrument for detecting light transmission must be used.

USP <661.1> & <661.2> Plastic Materials of Construction

Since the initial effective date, the USP has two times reversed course and delayed implementation, with the most recent delay described in a December, 2018 revision to a Notice of Intent to Revise. The current effective date is now December 1st, 2025.

The deletion of the provision that essentially “grandfathers” presently filed package systems that have received regulatory body approval is a crucial modification to these chapters. With the introduction of the implementation period, there shall be an expectation that any package included in a filing will be updated with <661.1> and <661.2> test results by the 2025 implementation date. Early adoption during the implementation period is allowed and encouraged by Chromak Research.  Early adoption of the new chapters by manufacturers avoids the time and expense of having to retest their current products. In addition, however, early adoption mitigates risk by assessing materials to a much higher standard than the outdated <661>, ultimately preventing potentially critical consequences, such as discovery of material failure during retesting that could result in drug product recalls due to unsuitable packaging use.

The Chromak Research Team was one of the contract laboratory to offer cGMP, FDA-registered services according to the new standards and they are prepared to draw upon years of practical experience to develop test plans specific to the product-package system in question to ensure all regulatory requirements are met.

Chromak Research perform the Packaging material qualifications as per client requirements and also following various standard protocols. We using USP standards for Moisture vapor transmission of plastic packaging systems and container permeation testing USP <671>, For packaging and storage Requirements USP <659>, For plastic materials of construction USP <661.1>, for plastic packaging systems for pharmaceutical USP <661.2>, for Plastic material of pharmaceutical manufacturing system USP <661.3> and Auxiliary packaging components methods USP <670>. we have years of practical experience to develop test plans specific to the product-package system in question to ensure all regulatory requirements are met.