Initially made effective May 1st, 2016 (and subsequently delayed), General Chapters <661.1> and <661.2> were introduced to improve upon the robustness of chemical characterization testing for plastic materials and package systems versus the outdated <661> chapter they intend to replace. In addition, the new test chapters provide testing options for a more diverse set of materials, such as Cyclic Olefins, not adequately characterized by old methods.
In short summary, USP <661.2> is intended to evaluate a composite plastic package system or components, compared USP <661.1>, which evaluates plastic materials of construction from which package components or systems are created. To use an analogy, USP <661.1> is like testing cake batter. USP <661.2> testing is like testing the Bundt cake, cupcake, or sheet cake created using that specific formulation of batter.
The <661.2> chapter applies specifically to plastic packaging components and systems used for packaging final drug products. Associated components, as defined in <659>, are not within scope. A product’s packaging component or system is deemed chemically suited for its intended use, if it meets the requirements in <661.2>. The packaging component or system should be constructed from well-characterized materials as defined in <661.1> and is chemically suited for its intended use if:
- general physicochemical properties have been established
- biological reactivity has been appropriately established
- The packaging component or system has been established to be suitable by means of the appropriate chemical suitability, including extractable and leachable assessments as required on a product-to-product basis
Plastic packaging components and systems can vary widely in terms of their configuration, materials of construction, and their potential use. Because of this, it is challenging to provide universally effective and efficient tests methodologies, lists of target elements and reporting requirements. As such, a custom-defined test approach is key to success.
Since the initial effective date, however, 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.
A key revision to these chapters is the removal of the clause that effectively “grandfathers” currently filed package systems that have been approved by a regulatory body. 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 CS Analytical.
Manufacturers that choose to adopt the new chapters early save time and cost associated with retesting existing materials. 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 resulting in drug product recalls due to unsuitable packaging use.
The CS Analytical Team was one of the first in the contract laboratory market to devise and offer cGMP, FDA-registered services according to the new standards and are ready to leverage years of hands-on experience to devise test plans according to the specific product-package system in question to ensure all regulatory requirements are met.