Pharmaceutical packaging requirements tend to evolve along with processes and materials. At the center of these developments is the United States Pharmacopeia (USP). This organization is a world-renowned nonprofit organization responsible for addressing quality assurance, increasing regulatory predictability, and helping pharmaceutical companies distribute safe healthcare products.
In the studies conducted in 2020, revisions were made to eliminate the uncertainties of the USP 661 standard and to make the tests more specific and effective, and the USP 661.1 and USP 661.2 standards emerged. It is expected that the current USP 2025 standard will expire at the end of 661 and the USP 661.1 and USP 661.2 standards will come into full force.
To create the specificity required for the quality and safety of pharmaceutical packaging, the USP 661 standard is divided into two:
The USP 661.1 standard includes more stringent standards for safe testing and verification of the use of raw materials in healthcare product packaging to minimize risk in both low-risk (topical/oral dose) and high-risk (injections, inhalations, suppositories, etc.) products.
Requirements focus on materials that are direct contact, non-direct contact and non-interacting, and compatible with specific polymers:
USP 661.1 tests verify the properties of these polymers in four areas:
However, due to the large number of potential variables that exist (including those presented by most flexible packaging), there is a category of unaddressed materials. If packaging materials fall into this category, it is up to the pharmaceutical company and the packaging partner to determine what features are adequate.
Meanwhile, it is important to note the following:
Passing USP 661.1 testing does not guarantee the use of materials as each packaging system is different.
The tests covered in USP 661.2 largely mirror the physical-chemical and biocompatibility aspects of USP 661.1 for low-risk and high-risk healthcare product packaging, but there is an important difference. USP 661.2 includes an assessment of chemical compatibility and safety using comprehensive extractable and leachable tests. This standard is not intended to replace ISO 1663 and 1664, which address these test methodologies. Instead, USP 661.2 addresses,
Among the numerous testing, measurement, analysis and evaluation studies that our organization has carried out for businesses in various sectors, it also provides testing services defined in the “USP 666.1/2 Plastic packaging systems and building materials” standard with its trained and expert staff and advanced technological equipment.
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