Pharmaceutical products are vital to society to ensure a high level of patient efficacy and safety. Quality standards are required to ensure pharmaceutical deliverables, intended to serve public health, are suitable and appropriate. As per the United States Pharmacopeia (USP), a plastic packaging system intended to hold pharmaceutical deliverables can interact chemically with drug formulations and compositions, potentially impacting safety and performance.
The USP has introduced two new chapters, USP 661.1 and USP 661.2, both intended to improve the quality design process for the characterization of plastic raw materials and improve the quality assessment of finished plastic packaging systems.
For several years, USP <661> provided general guidelines for plastic packaging materials and systems. However, as materials of construction and packaging systems evolved, it became clear that the existing standards within <661> were no longer sufficient. To address these gaps, USP 661.1 and 661.2 went into effect at the beginning of December 2025. According to the USP, those standards will introduce the following concepts:
- An established approach tailored to specific risk applications.
- Methodology enhancements targeted to improve the procedures related to physiochemical, biological, identification, and extractable testing for plastic raw material and storage systems.
- Enhanced analytical standards and specifications for plastic raw materials and plastic packaging.
This approach provides an enhanced mechanism to ensure the upmost quality and analytical assessment of plastic packaging, reassuring quality compliance and unadulterated pharmaceutical deliverables.
Key impacts to the industry:
- A qualified process for selecting suitable plastic raw materials based on pharmaceutical application.
- Updated methodology to enhance testing procedures and incorporate Total Organic Carbon evaluations.
- Integrated extraction temperature conditions suitable for various plastic packaging systems and components.
- A quality reassessment design for extractables and leachable protocols based on risk application.
How Eurofins empowers your plastic packaging compliance journey
Eurofins is a global leader in analytical testing and regulatory support for raw materials testing. Our end-to-end services help you navigate USP 661.1 and USP 661.2 with confidence. We are implementing the updated standards and already have these in place for clients who chose to adopt early the new USP standards.
Supporting USP 661.1: Plastic materials of construction:
We provide analytical support, expertise, and qualified instrumentation to meet the requirements of USP 661.1 through:
- Analytical testing across a variety of methods to support compliance.
- Comprehensive platform approach for characterization, identification, and quantification of elemental impurities.
- Biological testing to confirm material safety per USP <87> regarding material toxicity.
Supporting USP 661.2: Plastic packaging systems
We provide analytical support, expertise, and strategic guidance to help assess unique packaging system configurations to meet the requirements of USP 661.2 through:
- Direct collaboration with customers to ascertain a strategy to meet USP requirements and client expectations based on rationale and justification within the USP scope.
- Industry-targeted strategies built on USP foundations to test unique packaging applications.
- Customized Extractable and Leachable services tailored to your product and packaging system, that meet USP standards and are grounded in a risk-based approach.
- Capability to implement and support the biological testing components of the new USP standard.
Our experts collaborate to develop testing plans specific to the material in accordance with USP standards. By partnering with us, you’ll streamline your transition to the new USP standards, safeguard product integrity, and be positioned to maintain uninterrupted market workflows.
For more information visit: www.Eurofins.com/BPT or: Contact-Us to submit an inquiry.