Aptar Pharma launches system-level data for injectable packaging
Key takeaways
- Aptar Pharma has introduced a system-level data package for assembled injectable drug delivery systems.
- The package supports compliance with USP <382>, which requires pharmaceutical packaging to be evaluated as a fully assembled system.
- Initial applications cover pre-filled syringes using Aptar Pharma needle shields and coated plungers for sensitive and highly viscous biologics.
Aptar Pharma has announced a system-level data package for injectable drug delivery systems to aid customers in making “more informed” development decisions. In collaboration with its partners, the data package combines system-level testing and performance data, such as container closure integrity and sealing requirements, for injectable therapies.
According to Aptar Pharma, container closure systems are usually assessed separately by component, requiring coordination across suppliers. It adds that this can make it challenging for customers to establish a “complete view” of assembled-system performance early in the production stage.
Aptar Pharma underscores how US regulation USP <382> (Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems) requires pharmaceutical packaging to be tested on the fully assembled system rather than individual components. It came into effect on December 1, 2025.
“As injectable therapies become more complex with the rise of biologics and combination products, USP <382> places greater emphasis on system-level understanding,” says Audrey Chardonnet, VP global market development, at Aptar Pharma Injectables.
“Our approach is designed to help customers make more informed development decisions while preserving the flexibility required for different molecules and formats.”
The information aims to support earlier container decisions with relevant information, inform internal testing strategies, and build confidence in assembled-system performance before scale-up.
Supporting pharma packaging
Aptar Pharma develops a wide range of medical solutions and works with partners across the injectable value chain, including pre-filled syringe (PFS) producers.
“The current focus is on partner PFS platforms incorporating Aptar Pharma rigid needle shields and PremiumCoat elastomeric plungers for sensitive drug formulations, including highly viscous biologics,” outlines the company.
Recently, Aptar Closures introduced a suite of closures to support beauty, personal care, and home care brands in meeting the increasing demands of e-commerce packaging.
Meanwhile, Aptar Active Material Science secured a US patent for its N-Sorb technology to reduce nitrosamine impurities associated with packaging pharmaceuticals.
In a recent conversation with Packaging Insights, Aptar Beauty told us about the process of integrating AI into its beauty packaging processes, arguing that it acts as a “catalyst for innovation, feeding strategic thinking and guiding development paths to design solutions that meet real needs and unspoken desires.”
