CS Laboratory Adds Dual Instruments! Medical Plastic Additive Testing Aligned with USP 661.1 New Standards

The CS Analysis Laboratory has added two new instruments to enhance its testing capabilities for plastic additives, fully complying with the new USP 661.1 standard, which sets the testing requirements for single plastic materials used in drug and medical device packaging. The laboratory stated that the newly added High-Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC) instruments will play a key role in the detection of plastic additives as stipulated by USP.

As the only FDA-regulated contract laboratory specializing in regulatory and testing services for pharmaceutical and medical device packaging systems, Ronak Patel, the manager of the Chemical Services Laboratory, stated: "The CS analytical team must be prepared to assist our clientele in tackling these novel and more complex testing methods, especially when it comes to plastic additives." "The addition of HPLC and gas chromatography capabilities enables us to achieve this goal."

CS Analytical explains that USP 661.1 is a standard for testing individual plastic materials used in pharmaceutical packaging to confirm their identity, bioreactivity, general physicochemical properties, and composition. This test ensures that the raw materials can be adequately characterized and are suitable for their intended use before being used to manufacture components. Key aspects of the test include evaluating bioreactivity, determining physicochemical properties, and confirming the identity of plastic resins and additives. The test methods have been updated to USP 661.1 and USP 661.2, effective from December 1, 2025.

CS Analytical currently offers comprehensive USP 661.1 and USP 661.2 testing services for all types of plastic materials potentially used in the production of plastic containers and packaging systems. Whether it's traditional high-density polyethylene (HDPE) bottles for solid oral dosage forms, unique drug delivery systems, or complex and large-sized intravenous infusion bag systems, CS Analytical states that they have the development capabilities and practical experience to create qualification testing programs that ensure all development goals and compliance metrics are met.