We are excited to bring this service in house as means to better serve our clients as we can now offer a comprehensive test program for plastic and elastomer components in a more cost-effective and timely manner for our clients

CLIFTON, N.J., Dec. 3, 2025 /PRNewswire/ -- CS Analytical Laboratory, the world's only FDA regulated contract laboratory exclusively dedicated to providing regulatory solutions and testing services specifically for drug product and medical device package systems, is excited to announce that it has added USP 87 Biological Reactivity testing to its service offering. Biological reactivity testing for plastic and elastomer components used in drug product package systems is a requirement as outlined in the USP 661.1 chapter. CS Analytical, which previously was outsourcing this test requirement to an approved sub-contract vendor, will now perform this testing in our cGMP, FDA laboratory as a stand-alone request or as part of a comprehensive test program.

"We are excited to bring this service in house as a means to better serve our clients," noted Chief Operations Officer Brandon Zurawlow. "We can now offer a comprehensive USP 661.1 and USP 661.2 programs for plastic and elastomer components in a more cost-effective and timely manner for our clients."

USP 87 assesses whether a plastic or elastomer material shows cytotoxic effects on mammalian cell cultures under controlled conditions. Results are graded for reactivity, with system-suitability controls ensuring data integrity. This makes USP 87 an ideal screen to quickly flag risky chemistries or residues before you invest in longer, more complex programs. The CS Analytical Team of package system experts will help you choose the right method (direct contact, agar diffusion, or elution) for your geometry and risk profile; set appropriate extraction conditions; run mammalian cell assays with robust controls; and deliver regulatory-ready reports. Just as important, we place results into context—bridging to elastomer requirements (USP 381 / guidance 1381) or plastics programs (USP 661.1/661.2), and aligning with your E&L strategy (USP 1663/1664) when needed.

About CS Analytical Laboratory

The only FDA regulated, cGMP laboratory dedicated exclusively to the complex world of drug and medical device container and package qualification testing, the CS Analytical Team includes the world's leading experts on all relevant USP and EP requirements and the thought leaders and pioneers on CCI (container closure integrity – CCI) testing. Offering a full suite of laboratory services to include all USP, EP and JP procedures specific to glass, plastic and elastomers as well as complete USP 1207 services that span basic feasibility studies, component qualification programs and advanced method development and validation for helium leak testing, vacuum decay, high voltage and headspace analysis leak testing. CS Analytical is the one source that can ensure your medical product container and package system meets the strict and complex regulatory requirements.

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SOURCE CS Analytical