#USA #CS Analytical #Clifton #FDA Testing #Biological Reactivity

CS Analytical Laboratory Enhances Service Offerings with USP 87 Testing

CS Analytical Laboratory, known for its exclusive focus on regulatory solutions for drug and medical device packaging, has just announced an exciting new addition to their testing services: the USP 87 Biological Reactivity testing. This move signifies a pivotal enhancement in how they assist clients in ensuring the safety and compliance of plastic and elastomer components in healthcare product packaging.

The USP 87 test is a crucial element of the standards outlined in USP 661.1, assessing whether materials such as plastics and elastomers exhibit potential cytotoxic effects on mammalian cell cultures under controlled conditions. This type of testing is increasingly relevant in the medical device industry, especially as it pertains to package systems that must meet stringent regulatory requirements. CS Analytical's decision to perform these tests in-house instead of outsourcing represents a significant step towards providing a more streamlined and efficient service to clients.

A More Comprehensive Testing Program
Chief Operations Officer Brandon Zurawlow expressed the excitement around this development, stating, "We are thrilled to bring this service in-house as a means to better serve our clients. This allows us to provide a comprehensive USP 661.1 and USP 661.2 program for plastic and elastomer components more cost-effectively and in a timely manner." Offering this capability directly enhances CS Analytical's value proposition, allowing clients to conduct testing in a single location and attach results to their broader compliance strategy.

Understanding the Importance of USP 87
The USP 87 test is not just another checkbox; it helps identify potentially harmful materials before they are used in medical devices. The grading of results for reactivity provides valuable insight into the safety profile of materials, ensuring that risky chemistries or residues are flagged early on in the design process. For enterprises investing in complex programs, being able to quickly self-assess material suitability is paramount.

The CS Analytical team, comprised of experts in packaging systems, will assist clients in selecting the most appropriate testing methods—whether in direct contact, agar diffusion, or elution. They offer guidance on setting extraction conditions, running mammalian cell assays with robust controls, and delivering reports that are ready for regulatory review. One of the distinguishing features of CS Analytical's service is the contextualization of results; by bridging to elastomer requirements (e.g., USP 381) and aligning with clients' extractable and leachable strategies (like USP 1663/1664) when required, they enhance compliance and understanding without overburdening clients.

Expertise at the Core
CS Analytical Laboratory is not just another testing facility; it is the only FDA-regulated, cGMP laboratory dedicated entirely to the specialized field of medical product container and packaging qualification testing. Their team includes leading experts on USP and EP requirements, providing a full suite of laboratory services for glass, plastic, and elastomers. These cover everything from basic feasibility studies to advanced method development and validation for testing methodologies such as helium leak testing, vacuum decay, and more.

In an environment where compliance is non-negotiable, CS Analytical represents a reliable partner for companies seeking to navigate the complexities of medical device regulations. This integration of USP 87 testing further cements its role as a critical resource in ensuring that medical packaging systems meet the demanding requirements of today's healthcare landscape.

Ultimately, CS Analytical Laboratory’s latest service expansion stands to benefit manufacturers, thereby enhancing patient safety and compliance in the healthcare industry. By centralizing biological testing and utilizing expert knowledge, they are uniquely positioned as leaders in this crucial area of medical device packaging.