CS Analytical's New Service Offering
CS Analytical Laboratory is thrilled to announce the addition of USP 87 Biological Reactivity testing to its array of services. This enhancement in capabilities is designed to better accommodate the needs of clients in the drug product and medical device packaging sectors. By bringing this vital service in-house, the laboratory aims to deliver a more efficient and cost-effective testing program for plastic and elastomer components.
Why USP 87 Testing is Important
Biological reactivity testing plays a crucial role in determining the safety and efficacy of plastic materials used in drug packaging. USP 87 evaluates whether materials exhibit any cytotoxic effects on mammalian cells under specified conditions. This testing is essential as it helps to identify potential risks linked to chemical residues and materials before deeper investigations are conducted.
Enhanced Testing Capabilities
Previously, CS Analytical outsourced the USP 87 testing to a qualified vendor. However, by integrating this service into its operations, the laboratory can now manage testing directly within its own cGMP (Current Good Manufacturing Practice) compliant facility. This change not only reduces turnaround time but also enhances the overall quality assurance for client projects.
Comprehensive Solutions for Clients
With the introduction of in-house USP 87, CS Analytical can now offer a comprehensive testing strategy that includes both the USP 661.1 and USP 661.2 testing protocols. Chief Operations Officer Brandon Zurawlow mentioned, "By managing this service internally, we can deliver a quicker and more effective response to our clients' needs, ensuring that the testing aligns perfectly with their regulatory requirements."
How USP 87 Testing Works
The USP 87 testing process involves assessing the reactivity of materials to determine their suitability for medical applications. Each test produces graded results that help identify materials that may pose risks. This quick screening method is essential for flagging unwanted chemistries early on, allowing clients to make informed decisions regarding their materials.
Expert Guidance for Testing Methods
The team of experts at CS Analytical will work with clients to tailor testing methods to their specific needs. They will assist in selecting the appropriate techniques, be it direct contact, agar diffusion, or elution, ensuring that every project is aligned with the necessary extraction conditions. The laboratory prides itself on delivering regulatory-ready reports that place findings in the broader context of compliance.
About CS Analytical Laboratory
CS Analytical Laboratory stands out as the only FDA regulated laboratory focusing exclusively on the challenges presented by drug and medical device containers and packaging. With a team composed of industry-leading experts, the laboratory is well-versed in all applicable USP and EP requirements. Their services span a wide range of needs, from container closure integrity testing to comprehensive qualification processes tailored to specific materials, including glass, plastic, and elastomers.
Full-service Laboratory Testing
The laboratory offers extensive capabilities, ensuring products meet stringent regulatory standards through a variety of testing methods. Whether for initial feasibility studies or advanced method development, CS Analytical is a trusted partner that addresses all regulatory needs within the pharmaceutical and medical device sectors.
Frequently Asked Questions
What is USP 87 testing?
USP 87 testing assesses the biological reactivity of plastic and elastomer materials, checking for potential cytotoxic effects on mammalian cell cultures.
Why is CS Analytical now offering USP 87 in-house?
CS Analytical brought USP 87 testing in-house to provide more timely, cost-effective, and controlled testing services for their clients.
What are the protocols linked with USP 661.1 and USP 661.2?
USP 661.1 and USP 661.2 are regulatory guidelines that ensure the safety and stability of materials used in drug product packaging.
How does CS Analytical ensure data integrity during testing?
Through system-suitability controls and thorough methodologies, CS Analytical ensures that the data generated during testing is reliable and accurate.
What other services does CS Analytical offer?
CS Analytical provides a full suite of testing services, including container closure integrity testing and various compliance-related assessments for medical packaging applications.
