We are thrilled to have CS Analytical join the expanding Contract Laboratory Network. As the only cGMP, FDA-regulated laboratory exclusively dedicated to container and package testing for the pharmaceutical, biotechnology, and medical device industries, CS Analytical brings unparalleled expertise in ensuring product safety, quality, and regulatory compliance.
About the Organization
Located in Clifton, New Jersey, USA, CS Analytical specializes in comprehensive container and package testing solutions. Their services include method development, validation, analysis for container closure integrity (CCI), USP/EP/JP physical performance tests, and physicochemical tests for primary packaging components focusing on regulatory compliance.
Want to outsource your lab testing to CS Analytical? Simply submit your laboratory request and get started!
Services Provided by CS Analytical
- Container Closure Integrity Testing (CCIT): Custom container closure solutions using methodologies, such as laser-based headspace analysis, USP <1207> helium leak detection, high voltage leak detection, and vacuum decay.
- Functional Performance Testing: Assessing suitability for intended functions, including permeability, desiccant adsorption, elastomer functionality, gas transmission, and seal integrity testing. Specific tests include USP <671>, USP <660>, USP <670>, USP <382>, oxygen and moisture transmission, and USP <1207>.
- Physicochemical Testing: Evaluating the chemical quality and compatibility of packaging systems. Specific tests include USP <661.1> Plastic Materials, USP <661.2> Plastic Containers, USP <660> Glass, USP <381> Elastomers, and USP <1663 / 1664> Extractables and Leachables testing.
- Comprehensive and Complementary Services (C&C Services): Advanced optical and digital imaging, capping optimization studies, cold storage studies, package distribution testing, and storage and stability testing. These services provide a complete solution for package development challenges.
- Advisory Services: Identifying regulatory challenges and trends in the pharma, biotech, and medical device industries, and building solution-oriented packages to address them. Services include Comprehensive Container Qualification Strategy Review (CCQSR), Maximum Allowable Leakage Limit (MALL) Determination, CCI Strategy Review (CCISR), and CCI method selection, development, validation, or transfer.
Industries They Serve
This cGMP testing facility provides critical support to ensure regulatory compliance and product integrity across a range of industries.
- Pharmaceutical Industry: Comprehensive testing solutions for the pharmaceutical industry packaging, including container closure integrity testing and physicochemical testing, to ensure the safety and efficacy of pharmaceutical products.
- Biotechnology Industry: Advanced testing services support the biotechnology sector in maintaining regulatory compliance and ensuring product quality, particularly for innovative biotech solutions.
- Medical Device Industry: Specialized testing for medical device packaging to ensure they meet stringent regulatory standards for safety and performance.
- Consumer Products Industry: Ensure consumer products meet safety and quality standards, enhancing consumer trust and regulatory compliance.
- Packaging Industry: The company’s core service—ensures that packaging materials and solutions are robust, compliant, and reliable, catering to various industries’ needs.
Work with CS Analytical
CS Analytical is dedicated to advancing product safety and quality with accredited facilities, and a team of highly skilled and qualified experts. To leverage their expertise and comprehensive services, submit a lab request today!
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