Located in Clifton, New Jersey, CS Analytical represents the only cGMP, FDA-regulated laboratory exclusively designed and built to serve the container and package testing needs of the pharmaceutical, biotechnology, and medical device industries. The CS Analytical Team includes world-leading experts when it comes to regulated container qualification testing. The mission of the CS Analytical team is simple: share their experience, knowledge and commitment to regulatory compliance with each client and bring “exceeds expectations” service back to the contract lab market, which has seen a decline in consultative competency and customer satisfaction over recent years. Test services offered will cover CCI method development, validation, and analysis, as well as USP/EP/JP physical performance tests and physicochemical tests for all common or unique primary packaging components and systems.
CS Analytical advises clients on testing strategies and approaches, while delivering unparalleled analytical services to deliver a comprehensive qualification package. All relevant USP, EP, and JP testing procedures will be offered. Examples of common tests include:
- USP 381 / USP 382 Elastomeric Components
- USP 660 Containers – Type 1, 2, 3 Glass
- USP 661 / 661.1 / 661.2 Plastic Packaging Systems
- USP 671 Containers – Moisture Vapor and Spectral Transmission
- EP 3.1.3 Plastics for Pharmaceutical Use
- EP 3.2.9 Rubber Closures for Parenterals
A leadership team consisting of the creators of the world’s first comprehensive CCI lab, CS Analytical is dedicated to providing advisory, developmental, validation, and routine CCI analysis services based upon current USP <1207> methodologies including:
- Laser-based headspace analysis
- Helium leak detection
- High voltage leak detection
- Vacuum decay
Our Services
Regulatory challenges and trends tend to be industry-wide. CS Analytical’s Advisory Service packages address specific topics within a defined scope and budget, providing advice and insight without the hassle of open-ended, hourly rate contracts.
Test services offered will cover Container Closure Integrity method development, validation, and analysis, as well as USP/EP/JP physical performance tests and physicochemical tests for all common or unique primary packaging components and systems.
CS Analytical’s Comprehensive and Complementary Services (C&C Services) include those analytical capabilities that complement CS Analytical’s standard compendial test offerings or tie together numerous compendial and non-compendial methods to provide a comprehensive solution to a given challenge.
Latest Blogs
USP <87> Is Changing — What the Expanded In Vitro Framework Means for Pharmaceutical Packaging
USP <87> has long been associated with cytotoxicity testing, and for many pharmaceutical packaging teams it was historically treated
Why Pharmaceutical Packaging Biocompatibility Is Moving Beyond Checklists
For decades, biocompatibility testing for pharmaceutical packaging followed a predictable and largely inherited pattern. Specifications referenced familiar biological tests,
USP <87> Biological Reactivity (In Vitro): A Smart Cytotoxicity Screen for Plastics & Elastomers; From Early Characterization to Release
Biocompatibility isn’t a box to check; it’s a continuous thread that runs from early material selection through commercial release.
News & Events
CS Analytical Adds USP 87 Biological Reactivity Testing to its Service Offering
We are excited to bring this service in house as means to better serve our clients as we can
By Popular Demand CS Analytical Hosting Q&A Webinar on USP 661.1 and USP 661.2
In follow-up to the sold out webinar we hosted on October 29th, this one hour live question and answer
CS Analytical Expands USP 661.1 Service Offering with HPLC & GC Instrument Capabilities
With the USP formally implementing a series of test method updates to USP 661.1 and USP 661.2 effective December




