WHO WE ARE
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.
CONTAINER TESTING
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
CONTAINER CLOSURE INTEGRITY TESTING
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 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’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 <1207> Helium Leak Testing
The USP <1207> Package Integrity Evaluation of Sterile Products provides an overview of relevant and acceptable test methods that may
Differentiating USP <671> Permeation Test Methods – Part Two
In this two-part series, we are providing detailed information and test method highlights to help you understand the permeation testing
Differentiating USP <671> Permeation Test Methods – Part One
Understanding the permeation testing requirements of the USP <671> Container Performance Testing chapter can be a challenge. Over the past
News & Events
CS Analytical Laboratory Announces Formation of New C&C Solutions Group
CLIFTON, N.J. (PRWEB)February 24, 2021 CS Analytical Laboratory, the world’s only cGMP, FDA-registered and inspected contract laboratory exclusively designed and
CS Analytical Laboratory Establishes Advisory Services: a Unique Way to Better Serve Clients
CLIFTON, N.J. (PRWEB) FEBRUARY 03, 2021 CS Analytical Laboratory, the world’s only cGMP, FDA-registered and inspected contract laboratory exclusively designed and
Sandra Cincotta Named Director of Quality for CS Analytical Laboratory
CLIFTON, N.J. (PRWEB) JANUARY 20, 2021 CS Analytical Laboratory, the world’s only cGMP, FDA-registered and inspected contract laboratory exclusively designed and