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
ASTM 1980 Accelerated Aging Testing
The ASTM F1980 Standard Guide for Accelerated Aging of Sterile Medical Device Packages is a test procedure that can
An Overview of Package Validation & Distribution Testing
A medical product package system must meet regulatory requirements as outlined under the ISO 11607 guidelines which clearly state that
Understanding the Requirements for USP Container & Package Testing
In review of the current and pending requirements for USP qualification testing of a drug or medical device package system,
News & Events
CS Analytical Continues Growth With USP 1207 CCIT Hires
CLIFTON, N.J., Dec. 4, 2024 /PRNewswire/ -- CS Analytical Laboratory, the world's only FDA regulated contract laboratory exclusively dedicated to providing
CS Analytical Issues Guidance on Pending USP 661.1 and USP 661.2 Implementation Date
CLIFTON, N.J., Oct. 8, 2024 /PRNewswire-PRWeb/ -- CS Analytical Laboratory, the world's only FDA regulated contract laboratory exclusively dedicated to providing regulatory
CS Analytical Partners with Contract Laboratory to Host Webinar on Package System Regulatory Testing Requirements
CLIFTON, N.J., Sept. 18, 2024 /PRNewswire-PRWeb/ -- CS Analytical Laboratory, the world's only FDA regulated contract laboratory exclusively dedicated to