Complete USP 1207 CCI method development, validation, and analysis

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

Welcome to CS Analytical

For questions or comments:
engage@csanalytical.com

Live Q&A Session | A Deeper Dive into USP <661.1> & <661.2>

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Our Services

ADVISORY

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.

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ANALYTICAL

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.

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COMPREHENSIVE

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.

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