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
Welcome to CS Analytical
For questions or comments:
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.
An Overview of USP 382 Testing Requirements
The new USP 382 Elastomeric Component Functional Suitability in Parenteral Product Package/Delivery Systems testing requirements, which becomes effective December 1,
The Need For Accreditations & Certifications In A cGMP, FDA Regulated Lab
CS Analytical operates in the highly regulated Pharmaceutical, Biotechnology and Medical Device marketplaces. As such, the facility and operations
USP <661.1> and <661.2> for Blister Cards – A Multi-layered Story
USP <661.1> and <661.2> - A History of Challenges When after years in the pharmacopeial forum, the proposed final drafts
News & Events
CS Analytical to Host Laboratory Tours and Client Meeting Program During NYC Interphex Week
CLIFTON, N.J. (PRWEB)April 05, 2023 CS Analytical Laboratory, the world’s only cGMP, FDA-registered and inspected contract laboratory exclusively designed
CS Analytical Hosting Educational Webinar on USP 661.1 and USP 661.2
CLIFTON, N.J. (PRWEB)March 22, 2023 CS Analytical Laboratory, the world’s only FDA regulated contract laboratory exclusively dedicated to providing
CS Analytical Expands Service Offering for New USP 382 Testing Requirements
CLIFTON, N.J. (PRWEB)January 25, 2023 CS Analytical Laboratory, the world’s only FDA regulated contract laboratory exclusively dedicated to providing regulatory