Understanding the complex inter-workings of regulatory requirements, product-package limitations, Container Closure Integrity test options, and broader control and risk mitigation strategies leading to a successful CCI program requires an experienced team.
Referring to the ability of a package or component to demonstrate suitability for its intended function, such as to protect from light and moisture or creating an adequate seal, functional and physical performance testing is a key aspect of successful package implementation and regulatory approval.
Physicochemical Testing: Assess Compatibility and Safety
Demonstrating the chemical quality and compatibility of a package system or component is crucial for patient safety and successful regulatory approval. With ever-changing regulatory expectations and test methods, CS Analytical’s experience and state-of-the-art laboratory is built for client success.
A unique offering in the contract lab market, C&C Solutions include analytical capabilities that complement standard compendial tests or tie together numerous compendial and non-compendial methods to provide a comprehensive solution to a given challenge.
Regulatory challenges and trends tend to be industry-wide. The traditional consulting model is based upon addressing the same issue for as many clients as possible. At CS Analytical, our Advisory Service packages address specific topics within a defined scope and budget, giving clients the advice and insight they need without the hassle of open-ended, hourly rate contracts.
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
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:
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.