We are excited to be at the forefront of this type of service offering. As the container and package regulatory landscape evolves, there has been an explosion of new systems that do not directly fit the older and more simplified qualification requirements
CLIFTON, N.J. (PRWEB) February 24, 2021
CS Analytical Laboratory, the world’s only cGMP, FDA-registered and inspected contract laboratory exclusively designed and dedicated to container testing for the pharmaceutical, biotechnology, and medical device industries, officially announced today the formation of a new service unit: Comprehensive & Complementary (C&C) Solutions to offer clients unique services and custom-built qualification testing packages to address specific client challenges in a comprehensive manner. 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.
C&C solution programs can be built incorporating numerous techniques, analytical, storage, and other critical, but often overlooked, tests to address package development and qualification challenges in a complete manner. Examples include:
- Advanced optical and digital imaging to dial in component dimensions for vials, stoppers and seals, as well as cartridges with elastomeric combi-crimp seals.
- Capping optimization studies incorporating multiple crimp force variables, component dimensional analysis including stack-up tolerances, residual seal force (RSF), and leak testing as per one of the various USP〈1207〉deterministic technologies for container closure integrity testing (CCIT).
- Cold storage studies at -80°C or lower to replicate storage or shipment on dry ice, liquid nitrogen deep storage or vapor phase, or mechanically down to -150°C, including leak test techniques and dimensional and capping considerations as mentioned above
“We are excited to be at the forefront of this type of service offering. As the container and package regulatory landscape evolves, there has been an explosion of new systems that do not directly fit the older and more simplified qualification requirements,” stated Brian Mulhall, CEO of CS Analytical. “Our focus and dedication with this line of service will enable clients to develop comprehensive qualification programs that complements and enhances the existing regulatory requirements specific to their components.”
C&C solutions “stack”. They can be completed individually to complement other studies or initiatives, such as using digital imaging as part of an investigation, or dimensional analysis as part of vendor qualification. They can be completed in tandem or sequence, however, to yield comprehensive solutions incorporating all relevant USP, EP, and complementary tests to provide a complete, robust, and fully cGMP data package to qualify a package component or system. Furthermore, C&C solutions can be combined with CS Analytical’s Advisory Services – providing expert consultative advice taking C&C solutions from concept, to creation, to execution and deliverables. In addition, the ability to develop, validate or transfer client-specific methods will be offered. C&C Solutions collectively provide clients a one stop approach to container and package system validation that incorporates the standard USP and EP methods routinely used with a wide variety of options specific to their unique product, package, and process.
About CS Analytical Laboratory
The world’s only cGMP, FDA-registered contract laboratory exclusively designed and dedicated to container testing for the pharmaceutical, biotechnology, and medical device industries, the CS Analytical Team includes world-leading experts and thought-leaders on FDA and EU regulatory expectations and USP and EP primary package testing requirements inclusive of container closure integrity (CCI) testing (CCIT). Test services include CCI method development, validation, and analysis, USP/EP/JP physical and physicochemical testing, and Comprehensive and Complementary services for all common or unique primary packaging components and systems inclusive of glass, plastic, elastomeric, and more. CS Analytical is the single source to ensure a regulated industry product-package system meets strict, complex, and ever-changing regulatory requirements.