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.
C&C solution programs can be built incorporating numerous techniques, analytical, storage, and otherwise, to address package development challenges in a complete manner, such as
- 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
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, howeer, 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 deliverable.
Whether looking to characterize or define a specific manufacturing parameter like application torque, challenge a heat sealed pouch with accelerated aging conditions, or to execute a broad container qualification program covering all relevant tests for a given component or package system, CS Analytical is ready to dedicate industry expertise, state-of-the-art laboratory equipment, and a cGMP, Part-11 compliant electronic quality system for client success.