KEY WORDS, Setup for Injection Simulation Testing, Regulatory references, Interpretation of break-loose and glide force (BGF) graphs
Horst Koller, HK Packaging Consulting GmbH, Weinbergweg 1, 8730 Uznach (Switzerland), e-mail: firstname.lastname@example.org
Prefilled cartridges and syringes are widely used within the pharmaceutical industry for the administration of drug product depending on route of administration and intended use. Such container closure systems (CCS) undergo a stringent qualification and quality control with regard to protection of drug product (DP), compatibility between CCS and DP, safety and performance.
A prefilled cartridge or syringe is always a multicomponent system and requires a safe and reliable handling during (...)