Over the past decade, the landscape for establishing a container closure integrity test has progressed drastically. With the revision of USP <1207> (2016), the client’s strategy to develop CCIT methods throughout their specific products package life cycle can be challenging.
A container closure integrity test method must be able to determine leakage given the specific product and its life cycle. DDL’s CCI services cater to the biopharmaceutical industry with their respective product package systems from the start. Leveraging DDL’s expansive chamber suite, we can provide high-quality CCI stability programs under one roof.
To establish container closure integrity into the product package life cycle requires a uniquely developed test method to inspect for defects thoughout the product-package life cycle. DDL can assist you with the determination of the right test methodology and provide the quality of testing required to meet your expectations.
DDL provides comprehensive method development and validation to provide a uniquely tailored CCI test specific to your needs. To provide exceptional service and to meet expectations, project timelines are secured and managed from the start. Through the means of our feasibility process, work is conducted to determine the candidacy of the test methodology and any risks allowed or any associated risks to the integrity of the parenteral packaging system.
DDL’s deterministic testing technologies include the following:
- Leak Detection Associates SIMS 1284+ Helium Mass Spectrometer – As one of the most versatile instruments, the SIMS1284+ provides helium leak rates for a myriad of package systems. While under vacuum, pass-fail criteria for the risk of microbial ingress can be evaluated to establish inherent integrity, as well as the impact of assembly process parameters. Collaboration with the experts at LDA has allowed unique package systems to be assessed, as well as the capability to test directly at temperatures of -80C.
- PTI E-Scan 655 High Voltage Leak Detection – A highly sensitive instrument that leverages MicroCurrents for the detection of defects in liquid-filled package systems. This non-destructive test is highly responsive, with a submicron limit of detection. It has become popularized with pre-filled syringes as well as liquid-filled vials and syringes for reliable long term testing.
- PTI Veripac 465 Vacuum Decay Microleak Detector – As one of the most robust deterministic testing technologies, this non-destructive test methodology can detect defects in the submicron region. With PTI’s capabilities to fabricate fixtures and flexible chambers, CCI test methodologies can be established with autoinjectors and vials filled with liquid or solid products. Additionally, test methodology for unique and even flexible package systems such as IV bags and other complex devices have been successfully established, allowing DDL to provide solutions for most package systems.
- Head Space Analyzer– Used heavily in lyophilized product package systems, evaluation of the headspace concentration is used to determine the presence of leaks in the primary package system. With laser diodes tuned to a specified frequency, oxygen concentration and C02 concentration can be rapidly obtained. This non-destructive test methodology allows for evaluation of CCI for long term testing, cold storage shipping, and even cryogenic impacts of the integrity of the package.
Contact us for more information or to talk to an engineer.