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Testing of container closures is important as it ensures a sterile barrier against microorganisms and other potentially dangerous contaminants. Containers and closure systems receive testing of both primary, components that come into direct contact with a product, and secondary packaging components, those most important for ensuring the packaging is assembled correctly.

At Gateway Analytical, we specialize in providing only non-destructive, deterministic CCIT methods to serve our pharmaceutical and biotechnology customers best.

Specialty Areas of Expertise:

• CCI using the CO2 overpressure vessel and CO2 analyzer.
• CCI for lyophilized products packaged under vacuum.
• CCI for products stored on dry ice.
• CCI for products stored in the vapor phase above liquid nitrogen.
• CCI for products purged with an inert gas at one atmosphere of total pressure.

USP defines essential terms such as container-closure integrity (CCI), which refers to a package's ability to prevent product loss, block microorganism ingress, and limit the entry of detrimental gases or other substances. Container-closure integrity testing (CCIT) refers to any package leak test that detects the presence of a package breach or gap. A container-closure system (CCS) is the sum of CCS components and materials containing and protecting the article, including primary and secondary packaging components when required to provide additional protection.

Gateway Analytical Instrumentation

LIGHTHOUSE’s FMS-Oxygen Headspace Analyzer measures oxygen concentration in sealed parenteral containers. The benchtop headspace oxygen analyzer can be used throughout the entire product lifecycle, from development to QC laboratory applications to at-line, in-process control of headspace oxygen levels and production.

Applications Include:

  • Leak detection
  • Container closure integrity studies
  • IPC monitoring of oxygen levels during the filling of oxygen-sensitive product
  • Optimization and validation of purging systems on filling lines
  • Oxygen degradation studies
  • Stability trends, end-of-shelf life studies
  • Packaging permeation studies

LIGHTHOUSE’s FMS-Carbon Dioxide (CO2) Headspace Analyzer measures CO2 concentration in sealed parenteral containers for a variety of applications. The benchtop headspace carbon dioxide analyzer can be used throughout the entire product life- cycle, from development to QC laboratory applications to at-line, in-process control of headspace CO2 levels in production.

Applications include:

  • Container closure integrity testing of frozen product stored on dry ice for transport
  • General container closure integrity testing when the test method involves using carbon dioxide as a tracer gas
  • IPC monitoring of carbon dioxide levels during the lling of product purged with carbon dioxide in the headspace
  • Microbial growth detection in media vials

 

The most significant effect of the delineation between probabilistic and deterministic CCIT methods comes from regulatory agency scrutiny. Regulatory agencies expect companies to select deterministic CCIT methods instead of probabilistic methods such as tracer liquid (dye ingress) or the microbial ingress challenge due to the availability of deterministic CCIT methods with greater quantification and the lowest detection limits.