Container Closure Integrity Testing (CCIT)
Container closure integrity testing is done to evaluate the strength and integrity of a container closure system.
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.
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.
Gateway Analytical Instrumentation
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.
- 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
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.
- 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
Test in accordance with ISO 11040-4 Annex E
Determines the break-loose force and glide force for hypodermic syringes and other similar drug delivery systems. Through force measurements, the quality and consistency of silicone oil lubrication within the syringe can also be assessed.
Test in accordance with ISO 11040-4 Annex F
Determines the force required for a needle to penetrate through a rubber stopper or a standardized film similar to human tissue. Numerous test speeds are available including 20mm/min and 200mm/min.
Test in accordance with ISO 11040-4 Annex G1
Assesses the fixation of the needle to the syringe. Verifies that the needle bonding process is appropriate and the pull-out force is proportional to the needle size in accordance with ISO 7864. Gripping the needle with a vice, a test speed of 50mm/min is applied until the needle is removed from the syringe or broken and maximum force is determined.
Test in accordance with ISO 11040-4 Annex G
Assesses the liquid leakage resistance of the closure systems (needle shield or tip cap/ barrel assembly) by applying an internal pressure of 110 kPa to the syringe for 5 seconds. This verifies whether the closure system can withstand any overpressure inside the syringe during the filling process or during transportation.
Test in accordance with USP <1207>
Determines the force with which the rubber stopper between the flanged cap and the neck of the vial is braced. This non-destructive method evaluates seal tightness in stopper/seal combinations. The value provides an indication of the vials current closure security. Vial diameters from 15mm to 70 mm can be tested using this method. RSF values can also validate crimping machines by testing different settings and stopper/seal combinations.
Test in accordance with ISO 11040-4 Annex G6, Method 1
Determines the force required to remove the tip cap or needle shield from a syringe. Numerous test speeds available including 100mm/min and 1000mm/min.