Container Closure Integrity Testing (CCIT)

CCIT

Package Integrity is the absence of gaps/breaches in packages that could risk product quality by allowing contaminant ingress and/or product loss. Although parenteral packages must keep products sterile, package integrity is not defined as absence of microbial or liquid ingress nor product sterility. As per the proposed revisions to the USP <1207> guidelines, sole reliance on ingress tests (bubble testing, microbial and dye ingress) to confirm Container Closure Integrity (CCI) is not recommended since ingress is a probabilistic event which is difficult to control, predict and measure.

Package integrity verification requires careful examination of package leakage given the specific product and its life cycle. Cryopak Testing Center’s Container Closure Integrity division is privileged to offer the pharmaceutical and biotech companies along with their respective medical device manufacturers with the most recent deterministic capabilities. Our experienced scientists; dedicated to CCI and the full range of methods; develop, validate and execute Container Closure Integrity Testing (CCIT) methods. We can provide tailored expertise to design and execute a CCI study based on your system, providing the support you need.

CCI method selection depends upon the container system being evaluated; a single method is not suitable for all systems. Cryopak Testing Center can help. Let our experts assist with the determination of the right test method for your system.

Tracer Gas Detection, Vacuum Mode (Helium Mass Spectrometry)

Helium mass spectrometry is a deterministic test used to detect and locate small leaks. It typically uses a vacuum chamber in which a sealed container filled with helium is placed. Helium leaks out of the container, and the rate of the leak is detected by a mass spectrometer. Non-porous packaging such as vials, syringes, cartridges and flexible packaging can be tested by helium mass spectrometry using appropriate test fixture and techniques.

High Voltage Leak Detection (HVLD E-Scan 655)

HVLD is a deterministic MicroCurrent conductivity test that is non-destructive. It operates by moving a high voltage probe along the length of the package, a defect (as small as 2 microns) usually results in visible discharge through the fluid in the package, recording the defect position. Vials, syringes, cartridges and other liquid filled containers and plastic bags or pouches can be tested by HVLD using appropriate test fixture and techniques.

Frequency Modulation Spectroscopy (Headspace Analysis)

FMS-Carbon Dioxide is a deterministic, non-destructive gas analyzer for monitoring headspace concentration in sealed containers. The test that may be performed overtime to provide quantitative measure of a sample’s leak rate. It operates by passing a near-infrared diode laser light through the gas headspace region of the sealed package. Light absorption, measured using frequency-modulated spectroscopy, is indicative of gas concentration. Transparent or amber vials, syringes, and cartridges with a minimum headspace volume and headspace path length can be tested using appropriate test fixture.

Vacuum Decay

Vacuum decay is a deterministic, non-destructive test that is used to measure and verify container closure integrity of the package system by identifying package leaks that may not be visibly detectable. The VeriPac 455 is based on the ASTM vacuum decay leak test method (F2338-09) that is recognized by the FDA as a consensus standard for package integrity testing. It operates by placing the test package into an appropriate chamber that is exposed to vacuum. Sensitive pressure transducers monitor changes in the chamber pressure which results in the headspace of the package drawn through any existing leaks. Vials, screw cap bottles, auto injectors and flexible bags or pouches can be tested using appropriate test fixtures.

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