Whole Package Integrity Test

According to ISO 11607, a validatable package-testing process must include both package-integrity testing and seal strength testing. STEMart provides various whole package integrity tests to help manufacturer ensure that the package provides a microbial barrier between the medical device and the external environment.

• ISO 11607
• ASTM

• Strength Test
• Seal-strength testing

Determines the seal strength of peelable package by pulling the sample apart with a moving jaw at a constant speed while measuring the resistance force during seal separation.

• Burst testing

Measures the minimum seal strength by pressurizing the entire package and capturing the peak rupture pressure.

• Creep Test

Determines the seal-strength by pressurizing the entire package to a predetermined level (less than that required to burst the package) and held over a defined time period.

• Vacuum deflection test

Detects leaks in blister packs by measuring the deflection of surface in response to an applied vacuum.

• Integrity Test
• Dye penetration test

Detects leaks in edge seals through a nonporous package by injecting a sealed non-porous package with a dye solution and then visually observing any capillary movement of the dye through the sealed area.

• Mass extraction leak test

Checks the leak of container by placing the container under vacuum in a mass extraction test instrument, and then comparing the mass flow values with the predetermined leak threshold.

• Pressure decay test

Measures leaks in nonporous film, foil, or laminate flexibles and foil-sealed trays by measuring change (decay) in pressure applied on the package over time.

• Vacuum decay test

Detects package leaks by measuring the rise in pressure (vacuum loss) in an enclosed evacuated test chamber in which the test package is placed.

• Tracer Gas Detection (Vacuum Mode)

Detects the leaks as small as 0.2 microns by quantitating the flow rate of helium or hydrogen from leaks in container after having been charged with helium or hydrogen as a tracer gas with mass spectrometer.

• Tracer Gas Detection (Sniffer Mode)

Locates the leaks of container by scanning across a test part which has been 'soaked' in hydrogen or helium in a saturation chamber with gas sensor.

STEMart provides comprehensive whole package integrity test to support manufacturers to meet the regulatory goals, and minimize the compliance risks. If you have any additional questions about Container Closure Integrity Test or would like to consult with the experts at STEMart, please feel free to contact us.

Reference

• STANDARD, BRITISH, and BSEN ISO. "Packaging for terminally sterilized medical devices." (2006).