Closure Integrity Test

Qualification of packaging

image

Container closure integrity is defined as the ability and quality of a container closure system to provide protection and maintain efficacy and sterility during the shelf life of a productThe test is performed when qualifying a new packaging or after a change/remodelling of the packaging machinery. By assuring the closure integrity of the packaging, the risk of contamination of microorganisms or potentially reactive gases is eliminated.

We perform two different types of  Container Closure Integrity Test (CCIT):
  • Microbial Challange Test
  • Dye Penetration Test

These tests are performed under pressure for simulation of airfreight shipping.

When performing a Microbial Challenge Test, the container is filled with broth and lowered into a suspension of microorganisms. The containers are then incubated and controlled for microbial growth.

During a Dye Penetration Test, the container (with product) is lowered into a bath with methylene blue dye. A coloration of the product indicates that the packaging is leaky.

Analysis result, lead time

Analysis time is dependent on the characteristics of the sample but normally the time from sample registration to analysis report-out is 5-10 working days.