Container Closure Integrity Testing Services

Why Choose Eurofins BioPharma Product Testing?

• We have more than 15 years of experience developing  and executing methods for various container types.
• We have completed hundreds of container closure  testing projects.
• We provide quick turnaround time on method development  for dye ingress testing (in as little as two weeks).
• We offer generic in-house procedures, as well as customized  approaches for microbial immersion testing.

Key Factors for Dye Ingress Testing

1. The type of product that is in the container will determine  the dye that will be selected.
2. The fill volume of the container will determine the  amount of dye added for controls.
3. If the product is lyophilized, the volume that it  will need to be reconstituted to determine the dye amount added for controls.
4. The type of container closure being tested to determine  vacuum pressure ranges and total volume  required for submerging of the containers.
5. The type of dye selected for the tests must exhibit a  strong absorbance over a region of wavelengths and  must also be compatible with the sample matrix.  Most dyes are prepared in water, although adjustments  to the dye penetration can be made during the  development process. Brilliant Green and Methylene  Blue are two dyes that we consistently use.

Key Factors for Microbial Immersion Testing

1. The type and size of the container will determine the  immersion approach.
2. The media fill can determine if dye ingress is more  appropriate than microbial immersion.
3. The challenge organism selection can be influenced  by client preference or product formulation.
4. Immersion conditions under vacuum or static are  determined by container type or delivery system.

Key Factors for Microbial Aerosol Challenge Testing

1. The type and size of the container will determine  the size and internal volume of the air-tight testchamber and the Bacillus spores aerosolization  system and design.
2. The media fill can determine a customizer appropriate  worst case scenario approach.
3. The Bacillus spp. Selection, the aerosol density  and the exposure time can be influenced by client  preference
4. Bacillus spores aerosol exposure conditions are  controlled via a thermostated spore delivery system at 60°C in order to maintain spores dry but  viable.
5. Temperature and RH are monitored in the test  chamber and microbial challenge controls are performed.
6. An engineering run is always preliminary performed  and the system is fully validated before proceeding  with the main study.