Seal Integrity Test
BACKGROUND:
The packaging of pharmaceutical products needs to be checked for the integrity of its seal after sterilisation. Any packaging with a compromised seal due to either breakage or damage can be detected by demonstration of either Microbial growth or Dye Intrusion.
PRINCIPLE OF TESTS:
There are several tests that can be performed to determine seal integrity. In Eurofins | ams, seal integrity testing or container closure integrity testing is performed via the two methods shown below.
Microbial Ingress Method
Microbial Ingress method involves immersing media filled package units into a liquid suspension of microorganisms (105-106cfu/mL) for a specified period of time and then removing, rinsing, incubating and examining the units for microbial growth. Selection of challenge organisms is based on the size and motility of the organism. Recommended organisms include
- Escherichia coli
- Clostridium sporogenes
- Staphylococcus epidermidis
- Pseudomonas aeruginosa
- Searratia marcesans
- Brevundimonas diminuta
Dye Intrusion Method
Dye Intrusion method involves immersing sample containers in a dye solution under pressure for a specified period of time and observing the intrusion of dye in the sample containers. Sample containers should be filled with water for this study.
SAMPLE REQUIREMENTS:
Depending on the packaging of the product, this needs to be discussed with our staff. Contact us to discuss further.
