Container Closure Integrity or Seal Integrity Test
BACKGROUND:
The packaging of pharmaceutical products needs to be checked for the integrity of its container or its seal after sterilization. Any container or 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. For the full comprehensive range of testing provided by the Eurofins Biopharma Product Testing group, please click here.
Locally in Australia, Eurofins BPT Sydney can perform seal integrity or container closure integrity testing via the two methods shown below.
Microbial Ingress Method
Microbial Ingress method involves immersing media filled package units into a liquid suspension of microorganisms (10⁵-10⁶ cfu/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.
METHOD REFERENCE:
- ASTM D 4991-94: Standard Test Method for Leakage testing of Empty Rigid Containers by Vacuum, Method.
- ASTM F 1980- 07: Standard guide for accelerated aging of sterile barrier systems for medical devices
- USP <1207>
- PDA Technical Report 27
SAMPLE REQUIREMENTS:
Depending on the packaging of the product, this needs to be discussed with our staff. Contact us to discuss further.
TURNAROUND TIME:
Dye Intrusion Method - 21 Working Days (WD) including consecutive 7 Calendar Day incubations at 25°C and 35°C