Package integrity testing is critical for ensuring pharmaceutical products remain protected throughout their shelf life.
Why Package Integrity Matters
Product Protection
Packaging must protect against:
- Moisture ingress
- Oxygen exposure
- Microbial contamination
- Light degradation
Regulatory Requirements
Regulatory agencies require demonstration of package integrity for:
- Product registration
- Stability studies
- Batch release
Testing Methods
Vacuum Decay (Dye Test)
The most common method for flexible packaging:
- Samples placed in dye solution
- Vacuum applied
- Air exits through any leaks
- Vacuum released, dye enters faulty packages
- Visual inspection for dye penetration
Bubble Emission
Packages submerged and vacuum applied. Bubbles indicate leak location.
Pressure Decay
Sealed packages pressurized, pressure monitored for decay indicating leaks.
Visual Inspection
Examination for obvious defects:
- Seal integrity
- Punctures or tears
- Material defects
Equipment: RLT-1 Leak Test Apparatus
Features
- Microprocessor controlled vacuum
- Digital pressure display
- Programmable test parameters
- Robust desiccator construction
Applications
Testing of:
- Blister packs
- Strip packaging
- Sachets
- Pouches
Test Parameters
Vacuum Level
Typically -15 to -25 inches Hg depending on package type.
Hold Time
Duration under vacuum, usually 30-60 seconds.
Dye Selection
Methylene Blue commonly used for visibility.
Documentation
Records must include:
- Test parameters used
- Sample identification
- Results (pass/fail)
- Inspector signature