In the pharmaceutical industry, packaging is the final barrier between the drug and the environment. If a blister pack, strip, or sachet has a microscopic leak, moisture and oxygen can enter, leading to chemical degradation, physical changes, or microbial contamination.
Why Leak Testing is Mandatory
A compromised package seal can cause:
- Chemical Degradation: Reducing API potency
- Physical Changes: Softening of tablets or clumping of powders
- Microbial Contamination: Compromising product safety
The Vacuum Decay Method
The most common and effective method for testing flexible packaging:
- Preparation: Samples placed in a desiccator jar filled with colored dye solution (usually Methylene Blue)
- Vacuum Application: The Leak Test Apparatus creates controlled vacuum inside the jar
- Pressure Differential: If there is a hole, the air inside is sucked out
- Observation: When vacuum is released, dye solution is drawn into faulty packages
- Inspection: Blue staining indicates a failed seal
Features of the RLT-1 Leak Test Apparatus
- Microprocessor Control: Ensures exact vacuum levels are reached and maintained
- Digital Display: Real-time monitoring of vacuum pressure and hold time
- Robust Desiccator: High-quality polycarbonate jars, easy to clean
- Programmable Methods: Store multiple testing protocols for different product lines
The RLT-1 offers an economical, fully calibrated solution for ensuring integrity of various packaging types.