Dosage-form testing
Leak / Vacuum Tester
Checks that packs and containers are sealed, by pulling a vacuum around them and looking for dye ingress, bubbles or a rise in chamber pressure. Covers simple blister leak tests and deterministic vacuum-decay CCI testing.
- Pharmaceutical
- Medical devices
- Food packaging
- Nutraceutical
Follow your site SOP
This is a typical operating sequence for learning. Your instrument model and approved SOP take precedence.
STAGE 1
Before you start
- 1Check the gauge and tester are within calibration.
- 2For dye tests, prepare fresh methylene blue solution as per the SOP.
- 3For vacuum decay, select the validated recipe for the container type and run the positive and negative controls.
- Inspect the glass chamber for cracks before applying vacuum; a cracked vessel can implode.
STAGE 2
Dye ingress (blister) test
- 1Place the strips in the chamber and cover them with dye solution, using the hold-down plate.
- 2Close the lid and apply the set vacuum (as per SOP) for the set time.
- 3Release the vacuum slowly and leave the strips in the dye for the stated time.
- 4Remove, rinse and dry the strips, then open each pocket and check for blue dye.
STAGE 3
Vacuum decay test
- 1Place the container in the test chamber and close it.
- 2Start the cycle; the tester evacuates, stabilises and measures the pressure rise.
- 3Read the pass/fail result and record it.
- 4Re-run the positive control at the end of the session to show the system still detects leaks.
- Containers wet on the outside can give false failures; dry them first.
In LimsPulse · Calibration Management
Keep every Leak tester in control: usage logs, calibration and maintenance schedules, and automatic blocking of overdue instruments.