LimsPulse
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
LEARN & PRACTICE

Test your Leak tester knowledge

Multiple-choice questions

Pick an answer to see whether you are right and why.

  1. Q1. Which dye is commonly used in the blister pack leak test?

    basic
  2. Q2. In a dye ingress test, the dye enters a leaking pack mainly when:

    basic
  3. Q3. Which of these is a deterministic leak test method?

    intermediate
  4. Q4. In vacuum decay testing, a leaking container shows:

    intermediate
  5. Q5. What is a positive control in container closure integrity testing?

    intermediate
  6. Q6. Which USP chapter covers package integrity evaluation of sterile products?

    advanced

Viva questions

Think of your answer first, then open it to compare.

  1. 1. Why are deterministic methods preferred over probabilistic ones?

    Deterministic methods measure a physical event with an objective, quantitative result and known detection limit, so they are more reliable and repeatable. Probabilistic methods depend on chance and on visual inspection and can miss small leaks.

  2. 2. Why should containers be dry before vacuum decay testing?

    Liquid on the outside evaporates under vacuum and raises the chamber pressure, which looks like a leak and gives false failures.

  3. 3. What is the maximum allowable leakage limit?

    It is the largest leak a container can have without putting product quality or sterility at risk. The chosen test method must be shown to detect leaks at or below this size.

In LimsPulse · Calibration Management

Keep every Leak tester in control: usage logs, calibration and maintenance schedules, and automatic blocking of overdue instruments.

See how