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
CALIBRATION

Leak tester calibration procedures

Leak tester has no instrument calibration of its own in most labs. Its performance is controlled through qualification (below) and the system suitability or acceptance checks of each test that uses it.

QUALIFICATION

Instrument qualification (DQ · IQ · OQ · PQ)

  1. 01

    DQ — Design qualification

    Defines container types, sensitivity needed (detection limit), vacuum range and data integrity needs.

  2. 02

    IQ — Installation qualification

    Checks installation, utilities, software and calibration certificates.

  3. 03

    OQ — Operational qualification

    Verifies vacuum level, gauge accuracy, timer and (for vacuum decay) transducer response.

  4. 04

    PQ — Performance qualification

    Shows the test reliably detects positive controls and passes good containers for each product.

In LimsPulse · Calibration Management

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

See how