Vacuum Decay Leak Test Log

Inspection log for recording non-destructive vacuum decay leak test results for package integrity verification in accordance with ASTM F2338.

Inspection Identification

• Product, lot, and sample identification recorded
  Record the product name, lot/batch number, sample ID, and any packaging configuration identifiers.
• Inspection date and time recorded
  Capture the date and time the vacuum decay leak test was performed.
• Inspector name and qualification recorded
  Record the inspector or operator performing the test and their qualification or authorization status.
• Test method identified as ASTM F2338 vacuum decay
  Confirm the test is being performed as a non-destructive vacuum decay leak test aligned to ASTM F2338.

Test Equipment and Calibration

• Vacuum decay test instrument identified
  Record the instrument model, serial number, and chamber or fixture identification used for the test.
• Pressure/vacuum sensor calibration current
  Confirm calibration is current for the test instrument and any connected pressure or vacuum sensors.
• Vacuum chamber and seals clean, intact, and free of visible damage
  Verify the chamber, gaskets, O-rings, fittings, and seals are clean and in serviceable condition before testing.
• Reference standard or challenge sample available when required by SOP
  Confirm any required reference standard, positive control, or challenge sample is available and identified per site procedure.

Test Setup and Parameters

• Sample count tested recorded
  Enter the number of packages or samples tested in this log entry.
• Vacuum setpoint recorded
  Record the target vacuum level used for the test.
• Hold time recorded
  Record the vacuum hold duration used for the test.
• Test chamber temperature recorded
  Record the chamber or ambient temperature at the time of testing if required by the method or SOP.
• Acceptance criteria documented before testing
  Record the pass/fail criteria, including allowable leak threshold or instrument decision limit used for this test run.

Vacuum Decay Results

• Vacuum decay result meets acceptance criteria
  Confirm the measured vacuum decay result is within the documented acceptance criteria.
• Measured vacuum decay value recorded
  Enter the measured decay value observed during the test.
• Leak indication observed
  Indicate whether the instrument or operator observed evidence of a leak, unstable pressure trend, or abnormal decay pattern.
• Test run repeatability acceptable
  Confirm repeat runs, if performed, were consistent with the original result and within site-defined repeatability limits.

Defects, Disposition, and Sign-Off

• Non-conformance documented for failed or suspect samples
  Record whether any failed, borderline, or suspect samples were identified and routed to the appropriate disposition process.
• Corrective action or investigation reference recorded
  Enter the CAPA, deviation, investigation, or hold reference number when a failure or non-conformance occurs.
• Inspector signature
  Signature of the person completing the log entry.
• Supervisor or QA review completed
  Confirm review and approval by supervisor, QA, or designated reviewer when required by site procedure.