ISO 13485 · Medium · 12 min lesson

Validating a pouch sealer end to end, and auditing clause 7.5.6

ISO 13485:2016 clauses 7.5.6, 7.5.7, 4.1.6 and 7.6; GHTF SG3 N99-10 sections 3 to 6

What you will learn

Follow a pouch sealer validation from the plan through IQ, OQ, PQ and the final report with realistic protocol and report excerpts.
Audit clause 7.5.6 as an internal auditor: trace a validation file, recognise the typical findings and write a sound nonconformity.
Place production software validation (clauses 4.1.6, 7.5.6, 7.6) and sterilisation validation (clause 7.5.7, ISO 11135 and 11137) in the validation system.

Key takeaways

Seal integrity cannot be fully verified afterwards, so the sealing process is validated (GHTF 3.1 and 3.2; clauses 7.5.6 and 7.5.7).
The plan, IQ, OQ, PQ and report each carry criteria set in advance; the OQ finds the window and the PQ proves routine production.
A passing IQ needs calibrated equipment (clause 7.6); a failing OQ condition is information that narrows the window.
Audit by tracing: process list, validation file, working instruction, change log and monitoring data.
Software is validated in proportion to risk (clauses 4.1.6, 7.5.6, 7.6); sterilisation is a separate validation under clause 7.5.7.

Free practice question

IQ-022 report, Orion RS-120 (fictional): 'Item 5 Calibration certificate: to follow - Pass. Item 9.2.3 Heater set to 190 C: display 190, reference probe 193.5 (criterion plus or minus 2 C) - Pass. Deviations: none. Conclusion: installation successful.' OQ is planned for Monday.

What should the reviewer do?

Reject the IQ conclusion: raise a deviation, calibrate and re-verify the controller before OQ starts.

Correct. Clause 7.6 requires calibrated equipment before use and GHTF section 5.3 lists calibration as an IQ topic; 3.5 C is outside the stated criterion.

Approve the IQ and let OQ start; the certificate can be added later.

Not quite. OQ data taken with an uncalibrated reference cannot be defended, and clause 7.6 requires calibration or verification before the equipment is used.

Approve the IQ, but start OQ only after the final report is written.

Not quite. Writing the report first does not fix the open calibration and criterion failure; GHTF section 5.3 needs the IQ items to pass before the next phase.

Change the criterion to plus or minus 4 C so that the item passes.

Not quite. Changing a criterion after seeing the result defeats objective evidence under clause 7.5.6 c and GHTF section 5.2, which want criteria fixed in advance.

Key terms

installation qualification: Objective evidence that equipment and utilities are installed to the approved specification and supplier recommendations (GHTF 2.1).
sterile barrier system: The minimum package that prevents ingress of microorganisms and allows aseptic presentation of the sterile contents.
worst case: The combination of parameter limits most likely to produce failed product, challenged in the OQ (GHTF 5.4).
tolerance bound: A limit calculated from the mean, SD and a factor k, so that a stated share of product is inside with stated confidence.
Cpk: Capability index using the nearer specification limit and three standard deviations; valid only for a stable process.
deviation: A departure from the protocol or criteria that is recorded, investigated and concluded on (GHTF 5.2).
master validation plan: The plan listing processes, approach, team and schedule for validation (GHTF section 8).
ISO 11135: Standard for the development, validation and routine control of ethylene oxide sterilisation processes.

Official sources

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The full lesson has narrated slides, more scenario questions with explained answers and a simulation.

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Illustrative example. Educational only, not legal advice.