ISO 13485 · Expert · 13 min lesson

Packaging validation under ISO 11607-2: sealing, ageing, transport and integrity testing

ISO 11607-2:2019 and Amendment 1:2023 clause 5, ISO 11607-1 clause 7, ISO 13485:2016 clause 7.5.7, ASTM F88, F1929, F2096, F1980, D4169

What you will learn

Explain how IQ, OQ and PQ apply to forming, sealing and assembly processes under ISO 11607-2 and ISO 13485 clause 7.5.7.
Choose seal strength and integrity tests, sample sizes and acceptance criteria, and plan accelerated and real-time ageing and transport simulation.
Set up process monitoring and revalidation triggers, and recognise a weak packaging validation report.

ISO 11607-2 requires forming, sealing and assembly processes to be validated through IQ, OQ and PQ, with parameters monitored in routine production.
OQ challenges the parameter window at its limits; PQ shows reproducibility over several runs with representative product and criteria set in advance.
Seal strength (ASTM F88) and integrity tests (ASTM F1929, F2096, visual F1886) answer different questions and need validated methods and sample rationales.
Shelf life is supported by ageing then testing of sterilised packages; accelerated ageing (ASTM F1980) must be justified and confirmed by real-time ageing.
Transport simulation (for example ASTM D4169 or ISTA 3A) precedes integrity testing, and changes of parameters, materials or equipment trigger revalidation.

Marlow's PQ report states 'seals were acceptable' for a single run of 30 pouches at the nominal setting, checked visually.

What is the main weakness?

There is no weakness because seals were checked by a qualified person.

Not quite. A visual check cannot measure strength, so ISO 13485 clause 7.5.7 evidence is lacking.

The criteria are not measurable, the limits were not challenged and reproducibility over several runs was not shown.

Correct. Clause 5 of ISO 11607-2 expects predefined measurable criteria, OQ at the limits and PQ showing reproducibility.

The only weakness is the pouch colour.

Not quite. Pouch colour is irrelevant to the validation requirements of clause 5 of ISO 11607-2 on criteria and limits.

The weakness is that too many pouches were tested.

Not quite. Thirty pouches is not too many; the issue is measurability, limits and reproducibility under clause 5.

IQ, OQ, PQ: Installation, operational and performance qualification: the three stages of validating a forming, sealing or assembly process.
seal strength: The force needed to separate a seal, measured by a method such as ASTM F88, with acceptance limits set in advance.
seal integrity: Absence of channels or gaps in the barrier, tested by methods such as dye penetration (ASTM F1929) or bubble emission (ASTM F2096).
accelerated ageing: Holding packages at raised temperature for a shorter time to simulate shelf life, using a model such as that in ASTM F1980.
real-time ageing: Storing packages under labelled conditions for the full shelf life to confirm accelerated results.
worst case: The combination of parameters, materials and conditions most likely to cause failure, used to challenge the process.
distribution simulation: Laboratory exposure of packaged product to handling, vibration and shock, for example per ASTM D4169 or ISTA 3A.
sterile barrier system: The minimum package preventing microbial ingress and allowing aseptic presentation at the point of use.

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

Illustrative example. Educational only, not legal advice.