Container closure integrity testing modernised
Ergopharm has modernised how it demonstrates container closure integrity for its sealed ampoules, moving from probabilistic dye-ingress testing towards deterministic methods.
Dye ingress is easy to run and hard to trust: it depends on the dye finding the defect, on the operator seeing the colour, and on a chain of conditions that are difficult to make reproducible. Deterministic methods measure a physical quantity instead, giving a numerical result with a defined detection limit.
“If you cannot state the smallest leak your test can find, you cannot state that the pack is tight.”
For flame-sealed glass ampoules, integrity is assured first by the sealing process itself — validated, monitored and 100% visually inspected — and confirmed by a deterministic method with positive controls at a known defect size.
The approach follows the thinking set out in USP general chapter <1207> on package integrity evaluation, which favours methods whose detection capability can be stated rather than inferred.
Key facts
- Moved from
- Probabilistic dye ingress
- Moved to
- Deterministic method with stated detection limit
- First line of assurance
- Validated sealing, 100% visual inspection
- Reference
- USP <1207>
This notice describes Ergopharm’s own packaging and processes and how they follow published standards; it does not assert a specific national marketing approval.