Vial: difference between revisions
Diff·revision 19 → 20·14:07, 8 May 2025
Difference between revision 19 and revision 20 of Vial. 2 lines changed; the page grew by 506 bytes.
| Revision 19 — 08:32, 16 Apr 2025 DrTitration (talk) expand §Sealing and capping 19,236 bytes +957 | Revision 20 — 14:07, 8 May 2025 HOMA_Hettie (talk) add the stopper material, since it affects moisture ingress 19,742 bytes +506 | ||
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| 127 | Deterministic methods measure a physical quantity related to leakage, give quantitative results, and are reproducible: helium mass-spectrometric leak detection, vacuum decay, pressure decay, laser-based headspace analysis, and high-voltage leak detection. Probabilistic methods depend on a chain of stochastic events and give a pass or fail: microbial immersion challenge, dye ingress, and bubble tests. The chapter's position is that deterministic methods are preferred wherever available, and that probabilistic methods are appropriate mainly as qualitative confirmation.{{r|usp1207,kirsch1997}} | 127 | Deterministic methods measure a physical quantity related to leakage, give quantitative results, and are reproducible: helium mass-spectrometric leak detection, vacuum decay, pressure decay, laser-based headspace analysis, and high-voltage leak detection. Probabilistic methods depend on a chain of stochastic events and give a pass or fail: microbial immersion challenge, dye ingress, and bubble tests. The chapter's position is that deterministic methods are preferred wherever available, and that probabilistic methods are appropriate mainly as qualitative confirmation.{{r|usp1207,kirsch1997}} |
| 128 | 128 | ||
| + | 129 | The chapter also frames integrity in terms of a ''maximum allowable leakage limit'' — the largest leak that can be tolerated without compromising the product — which is to be established for the specific product rather than assumed. For microbial ingress, the leak size below which passage becomes improbable has been studied experimentally, and the frequently cited threshold of the order of a few micrometres derives from that work rather than from a compendial requirement.{{r|usp1207,kirsch1997}} | |
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| 129 | == References == | 131 | == References == |
| 130 | {{reflist}} | 132 | {{reflist}} |