Vial: difference between revisions
Diff·revision 13 → 14·05:15, 13 Jan 2025
Difference between revision 13 and revision 14 of Vial. 2 lines changed; the page grew by 509 bytes.
| Revision 13 — 05:27, 21 Dec 2024 GlossaryGaspar (talk) state the difference between a validated shipper and an insulated box 15,543 bytes +2,361 | Revision 14 — 05:15, 13 Jan 2025 ResinRhoswen (talk) add the data-logger point: an unlogged shipment has no excursion record 16,052 bytes +509 | ||
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| 104 | Closures for freeze-drying are a distinct type, specified in ISO 8362-5. Their skirt geometry permits the stopper to be seated partially, resting on lugs so that vapour can escape during drying, and then pressed fully home by the dryer shelves at the end of the cycle while the chamber is still evacuated or backfilled with nitrogen. The headspace composition of a lyophilised vial is therefore determined by the freeze-dryer, not by the filling room.{{r|iso8362_5}} | 104 | Closures for freeze-drying are a distinct type, specified in ISO 8362-5. Their skirt geometry permits the stopper to be seated partially, resting on lugs so that vapour can escape during drying, and then pressed fully home by the dryer shelves at the end of the cycle while the chamber is still evacuated or backfilled with nitrogen. The headspace composition of a lyophilised vial is therefore determined by the freeze-dryer, not by the filling room.{{r|iso8362_5}} |
| 105 | 105 | ||
| + | 106 | USP <381> sets the compendial requirements for elastomeric closures, including biological reactivity, physicochemical tests on aqueous extracts, self-sealing and fragmentation. The self-sealing test requires that a defined number of penetrations produce no leakage; the fragmentation test limits the number of visible elastomer fragments released into a liquid across a specified number of penetrations. The European Pharmacopoeia general chapter 3.2.9 imposes closely comparable tests.{{r|usp381,pheur329}} | |
| + | 107 | ||
| 106 | === Coring and fragmentation === | 108 | === Coring and fragmentation === |
| 107 | ''Coring'' is the excision of a plug or fragment of elastomer by a needle passing through the closure. It occurs when the needle cuts rather than parts the elastomer, and its likelihood rises with needle diameter, with a blunt or damaged bevel, with penetration perpendicular to the surface rather than at an angle, and with repeated penetration through the same point.{{r|usp381}} | 109 | ''Coring'' is the excision of a plug or fragment of elastomer by a needle passing through the closure. It occurs when the needle cuts rather than parts the elastomer, and its likelihood rises with needle diameter, with a blunt or damaged bevel, with penetration perpendicular to the surface rather than at an angle, and with repeated penetration through the same point.{{r|usp381}} |