Vial: difference between revisions
Diff·revision 26 → 27·17:35, 14 Dec 2024
Difference between revision 26 and revision 27 of Vial. 12 lines changed; the page grew by 1,425 bytes.
| Revision 26 — 14:19, 5 Dec 2024 SPPS_Sorrel (talk) de-orphan 12,913 bytes ±0 | Revision 27 — 17:35, 14 Dec 2024 CategoryBot (talk) bot: update parent category chain 14,338 bytes +1,425 | ||
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| 14 | | Forming routes = Drawn from tubing; moulded | 14 | | Forming routes = Drawn from tubing; moulded |
| 15 | | Principal degradation mode = Inner-surface delamination | 15 | | Principal degradation mode = Inner-surface delamination |
| + | 16 | <!-- Applicable standards --> | |
| + | 17 | | Vials from glass tubing = ISO 8362-1 | |
| + | 18 | | Closures for injection vials = ISO 8362-2 | |
| + | 19 | | Freeze-drying closures = ISO 8362-5 | |
| + | 20 | | Elastomeric closures = USP <381> | |
| + | 21 | | Container closure integrity = USP <1207> | |
| + | 22 | | Inner-surface durability = USP <1660> | |
| 16 | }} | 23 | }} |
| 17 | {{hatnote|For containers intended for repeated withdrawal, see [[Multi-dose vial]]. For the operations that fill and close them, see [[Vial filling and stoppering]].}} | 24 | {{hatnote|For containers intended for repeated withdrawal, see [[Multi-dose vial]]. For the operations that fill and close them, see [[Vial filling and stoppering]].}} |
| ⋮ | ⋮ | ||
| 93 | Fluoropolymer lamination — a thin film of a fluorinated polymer applied to the product-contact face — is the standard mitigation. It reduces extractables and adsorptive loss of peptide onto the stopper surface without altering the bulk mechanical properties on which sealing and resealing depend. Silicone-oil lubrication of the outer surface aids machine handling but is itself an extractable and a source of subvisible particles.{{r|usp1381}} | 100 | Fluoropolymer lamination — a thin film of a fluorinated polymer applied to the product-contact face — is the standard mitigation. It reduces extractables and adsorptive loss of peptide onto the stopper surface without altering the bulk mechanical properties on which sealing and resealing depend. Silicone-oil lubrication of the outer surface aids machine handling but is itself an extractable and a source of subvisible particles.{{r|usp1381}} |
| 94 | 101 | ||
| + | 102 | 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}} | |
| + | 103 | ||
| 95 | === Coring and fragmentation === | 104 | === Coring and fragmentation === |
| 96 | ''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}} | 105 | ''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}} |
| ⋮ | ⋮ | ||
| 98 | The consequences are two. A fragment may be drawn into the syringe and injected, which is a particulate-contamination event; and the resulting channel may compromise the seal of a container intended for further withdrawals, which is a integrity event and matters chiefly for [[Multi-dose vial|multiple-dose containers]]. | 107 | The consequences are two. A fragment may be drawn into the syringe and injected, which is a particulate-contamination event; and the resulting channel may compromise the seal of a container intended for further withdrawals, which is a integrity event and matters chiefly for [[Multi-dose vial|multiple-dose containers]]. |
| 99 | 108 | ||
| + | 109 | Compendial fragmentation testing quantifies the propensity: a specified number of penetrations is made with a needle of specified gauge through closures on filled vials, the contents are filtered, and the visible fragments counted against a limit. Because the test is performed with a defined needle and technique, it characterises the closure rather than any particular pattern of use, and a closure that passes can still be cored by a blunt needle used repeatedly at one point.{{r|usp381,pheur329}} | |
| + | 110 | ||
| 100 | == References == | 111 | == References == |
| 101 | {{reflist}} | 112 | {{reflist}} |
| ⋮ | ⋮ | ||
| 108 | <ref name="iso8362_5">ISO 8362-5:2016, ''Injection containers and accessories — Part 5: Freeze drying closures for injection vials'', read with ISO 8362-6:2010, ''Part 6: Caps made of aluminium-plastics combinations for injection vials''. International Organization for Standardization.</ref> | 119 | <ref name="iso8362_5">ISO 8362-5:2016, ''Injection containers and accessories — Part 5: Freeze drying closures for injection vials'', read with ISO 8362-6:2010, ''Part 6: Caps made of aluminium-plastics combinations for injection vials''. International Organization for Standardization.</ref> |
| 109 | <ref name="pheur321">European Pharmacopoeia, general chapter 3.2.1, "Glass containers for pharmaceutical use", read with ISO 719 and ISO 720 hydrolytic resistance tests.</ref> | 120 | <ref name="pheur321">European Pharmacopoeia, general chapter 3.2.1, "Glass containers for pharmaceutical use", read with ISO 719 and ISO 720 hydrolytic resistance tests.</ref> |
| + | 121 | <ref name="pheur329">European Pharmacopoeia, general chapter 3.2.9, "Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders".</ref> | |
| 110 | <ref name="ennis2001">Ennis RD, Pritchard R, Nakamura C, et al. "Glass vials for small volume parenterals: influence of drug and manufacturing processes on glass delamination." ''Pharmaceutical Development and Technology'' 6(3):393–405 (2001).</ref> | 122 | <ref name="ennis2001">Ennis RD, Pritchard R, Nakamura C, et al. "Glass vials for small volume parenterals: influence of drug and manufacturing processes on glass delamination." ''Pharmaceutical Development and Technology'' 6(3):393–405 (2001).</ref> |
| 111 | <ref name="fda2011">US Food and Drug Administration. "Advisory to Drug Manufacturers: Formation of Glass Lamellae in Certain Injectable Drugs" (March 2011).</ref> | 123 | <ref name="fda2011">US Food and Drug Administration. "Advisory to Drug Manufacturers: Formation of Glass Lamellae in Certain Injectable Drugs" (March 2011).</ref> |