Vial: difference between revisions
Diff·revision 10 → 11·21:53, 18 Nov 2024
Difference between revision 10 and revision 11 of Vial. 19 lines changed; the page grew by 1,702 bytes.
| Revision 10 — 15:57, 3 Nov 2024 FmocFrancis (talk) state the residual-moisture target with the method it is measured by 11,177 bytes ±0 | Revision 11 — 21:53, 18 Nov 2024 RepackRadek (talk) add the collapse-temperature point, sourced 12,879 bytes +1,702 | ||
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| 14 | | Principal degradation mode = Inner-surface delamination | 14 | | Principal degradation mode = Inner-surface delamination |
| 15 | }} | 15 | }} |
| + | 16 | {{hatnote|For containers intended for repeated withdrawal, see [[Multi-dose vial]]. For the operations that fill and close them, see [[Vial filling and stoppering]].}} | |
| 16 | 17 | ||
| 17 | A '''vial''' is a small container, conventionally of glass, closed by an elastomeric stopper retained under a crimped metal ferrule. It is the standard primary package for injectable products and for [[Lyophilisation|lyophilised]] solids, including the great majority of peptides distributed for research use. The vial, its closure and its seal are treated in pharmaceutical practice as a single functional unit — the container closure system — because none of the three performs its function without the others.{{r|usp1207}} | 18 | A '''vial''' is a small container, conventionally of glass, closed by an elastomeric stopper retained under a crimped metal ferrule. It is the standard primary package for injectable products and for [[Lyophilisation|lyophilised]] solids, including the great majority of peptides distributed for research use. The vial, its closure and its seal are treated in pharmaceutical practice as a single functional unit — the container closure system — because none of the three performs its function without the others.{{r|usp1207}} |
| ⋮ | ⋮ | ||
| 64 | The label declaration for an injectable is the volume or mass withdrawable, and vials are therefore filled with a small excess. USP <697> requires that the volume obtainable be not less than the labelled volume, and USP <1151> gives recommended excess volumes for that purpose. | 65 | The label declaration for an injectable is the volume or mass withdrawable, and vials are therefore filled with a small excess. USP <697> requires that the volume obtainable be not less than the labelled volume, and USP <1151> gives recommended excess volumes for that purpose. |
| 65 | 66 | ||
| + | 67 | |+ Recommended excess volume, USP <1151> | |
| + | 68 | | !Labelled volume | Excess for mobile liquids | Excess for viscous liquids | | |
| + | 69 | |---|---|---| | |
| + | 70 | | 0.5 mL | 0.10 mL | 0.12 mL | | |
| + | 71 | | 1.0 mL | 0.10 mL | 0.15 mL | | |
| + | 72 | | 2.0 mL | 0.15 mL | 0.25 mL | | |
| + | 73 | | 5.0 mL | 0.30 mL | 0.50 mL | | |
| + | 74 | | 10 mL | 0.50 mL | 0.70 mL | | |
| + | 75 | | 20 mL | 0.60 mL | 0.90 mL | | |
| + | 76 | | 50 mL or more | 2% | 3% | | |
| + | 77 | ||
| 66 | == Elastomeric closures == | 78 | == Elastomeric closures == |
| 67 | The stopper performs three functions: it seals, it is penetrable by a needle and reseals afterwards, and it must not contribute leachables to the product. No single elastomer optimises all three, and formulation is a compromise. | 79 | The stopper performs three functions: it seals, it is penetrable by a needle and reseals afterwards, and it must not contribute leachables to the product. No single elastomer optimises all three, and formulation is a compromise. |
| ⋮ | ⋮ | ||
| 77 | 89 | ||
| 78 | Butyl elastomers dominate because their low permeability protects a lyophilised cake from moisture ingress and an oxygen-sensitive product from oxidation over a multi-year shelf life. A closure formulation is a mixture of elastomer, filler, curing system, pigment and lubricant, and the components other than the elastomer are frequently the source of the extractables that make a closure unsuitable for a particular product.{{r|usp381,usp1381}} | 90 | Butyl elastomers dominate because their low permeability protects a lyophilised cake from moisture ingress and an oxygen-sensitive product from oxidation over a multi-year shelf life. A closure formulation is a mixture of elastomer, filler, curing system, pigment and lubricant, and the components other than the elastomer are frequently the source of the extractables that make a closure unsuitable for a particular product.{{r|usp381,usp1381}} |
| + | 91 | ||
| + | 92 | 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}} | |
| + | 93 | ||
| + | 94 | === Coring and fragmentation === | |
| + | 95 | ''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}} | |
| + | 96 | ||
| + | 97 | 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]]. | |
| 79 | 98 | ||
| 80 | == References == | 99 | == References == |