Vial: difference between revisions
Diff·revision 22 → 23·10:48, 12 Nov 2024
Difference between revision 22 and revision 23 of Vial. 3 lines changed; the page grew by 618 bytes.
| Revision 22 — 20:09, 7 Nov 2024 RepackRadek (talk) expand §Elastomeric closures 11,177 bytes ±0 | Revision 23 — 10:48, 12 Nov 2024 RepackRadek (talk) add {{refimprove}}11,795 bytes +618 | ||
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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]].}} | |
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| 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}} |
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| 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}} | 79 | 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}} |
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| + | 81 | 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}} | |
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| 80 | == References == | 83 | == References == |