Vial: difference between revisions
Diff·revision 12 → 13·05:27, 21 Dec 2024
Difference between revision 12 and revision 13 of Vial. 16 lines changed; the page grew by 2,361 bytes.
| Revision 12 — 15:09, 2 Dec 2024 PrepHPLC_Pia (talk) expand §Vials in unregulated distribution 13,182 bytes +303 | 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 | ||
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| 84 | | 50 mL or more | 2% | 3% | | 84 | | 50 mL or more | 2% | 3% | |
| 85 | 85 | ||
| + | 86 | Figures are those recommended in the general chapter for single-dose containers.{{r|usp697,usp1151}} A worked case shows how thin the margin is in practice. A vial labelled 2.0 mL and filled to 2.15 mL is withdrawn with a syringe of 0.07 mL [[Syringe dead space|dead space]]; the withdrawable volume is reduced by the dead space and by whatever the vial geometry traps at the base, so the nominal 0.15 mL excess is very largely consumed by the device. For a reconstituted research peptide, where the operator chooses the diluent volume, the same arithmetic governs how much of the nominal fill is actually obtainable, and it is the reason a nominal ten-dose vial commonly yields fewer.{{r|usp697}} | |
| + | 87 | ||
| 86 | == Elastomeric closures == | 88 | == Elastomeric closures == |
| 87 | 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. | 89 | 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. |
| ⋮ | ⋮ | ||
| 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}} | 102 | 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}} |
| 101 | 103 | ||
| + | 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 | ||
| 102 | === Coring and fragmentation === | 106 | === Coring and fragmentation === |
| 103 | ''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}} | 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}} |
| ⋮ | ⋮ | ||
| 105 | 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]]. | 109 | 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]]. |
| 106 | 110 | ||
| + | 111 | 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}} | |
| + | 112 | ||
| 107 | == References == | 113 | == References == |
| 108 | {{reflist}} | 114 | {{reflist}} |
| ⋮ | ⋮ | ||
| 111 | <ref name="usp381">United States Pharmacopeia, General Chapter <381>, "Elastomeric Closures for Injections". USP–NF, current revision.</ref> | 117 | <ref name="usp381">United States Pharmacopeia, General Chapter <381>, "Elastomeric Closures for Injections". USP–NF, current revision.</ref> |
| 112 | <ref name="usp1381">United States Pharmacopeia, General Chapter <1381>, "Assessment of Elastomeric Components Used in Injectable Pharmaceutical Product Packaging/Delivery Systems" (informational). USP–NF, current revision.</ref> | 118 | <ref name="usp1381">United States Pharmacopeia, General Chapter <1381>, "Assessment of Elastomeric Components Used in Injectable Pharmaceutical Product Packaging/Delivery Systems" (informational). USP–NF, current revision.</ref> |
| + | 119 | <ref name="usp697">United States Pharmacopeia, General Chapter <697>, "Container Content for Injections". USP–NF, current revision.</ref> | |
| + | 120 | <ref name="usp1151">United States Pharmacopeia, General Chapter <1151>, "Pharmaceutical Dosage Forms" (informational), including recommended excess volumes for injections. USP–NF, current revision.</ref> | |
| 113 | <ref name="usp1207">United States Pharmacopeia, General Chapter <1207>, "Package Integrity Evaluation — Sterile Products" (informational), with subchapters <1207.1> to <1207.3>. USP–NF, current revision.</ref> | 121 | <ref name="usp1207">United States Pharmacopeia, General Chapter <1207>, "Package Integrity Evaluation — Sterile Products" (informational), with subchapters <1207.1> to <1207.3>. USP–NF, current revision.</ref> |
| 114 | <ref name="iso8362_1">ISO 8362-1:2018, ''Injection containers and accessories — Part 1: Injection vials made of glass tubing'', read with ISO 8362-4:2011, ''Part 4: Injection vials made of moulded glass''. International Organization for Standardization.</ref> | 122 | <ref name="iso8362_1">ISO 8362-1:2018, ''Injection containers and accessories — Part 1: Injection vials made of glass tubing'', read with ISO 8362-4:2011, ''Part 4: Injection vials made of moulded glass''. International Organization for Standardization.</ref> |
| 115 | <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> | 123 | <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> |
| 116 | <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> | 124 | <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> |
| + | 125 | <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> | |
| 117 | <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> | 126 | <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> |
| 118 | <ref name="fda2011">US Food and Drug Administration. "Advisory to Drug Manufacturers: Formation of Glass Lamellae in Certain Injectable Drugs" (March 2011).</ref> | 127 | <ref name="fda2011">US Food and Drug Administration. "Advisory to Drug Manufacturers: Formation of Glass Lamellae in Certain Injectable Drugs" (March 2011).</ref> |
| + | 128 | ||
| + | 129 | == See also == | |
| + | 130 | * [[Multi-dose vial]] | |
| + | 131 | * [[Vial filling and stoppering]] | |
| + | 132 | * [[Lyophilisation]] | |
| + | 133 | * [[Beyond-use date]] | |
| + | 134 | * [[Reconstitution of lyophilised peptides]] | |
| 119 | 135 | ||
| 120 | {{DEFAULTSORT:Vial}} | 136 | {{DEFAULTSORT:Vial}} |