Vial: difference between revisions
Diff·revision 28 → 29·19:04, 29 Dec 2024
Difference between revision 28 and revision 29 of Vial. 4 lines changed; the page grew by 1,045 bytes.
| Revision 28 — 18:59, 21 Dec 2024 SupplyWatchSuri (talk) ce, tighten prose 14,498 bytes +160 | Revision 29 — 19:04, 29 Dec 2024 SPPS_Sorrel (talk) split overlong sentence 15,543 bytes +1,045 | ||
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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 A vial labelled 2.0 mL and filled to 2.15 mL is withdrawn with a syringe of 0.07 mL [[Syringe dead space|dead space]]; the withdrawable volume is reduced by the dead space and by whatever the vial geometry traps at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. |
| ⋮ | ⋮ | ||
| 115 | <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> |
| 116 | <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> | |
| 117 | <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> |
| 118 | <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> |