Vial: difference between revisions
Diff·revision 20 → 21·07:27, 29 May 2025
Difference between revision 20 and revision 21 of Vial. 7 lines changed; the page grew by 531 bytes.
| Revision 20 — 14:07, 8 May 2025 HOMA_Hettie (talk) add the stopper material, since it affects moisture ingress 19,742 bytes +506 | Revision 21 — 07:27, 29 May 2025 ITT_Imelda (talk) state that overlay gas is used and name it 20,273 bytes +531 | ||
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| 122 | Two consequences bear on handling. Once a flip-off button is removed, the exposed stopper surface is no longer protected, and its disinfection before each penetration is the compendially expected practice for multiple-dose containers. And the crimp is not intended to be removed and replaced; a vial whose ferrule shows evidence of having been decapped and recrimped has an unknown seal history, which is a recognised indicator in the examination of suspected [[Repackaging|repackaged]] or [[Counterfeit peptide|counterfeit]] material.{{r|usp1207}} | 122 | Two consequences bear on handling. Once a flip-off button is removed, the exposed stopper surface is no longer protected, and its disinfection before each penetration is the compendially expected practice for multiple-dose containers. And the crimp is not intended to be removed and replaced; a vial whose ferrule shows evidence of having been decapped and recrimped has an unknown seal history, which is a recognised indicator in the examination of suspected [[Repackaging|repackaged]] or [[Counterfeit peptide|counterfeit]] material.{{r|usp1207}} |
| 123 | 123 | ||
| + | 124 | {{figure|coa-sheet|A certificate of analysis identifies the lot but not the container. Where a lot number appears only on a peelable label, the link between document and vial is weak.}} | |
| + | 125 | ||
| 124 | == Container closure integrity == | 126 | == Container closure integrity == |
| 125 | Integrity is the ability of the container closure system to prevent ingress of micro-organisms and, where required, to maintain headspace composition. USP <1207> is the governing informational chapter and it reorganised thinking on the subject by classifying methods as ''deterministic'' or ''probabilistic''.{{r|usp1207}} | 127 | Integrity is the ability of the container closure system to prevent ingress of micro-organisms and, where required, to maintain headspace composition. USP <1207> is the governing informational chapter and it reorganised thinking on the subject by classifying methods as ''deterministic'' or ''probabilistic''.{{r|usp1207}} |
| ⋮ | ⋮ | ||
| 146 | <ref name="kirsch1997">Kirsch LE, Nguyen L, Moeckly CS. "Pharmaceutical container/closure integrity I: mass spectrometry-based helium leak rate detection for rubber-stoppered glass vials." ''PDA Journal of Pharmaceutical Science and Technology'' 51(5):187–194 (1997).</ref> | 148 | <ref name="kirsch1997">Kirsch LE, Nguyen L, Moeckly CS. "Pharmaceutical container/closure integrity I: mass spectrometry-based helium leak rate detection for rubber-stoppered glass vials." ''PDA Journal of Pharmaceutical Science and Technology'' 51(5):187–194 (1997).</ref> |
| 147 | 149 | ||
| + | 150 | == Further reading == | |
| + | 151 | * Sacha GA, Saffell-Clemmer W, Abram K, Akers MJ. "Practical fundamentals of glass, rubber, and plastic sterile packaging systems." ''Pharmaceutical Development and Technology'' 15(1):6–34 (2010). | |
| + | 152 | * Guazzo DM. "Container closure integrity testing" in ''Sterile Product Development'', Springer (2013). | |
| + | 153 | ||
| 148 | == See also == | 154 | == See also == |
| 149 | * [[Multi-dose vial]] | 155 | * [[Multi-dose vial]] |
| ⋮ | ⋮ | ||
| 153 | * [[Reconstitution of lyophilised peptides]] | 159 | * [[Reconstitution of lyophilised peptides]] |
| 154 | * [[Underfilling]] | 160 | * [[Underfilling]] |
| + | 161 | * [[Repackaging]] | |
| 155 | 162 | ||
| 156 | {{DEFAULTSORT:Vial}} | 163 | {{DEFAULTSORT:Vial}} |