Cold chain: difference between revisions
Diff·revision 33 → 34·01:33, 29 Nov 2024
Difference between revision 33 and revision 34 of Cold chain. 9 lines changed; the page grew by 239 bytes.
| Revision 33 — 14:48, 23 Nov 2024 CiteBot (talk) bot: repair redlinked category 15,284 bytes +1,076 | Revision 34 — 01:33, 29 Nov 2024 NavboxNiko (talk) fix significant figures — source gives fewer 15,523 bytes +239 | ||
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| 92 | A worked case shows why the statistic is used. Consider a warehouse that spends 12 hours of each day at 2 °C and 12 hours at 30 °C — an unrealistically extreme cycle, chosen to make the arithmetic legible. The arithmetic mean is 16.0 °C. Converting to kelvin, 275.15 K and 303.15 K: | 92 | A worked case shows why the statistic is used. Consider a warehouse that spends 12 hours of each day at 2 °C and 12 hours at 30 °C — an unrealistically extreme cycle, chosen to make the arithmetic legible. The arithmetic mean is 16.0 °C. Converting to kelvin, 275.15 K and 303.15 K: |
| 93 | 93 | ||
| + | 94 | {{math|e^{−10000/275.15} = e^{−36.3438}}} and {{math|e^{−10000/303.15} = e^{−32.9869}}} | |
| + | 95 | ||
| 94 | == Packaging and qualification == | 96 | == Packaging and qualification == |
| 95 | Between controlled environments, the product travels inside a package that must maintain its internal temperature without external power. The performance of such a passive shipper is a designed property, qualified against defined ambient profiles, and it is specific to a payload. | 97 | Between controlled environments, the product travels inside a package that must maintain its internal temperature without external power. The performance of such a passive shipper is a designed property, qualified against defined ambient profiles, and it is specific to a payload. |
| ⋮ | ⋮ | ||
| 115 | <ref name="pda_tr39">Parenteral Drug Association. ''Technical Report No. 39: Guidance for Temperature-Controlled Medicinal Products — Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment''. Revised edition.</ref> | 117 | <ref name="pda_tr39">Parenteral Drug Association. ''Technical Report No. 39: Guidance for Temperature-Controlled Medicinal Products — Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment''. Revised edition.</ref> |
| 116 | <ref name="ich_q1a">International Council for Harmonisation, ''Q1A(R2): Stability Testing of New Drug Substances and Products'' (2003).</ref> | 118 | <ref name="ich_q1a">International Council for Harmonisation, ''Q1A(R2): Stability Testing of New Drug Substances and Products'' (2003).</ref> |
| + | 119 | ||
| + | 120 | == See also == | |
| + | 121 | * [[Temperature excursion]] | |
| + | 122 | * [[Cold-chain freight]] | |
| + | 123 | * [[Peptide stability table]] | |
| + | 124 | * [[Lyophilisation]] | |
| + | 125 | * [[Beyond-use date]] | |
| 117 | 126 | ||
| 118 | {{DEFAULTSORT:Cold chain}} | 127 | {{DEFAULTSORT:Cold chain}} |