Cold chain: difference between revisions

Diff·revision 14 → 15·15:31, 20 Nov 2024

Difference between revision 14 and revision 15 of Cold chain. 19 lines changed; the page grew by 1,581 bytes.

Revision 14 — 19:22, 1 Nov 2024 CiteBot (talk) bot: normalise temperature formatting 13,942 bytes +2,489	Revision 15 — 15:31, 20 Nov 2024 eGFR_Esme (talk) add the crimp-seal step to the fill-and-finish description 15,523 bytes +1,581
14	\| Controlled room temperature = 20–25 °C; mean kinetic temperature not above 25 °C	14	\| Controlled room temperature = 20–25 °C; mean kinetic temperature not above 25 °C
15	\| Warm = 30–40 °C	15	\| Warm = 30–40 °C
+		16	<!-- Monitoring -->
+		17	\| Conventional logger accuracy expectation = ±0.5 °C across 2–8 °C
+		18	\| Typical logging interval = 1–15 minutes
+		19	\| Summary statistic for cumulative exposure = Mean kinetic temperature
+		20	\| Package qualification test methods = ISTA 7D; ASTM D3103
16	}}	21	}}
17	{{hatnote\|For departures from the conditions described here, see [[Temperature excursion]]. For the freight arrangements themselves, see [[Cold-chain freight]].}}	22	{{hatnote\|For departures from the conditions described here, see [[Temperature excursion]]. For the freight arrangements themselves, see [[Cold-chain freight]].}}
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87	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:
88		93
+		94	{{math\|e^{−10000/275.15} = e^{−36.3438}}} and {{math\|e^{−10000/303.15} = e^{−32.9869}}}
+		95
89	== Packaging and qualification ==	96	== Packaging and qualification ==
90	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.
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92	The components are an insulating shell, a coolant, and a payload space arranged so that the coolant neither contacts the product directly nor is separated from it by so much air that it cannot influence it.	99	The components are an insulating shell, a coolant, and a payload space arranged so that the coolant neither contacts the product directly nor is separated from it by so much air that it cannot influence it.
93		100
+		101	; Insulation : Expanded polystyrene, polyurethane and vacuum-insulated panels in ascending order of thermal performance, cost and weight. Vacuum panels achieve roughly an order of magnitude lower conductivity than expanded polystyrene of the same thickness.
+		102	; Coolant : Water ice, gel packs, phase-change materials formulated to melt at a chosen temperature, and dry ice for frozen shipments. Coolant mass and its conditioning before packing are as consequential as its identity.
+		103	; Payload arrangement : A qualified configuration specifies coolant placement, payload volume and the minimum and maximum payload for which the qualification holds. A shipper qualified for a full payload frequently fails when shipped part-full, because the reduced thermal mass follows the coolant more closely.{{r\|pda_tr39}}
+		104
94	== References ==	105	== References ==
95	{{reflist}}	106	{{reflist}}
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104	<ref name="lloyd2017">Lloyd J, Cheyne J. "The origins of the vaccine cold chain and a glimpse of the future." ''Vaccine'' 35(17):2115–2120 (2017).</ref>	115	<ref name="lloyd2017">Lloyd J, Cheyne J. "The origins of the vaccine cold chain and a glimpse of the future." ''Vaccine'' 35(17):2115–2120 (2017).</ref>
105	<ref name="eugdp2013">European Commission. ''Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use'' (2013/C 343/01). Official Journal of the European Union.</ref>	116	<ref name="eugdp2013">European Commission. ''Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use'' (2013/C 343/01). Official Journal of the European Union.</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>
106	<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]]
107		126
108	{{DEFAULTSORT:Cold chain}}	127	{{DEFAULTSORT:Cold chain}}