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Cold chain: difference between revisions

Diff·revision 38 → 39·21:07, 5 Jan 2025

Difference between revision 38 and revision 39 of Cold chain. 6 lines changed; the page grew by 918 bytes.

Revision 38 — 16:45, 27 Dec 2024
SupplyWatchSuri (talk)
rm unsourced claim per PP:V
16,678 bytes ±0		Revision 39 — 21:07, 5 Jan 2025
GastroparesisGwen (talk)
link to the policy rather than restating it
17,596 bytes +918
96The first term is smaller than the second by a factor of e<sup>−3.357</sup>, or 0.0349, so it contributes almost nothing. Their mean is e<sup>−32.9869</sup> × 0.5174, and96The first term is smaller than the second by a factor of e<sup>−3.357</sup>, or 0.0349, so it contributes almost nothing. Their mean is e<sup>−32.9869</sup> × 0.5174, and
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+98{{math|T_{MKT} = 10000 ÷ (32.9869 + 0.6590) = 10000 ÷ 33.6459 = 297.21 K = 24.1 °C}}
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98== Packaging and qualification ==100== Packaging and qualification ==
99Between 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.101Between 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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105; 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}}107; 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}}
106108
+109Qualification is performed against standardised ambient profiles representing summer and winter conditions and including the transitions typical of air freight. ISTA Procedure 7D provides temperature test profiles for transport packaging, and ASTM D3103 gives a method for determining the thermal insulation quality of a package. Qualification establishes a duration — the time for which the package holds the payload within specification under the profile — and that duration is a property of the whole system, not of the insulation alone.{{r|ista7d,astm_d3103}}
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107=== Phase-change materials ===111=== Phase-change materials ===
108Water ice melts at 0 °C and therefore holds a payload close to that temperature while any ice remains — well below the 2 °C lower bound of the cold range, and a recognised cause of freezing excursions in 2–8 °C distribution. Phase-change materials are formulated to melt at a temperature inside the target range, commonly around 5 °C for refrigerated shipments and around 22 °C for controlled-room-temperature shipments, so that the latent heat of the transition buffers the payload at a temperature that is itself compliant.{{r|pda_tr39}}112Water ice melts at 0 °C and therefore holds a payload close to that temperature while any ice remains — well below the 2 °C lower bound of the cold range, and a recognised cause of freezing excursions in 2–8 °C distribution. Phase-change materials are formulated to melt at a temperature inside the target range, commonly around 5 °C for refrigerated shipments and around 22 °C for controlled-room-temperature shipments, so that the latent heat of the transition buffers the payload at a temperature that is itself compliant.{{r|pda_tr39}}
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123<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>127<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>
124<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>128<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>
+129<ref name="ista7d">International Safe Transit Association. ''ISTA Procedure 7D: Temperature Test for Transport Packaging''.</ref>
+130<ref name="astm_d3103">ASTM D3103, ''Standard Test Method for Thermal Insulation Quality of Packages''. ASTM International.</ref>
125<ref name="ich_q1a">International Council for Harmonisation, ''Q1A(R2): Stability Testing of New Drug Substances and Products'' (2003).</ref>131<ref name="ich_q1a">International Council for Harmonisation, ''Q1A(R2): Stability Testing of New Drug Substances and Products'' (2003).</ref>
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