仓库冷库冰箱等验证模拟物占比体积和出处

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PDA TR64：温度验证等模拟物体积要占比80%

GB/T34399-2017：占比70%

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增加几个来源讨论

ISPE指南 Controlled Temperature Chambers 2nd Edition的观点很特别，似乎没有遇到有企业这么做过。在探头章节（12.4）要求在门区和腔体一半量放置，来实现最差的空气流动。

• 5.5.3.2 It may not be necessary to fully load the CTC to simulate a fully loaded test condition. If the design is symmetrical then a partial load can be justified.
• 12.4 The unit is considered as a number of zones that operate independently; the front (i.e., nearest the door) zone and a half will be filled with empty boxes simulating the largest stored product case. This scenario will give minimum thermal mass, but maximum interruption of airflow, allowing the effect on the temperature distribution to be seen in the filled zones
  

WHO的要求似乎就是不需要做模拟装载，甚至还专门note了一下所谓的“full storage"是指正常运行情况下。不过即使做了模拟装载应该也不会构成违背
参见WHO TRS 992的Annex 5 <Technical supplements to Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products>其中的《Supplement 7 Qualification of temperature-controlled storage areas》（https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/distribution/trs961-annex9-supp7.pdf）

• 2.2.3 PQ is carried out with the storage area or equipment fully operational, loaded and having been allowed to reach stabilized conditions. The following tests and checks should be carried out:
• --- temperature control and temperature distribution;
• --- temperature recovery following a door opening.
• Note: In this context “loaded storage space or equipment” means that the store or equipment has begun to receive products and normal operations have commenced.
• 2.6.2 Temperature mapping – full T he temperature mapping exercise described in section 2.5.6 is repeated as for OQ, but with the storage area loaded normally with TTSPPs. The same arrangement of EDLMs should be used for the PQ mapping as for the OQ mapping.
  
  

USP 1079的意思和WHO的有点像，参见1079.4 (01-May-2024)章节6。这个里面最后一句话提到模拟装载不应高于实际装载（此处应该是指热容？），似乎也没见有企业这么核算过
Load tests may be conducted with actual product or with simulated product, which should simulate the expected average thermal mass of the actual product). While this may be possible for smaller storage areas, it may not be practical for larger areas. The thermal load should never be higher than the actual product.