仓库温度分布验证最差点变动后日常监控的温度探头需要变动吗
仓储运输

每次验证,同一库房的温度最差点会变动需要分析吗?

仓库监控探头需要随着验证的最差点来回变动吗?

2023-08-14 19:43 知守     
5个回答

温湿度监控探头的放置位置应基于温度分布验证的最差点(最冷和最热,一般是两个点)进行变动,可参考WHO技术报告相关规定,相关内容及连接如下:

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Technical supplement to WHO Technical Report Series, No. 961, 2011

Annex 9: Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products

May 2015   Supplement 8: Temperature mapping of storage areas

http://lib.shilinx.com/wiki/index.php?title=WHO_TRS_961_Annex_9_Technical_Supplement_8%3A_Temperature_mapping_of_storage_areas&searchText=temperature%20mapping


2.4.2 Minimum and maximum temperatures and hot and cold spots

A mapping study measures temperature fluctuations. From these data, the analyst can identify the minimum and maximum temperatures that occur in the mapped area during the study period.

Minimum temperature refers to the lowest temperature recorded in the mapped space over the study period; maximum temperature refers to the highest value recorded during the same period. Either or both of these temperatures may be outside the specified acceptance criteria for the store. Annex 1.3 shows a standard form that can be used to record these data, together with the mean values discussed in section 2.4.4.

A cold spot refers to the lowest temperature(s) recorded in the space over the study period, but these lowest temperature(s) remain within the specified temperature range (e.g. cold spots identified between +15.0 °C and +17.5 °C in a room with a specified temperature range of +15.0 °C to +25.0 °C).

A hot spot refers to the highest temperature(s) recorded in the area studied over the study period, but these highest temperature(s) remain within the specified temperature range (e.g. hot spots identified between +23.0 °C and +25.0 °C in a room with a specified temperature range of +15.0 °C to +25.0 °C).

The purpose of determining hot and cold spots is to identify the locations where the monitoring system sensors should preferentially be located. Hot and cold spots need to be determined seasonally as they may be significantly different in summer and in winter. Note: It is also important to look at the overall high and low trends rather than just the highest and lowest temperatures. Average values can be useful to help confirm true hot and cold spots.

2023-09-21 14:00 沐清风     

需要对数据进行分析,并根据差异大小进行评估,是否需要调整监控点的分布.

可以考虑差机组运营情况、参数的设置、季节、外界温度、异数值的大小、极值的持续时间和探头的精度,及产品的耐受程度,

同时,也需要考虑仓库日常运维过程的可执行性;

综合考量下,决定是否需要调整

2023-09-20 13:19 雨霖     

可能由于仓库内部的布局调整、贮存物品的存放方式、仓库空调设备的运行状况和季节变化,所以建议每次验证前进行分析以确定最差点的位置。 如果最差点发生变化,需要风险评估后进行相应地调整探头的位置,以确保监测能够覆盖到温度变化的关键区域。

2023-08-17 16:42 Stark     

最差点发生变化需要分析。

需要分析布点是否有调整,考虑空载和负载,夏季和冬季是否都发生相同趋势的变化;

是否涉及人员操作(如仓库开关门时间)以及HVAC系统的问题

如果设施、设备、HVAC系统、操作都有变化的话,最差点有变动也是正常

2023-08-15 09:19 Cora     

如果最差点发生变化,需要进行风险评估,确认需要进行温度分布再验证的,则需要再进行温湿度检测点的再确定。

2023-08-15 14:35 阳光蒲照