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:
---------------------------------------------------------------------------------
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
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.
这{{threadTextType}}正{{isAdminText}}
为帮助审核人员更快处理,请填写举报原因:
为帮助审核人员更快处理,请填写举报原因: