Understanding Temperature Mapping仓库温度分布测试探讨Is your organisation having to start, or repeat, temperature mapping efforts due to increasing regulations on warehouse storage and distribution practices? Are you facing difficulties in maintaining control of the temperature distribution within your storage areas? Are you looking to implement a simple framework of validation testing that aims to establish a sound strategy and approach for performing environmental mapping of storage areas?是否你的公司已经开始、或者重复进行温度分布测试活动，以便增加在仓库储存和分发上的法规符合性？你是否正在面对库房存储区域的温度维护控制的困难呢？你是否正在找一个可实现的验证测试，目的就是要建立一个合理的策略和方法用于存储区域的环境温度分布。
There is an increasing awareness that storage areas need to be environmentally mapped to protect product quality and customer safety. A comprehensive temperature mapping study will ensure that your storage area is accurately monitored, properly maintained and in compliance with all the applicable regulations.现在大家越来越意识到存储区域需要环境温度分布用于保障产品的质量和用户安全。
一个全面的温度分布测试将能够确保你的存储区域被精确监控、妥善维护和符合所有法规。
Temperature mapping of your warehouse or storage area can be time consuming work, but we offers practical solutions to simplify the validation process in five steps to ensure that it is cost effective for your business while maintaining the highest standards of quality and reliability. The PharmOut approach is described in the flow diagram below:仓库或者存储区域的温度分布可能会是费时的工作，但是这里提供了5步法简化验证过程，流程图如下：1.法规要求2制定计划和建立策略3执行方案4推荐转化5报告结果Understand regulatory requirements and comprehend architectural constraints理解法规要求和条件限制Before you begin to build the qualification plan, ensure that you understand the following requirements and constraints:在开始起草确认计划之前，确保你明白接下来的要求和准则：▪Calibration 校验The calibration of temperature control devices and temperature monitoring devicesmust be evaluated. Calibration must be within a year’s validity, traceable to a national/ international standard such as NIST, and the devices must be calibrated to threepoints based on the temperature range required for product storage.温度控制设施和温度监控设施的校验必须被评估，校验必须在一年有效期内，能够追溯到国际标准校验如NIST. 设施必须被校验三个点，三个点需涵盖产品温度存储温度范围。
▪Environmental range and set point 存储环境和设定温度The environmental range needs to be specified in accordance with the range of thetemperature-sensitive product stored in the storage area, as specified in the productspecification. This may vary between products and the most critical range should bespecified in this case.产品储存条件需要根据产品特性来制定，同时也应该在产品质量标准中说明。
在这种情况下，储存条件可能与实际控制的范围有点不同。
The set point can be a fixed value or a variable value based on different seasons,external climate conditions, and time. Considerations must be made during planningtowards using a variable set point value, with additional or extended mapping periodsbeing the most common approaches.根据季节、外部条件或者时间不同设定值可以是一个固定值或者一个可变值。
必须考虑使用一个可变的设定值，并增加或者更大范围的温度分布周期是常用的方法。
▪Source of heating and cooling components 加热和降温Complete a site survey to identify components that may have an impact on theenvironmental profile of the storage area. The survey must identify sources oftemperature variability such as fans, windows, racks/shelves close to the roof orexternal walls, generators, vents and diffusers. Sensor(s) located near sources ofheating or cooling components may cause increased variability of monitoring data.完成现场检查以确定部件能够很好的控制存储环境状况。
调查必须确定温度变化因素，如风机、窗户、货架洁净的屋顶或者外墙、发电机、通风口。
温度传感器放置于邻近加热和冷却装置附近可能导致监控数据的变化增加。
Create a plan and establish the strategy 制定计划和战略We leverages WHO and ISPE best practices for temperature mapping planning and implementation. One of the first steps when creating a mapping plan is to identify the risks within your storage area. The diagram below shows a typical warehouse layout.我们利用WHO和ISPE温度分布计划和实施规范，第一个步骤通过确定存储区域风险点制定温度分布计划。
下图为一个典型的仓库布局平面图。
The following risks should be considered as part of the mapping plan:温度分布计划中以下风险点应该被考虑：▪Goods stored close to the loading dock may be affected by drafts.存储区域接近收发货区域的▪Goods stored near the north-facing wall and windows may be affect e d by solar heat.受太阳光影响较多的北面墙和窗的货物存储区域。
▪Lights can be a source of heat. Goods placed on high racking in close proximity to a light may be at risk.灯被认为是热的来源。
存储在高处靠近灯的货物可能存在风险。
▪Goods movement and other activity in the more trafficable areas of the warehouse is likely to cause drafts货物在仓库的移动或者搬运活动可能造成的气流。
▪Goods stored on tall racking is likely to have a wide temperature variation from top to bottom.货物存储从高位到底部可能会有一个大的温度变化。
These identified vulnerable areas should have additional sensors placed to gain a better mapping of hot and cold spots. Other risks to consider include total volume of space, air circulation, layout of shelves and racks, HVAC capacities, outside air temperature and humidity, etc.这些确定的较大风险的地方应额外的放置一些温度探头以便获得更好的冷点和热点分布。