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 devices
must 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 three
points 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 the
temperature-sensitive product stored in the storage area, as specified in the product
specification. This may vary between products and the most critical range should be
specified 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 planning
towards using a variable set point value, with additional or extended mapping periods
being 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
