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1、北京齐力佳 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 you
2、r 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
3、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
4、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 ef
5、fective 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. 法规要求法规要求 2 制定计划和制定计划和 建立建立策策略略 3 执行方案执行方案 4 推荐转化推荐转化 5 报告结果报告结果 北京齐力佳 Understand regulatory
6、 requirements and comprehend architectural constraints 理解法规要求和条件限制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 校验校验 The calibration of temperature control devices and tempe
7、rature monitoring devices must be evaluated. Calibration must be within a years 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
8、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 存储存储环境环境和设定和设定温度温度 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 b
9、etween 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 pla
10、nning 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 加热和加热和降温降温 北京齐力佳 Complete a site survey to identify compone
11、nts that may have an impact on the environmental profile of the storage area. The survey must identify sources of temperature variability such as fans, windows, racks/shelves close to the roof or external walls, generators, vents and diffusers. Sensor(s) located near sources of heating or cooling co
12、mponents 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 制定计划和战略制定计划和战略 We leverages WHO and ISPE best practices for temperature mapping planning and impl
13、ementation. 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 mappin
14、g plan: 温度分布计划中以下风险点应该被考虑： 北京齐力佳 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 affected 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
15、 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
16、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。其他风险考 虑包括总的空间体积、空气循环、架子的布局、空调能力、外界温湿度等。 Develop the mapping strategy detailing the number of sensors to be used, type of loggers to be used, sensor lo
