 Is your organisation having tostart, or repeat, temperature mapping efforts due to increasing regulations onwarehouse storage and distribution practices? Are you facing difficulties inmaintaining control of the temperature distribution within your storage areas?Are you looking to implement a simple framework of validation testing that aimsto establish a sound strategy and approach for performing environmental mappingof 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 increasingawareness that storage areas need to be environmentally mapped to protectproduct quality and customer safety. A comprehensive temperature mapping studywill ensure that your storage area is accurately monitored, properly maintainedand 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 yourwarehouse or storage area can be time consuming work, but we offers practicalsolutions to simplify the validation process in five steps to ensure that it iscost effective for your business while maintaining the highest standards ofquality and reliability. The PharmOut approach is described in the flow diagrambelow: 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：
Understandregulatory requirements and comprehend architectural constraints 理解法规要求和条件限制 Before you begin to build thequalification plan, ensure that you understand the following requirements andconstraints: 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：
Createa plan and establish the strategy 制定计划和战略We leverages WHO and ISPE bestpractices for temperature mapping planning and implementation. One of the firststeps when creating a mapping plan is to identify the risks within your storagearea. 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 consideredas part of the mapping plan: 温度分布计划中以下风险点应该被考虑：
Typical SensorDistribution: 15 sensors covering allhorizontal and vertical planes in a typical three dimensional mapping of thistype of warehouse configuration. 典型探头分布：15个探头涵盖整个仓库的横向和纵向的仓库三维空间。 If your product is sensitive torelative humidity, it is necessary to use loggers that will record both thetemperature and relative humidity in the monitoring locations of your storagearea. For humidity mapping studies, the number of humidity loggers to be placedis typically fewer than then number of temperature loggers. These loggers areplaced in areas of highest risk (i.e. areas with poor circulation). 如果你的产品对湿度同样敏感，那么有必要选用温度和湿度同时能够监控的探头放置在存储区域，对于湿度分布测试，湿度探头通常少于温度探头的放置数量，这些放置在高风险区域（如：少风循环处）。 If data is gathered or analysedin electronic form, the data storage and analytical software must comply withregulatory requirements (US FDA 21CFR Part 11, PIC/S Annex 11, and EU GMPChapter 4). 如果数据收集或者分析是电子形式，数据的存储分析软件必须符合法规要求（USFDA 21CFR Part 11, PIC/S Annex 11, and EU GMP Chapter 4）。 Performthe mapping执行温度分布Once the risks are identifiedand assessed, with identified control strategies in place to mitigate anyrisks, the mapping equipment needs to be set-up and an initial mapping testperformed. The sensors must be labelled, programmed and fixed into position asdocumented in the qualification protocol. New environmentally controlled areasare initially mapped empty (i.e. without products). The purpose of this initialtest is to build a temperature / humidity profile and to identify potentialareas of unacceptable temperature and humidity for the product during thenormal loaded operation mapping. 一旦风险被识别和评估，以确定带来任何风险的控制策略，温度分布测试设备变成冰固定在文件规定位置，探头必须标记。新的环境控制区域需进行初始的温/湿度分布（即无产品）。目的是确定日常负载状态下产品对温湿度影响的潜在区域。 At the end of the study period,the devices are collected and the data is downloaded and consolidated foranalysis. 在测试最后阶段，数据从设备上被收集和下载汇总用于分析。 When the empty study iscomplete and the empty environmental profile determined, a normal loadedoperation mapping is performed. The normal loaded operation mapping istypically performed for a longer period of time than the empty mapping andduring extreme seasonal variation such as summer and winter. 空载测试完成后，进行负载温度分布测试。日常装载的温度分布分布一般比空载温度分布需要更长的测试时间周期，并且需要考虑季节变化，如夏季和冬季。 Recommendalterations 建议变化The results of the mappingexercise must be analysed and compared against the acceptance criteria asdefined in the qualification protocol. From the data, the analyst can identifycritical areas (hot and cold spots) where the stored product may potentially beexposed to unacceptable temperature and humidity conditions. With thisinformation, you can analyse if alterations are needed to counteract theextremities. This may include making changes to the HVAC system, re-positioningsensors, or re-locating shelves to a modified layout design. Depending on the alterationsproposed, an additional mapping study may be necessary to identify the newenvironmental profile and consequently the correct location of the monitoringsensor(s). 温度分布结果必须被分析和与确认方案的接受保证进行比对。从这些数据，分析人员能够确定找到可能影响产品温湿度不符合的关键区域（冷、热点），有了这些信息，你可以分析是否需要改变抵消这些不良因素。可能包括空调系统改变、重新布置探头、重新布局架子。根据改变，可能需要一个新增的温度分布测试，确认环境分布和监控探头位置正确。 Reportresults 报告结果The temperature mapping reportmust be simple and easy to understand. Complicated reports tend to attractquestions by auditors. The report should include all the data collected duringthe study, showing data points of each sensor, along with maximum, minimum andacceptable range limits. It should also include details of the testing andalterations if any, conclusions, and plans to conduct additional scheduledmapping. 温度分布报告必须可以简单容易理解。复杂的报告将更加吸引审计人员。该报告应包括所有温度分布收集的数据，每一个探头的数据、最大值、最小值和接受标准限度。它同时也应包括详细的测试和变化，如果有。结论和将进行的增加的温度分布测试时间表。 References 参考文献
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