仓库温度分布测试

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

4推荐转化

3执行方案

5报告结果

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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。

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Source of heating and cooling components 加热和降温

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Complete a site survey to identify components 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 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：

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 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 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。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 locations and distribution, set point value, data to be generated, and reporting requirements.

温度分布策略中应详细说明：选择多少探头、什么型号、探头位置和分布、设定值、数据形成，报告要求。

Establish a periodic environmental mapping program to ensure continuous compliance. The program should also outline additional mapping requirements such as when changes affect the airflow pattern.

建立周期性的环境温度分布测试方案，确保持续的法规符合。当气流发生变化时，方案中应说明需要进行额外的温度分布测试。

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Write mapping protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). 编写温度分布测试方案，包括IQ、OQ和PQ.

When determining the sensor locations, it is important to document a rationale for choosing the locations, as well as create a diagram that provides a visual map of the locations. It is essential that every sensor be accurately identified by a unique ID number and a defined location.

当确定了传感器位置时，书面说明选择传感器位置的理由，同时具备一份直观的位置布局图是很重要的。至关重要的是每一个探头应该有一个准确的ID号码和确定的位置。

With regards to determining the number of sensors appropriate for your temperature mapping effort, there is no set formula. Guidelines suggest placing sensors uniformly throughout all three dimensions of the storage area. The number of sensors used must be enough to provide an accurate assessment of the temperature distribution in the area. A rough estimate is that a small area of 12mx12mx12m requires 15 sensors to cover the edges and middle of each dimension, where the sensors are no more than 6m apart.

对于进行温度分布所需探头数量，没有固定的公式。指南建议均匀放置探头到整改存储空间内。探头数量必须能够提供该区域的温度分布的精确评估。一个粗略的估计是12mx12mx12m需要15个探头覆盖高整个边缘和各个空间中。探头之间不超过6m距离。

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上层 中层 下层

Typical Sensor Distribution: 15 sensors covering all horizontal and vertical planes in a typical three dimensional mapping of this type 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 to relative humidity, it is necessary to use loggers that will record both the temperature and relative humidity in the monitoring locations of your storage area. For humidity mapping studies, the number of humidity loggers to be placed is typically fewer than then number of temperature loggers. These loggers are placed 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 analysed in electronic form, the data storage and analytical software must comply with regulatory requirements (US FDA 21CFR Part 11, PIC/S Annex 11, and EU GMP Chapter 4).

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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（US FDA 21CFR Part 11, PIC/S Annex 11, and EU GMP Chapter 4）。

Perform the mapping执行温度分布

Once the risks are identified and assessed, with identified control strategies in place to mitigate any risks, the mapping equipment needs to be set-up and an initial mapping test performed. The sensors must be labelled, programmed and fixed into position as documented in the qualification protocol. New environmentally controlled areas are initially mapped empty (i.e. without products). The purpose of this initial test is to build a temperature / humidity profile and to identify potential areas of unacceptable temperature and humidity for the product during the normal 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 for analysis.

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 is complete and the empty environmental profile determined, a normal loaded operation mapping is performed. The normal loaded operation mapping is typically performed for a longer period of time than the empty mapping and during 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。

Recommend alterations 建议变化

The results of the mapping exercise must be analysed and compared against the acceptance criteria as defined in the qualification protocol. From the data, the analyst can identify critical areas (hot and cold spots) where the stored product may potentially be exposed to unacceptable temperature and humidity conditions. With this information, you can analyse if alterations are needed to counteract the extremities. This may include making changes to the HVAC system, re-positioning sensors, or re-locating shelves to a modified layout design. Depending on the alterations proposed, an additional mapping study may be necessary to identify the new environmental profile and consequently the correct location of the monitoring sensor(s).

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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。

Report results 报告结果

The temperature mapping report must be simple and easy to understand. Complicated reports tend to attract questions by auditors. The report should include all the data collected during the study, showing data points of each sensor, along with maximum, minimum and acceptable range limits. It should also include details of the testing and alterations if any, conclusions, and plans to conduct additional scheduled mapping.

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



WHO Technical Supplement. Temperature mapping of storage areas WHO技术补充。存储区域温度分布

 ISPE Good Practice Guide – Cold Chain Management (2011) ISPE良好操作规范- 冷链管理（2011）