求助 关于仓库验证问题

x349440292

   我公司新建仓库划分阴凉库、冷库、冻库若干。我想问下关于如何布点、验证时间、以及合格依据是什么？对于仓库大小和布点数目的关系有无可GMP依据条款？

石头968

kington 发表于 2013-1-19 11:39
Step 3 – Establish Data Logger Criteria and Select  第3 步－建立数据记录仪的标准和选型  
Temperatu ...

有指导意义，非常感谢

kington

，具体是那个机构的指南不清楚，我们是这么做的，供参照。
Temperature & Temperature/Humidity Mapping Guide 温度和温湿度图指南  
Recently FDA regulations including HACCP, various CFR code of federal regulations, and  the  push  to  eliminate  wasted  time  and  money  in  fixing  temperature  related product  failures  has  made  Temperature and  Temperature/Humidity  Mapping  an integral aspect of any warehouse operation.  
最近，包括HACCP，各种联邦法规在内的FDA 法规，和对于降低温度相关产品安装失败所造成的时间和财力浪费的期望，使得制作温/湿度分布图成为所有仓库运行中不可或缺的一部分  
Inadequately controlled environments can lead to ineffective medicines, spoiled produce, damaged materials and frequent critical equipment failures. This all ads up to wasted dollars. Fortunately the cost of monitoring large warehouses has dropped significantly over the years as temperature and temperature/humidity sensing technology has become more accurate, easier to use and more affordable.  
不适当的控制环境会导致药品无效、毁坏的产品、损坏的原料，关键设备频繁的故障。这些会浪费金钱。幸运的是，由于温度或温湿度传感技术变得更精确、更容易，更经济；对大型仓库的监测费用明显下降。  
Whether you are concerned about maintaining a consistent temperature in a 5,000 or 500,000 sq. ft. warehouse, you’ll want to make sure that you are using the right tools for the job and that you’re using them correctly.  
无论你是否关心一个5000 或5000000 平方英尺仓库的温度均一性，你都会想要确定在你的工作中使用了一个正确的工具，并且能够正确的使用它们。  
In this guide, we will discuss best practices for mapping temperature in large spaces.  
在这个指南里，我们会讨论一个最好的方法，在一个大的空间里绘制温度图。  










Planning Your Steps:
计划步骤  
Mapping is not a one-time job, but an ongoing process that takes into account changes in seasons, HVAC/R modifications, warehouse layout modifications and any other significant changes to the warehouse environment. Proper organization and documentation are critical in maintaining compliance and consistency.  
制作温/湿度分布图不是一次性的工作，而是需要考虑季节的变化，HVAC/R的改造，仓库布局的改变和任何其它对仓库环境的重大变更，人员组织和文件化工作是保持顺应性和一致性的关键。  
Step 1 – Determine Critical Mapping Points  
         确定关键绘制点  
Step 2 – Determine Sample Rate  
         确定采样频率  
Step 3 – Establish Data Logger Criteria and Select  
         建立数据记录仪的标准和选型  
Step 4 – Place Data Loggers at Pre Determined Points  
         在每一个确定的点，安置数据记录仪  
Step 5 – Retrieve, download and evaluate Logged Data  
         收集、下载、评价采集的数据  
Step 6 - Document Processes and Repeat  
         过程和报告的文件化  
Step 7 – Data Logger Maintenance and Calibrations  
         数据记录仪的维护和计量  
Step 8 – Remediation  
         纠正  Step 1 – Determine Critical Mapping Points  第1 步－确定关键绘图点  
Problem Locations:  
Large open spaces present a considerable challenge when working to maintain a consistent temperature or temperature/humidity level. Problem spots include:  在较大而且开放的空间里，要保持稳定的温度或温/湿度水平被认为是很有挑战性的。会出现的问题包括：  
    * Areas near the ceiling or exterior walls may stay warmer or cooler in response to temperatures outside.      * 接近天花板和外墙的区域会受到外界温度的影响而延缓制冷和制热的效果
    * Temperature levels stratify due to the fact that warmer air rises.
    * 热空气上升导致温度水平分层
    * Temperatures will tend to be higher near heaters. If fans are undersized or        improperly placed they will be incapable of mixing the heated air effectively.
    * 在靠近加热器的地方温度会升高。如果风扇太小或安装位置不合理，则它不能有效的混合热空气。      * Racking, shelving and pallet storage areas may create “hot spots” by obstructing air circulation.      * 由于包装材料、货架、货盘储存区域会影响空气的循环，所以造成“热点”      * Doors that are left open will affect temperature conditions.      * 单向开的门会影响温度条件。  
Additional Locations:  
In addition to problem spots logger placement is also critical for the following locations:  
另外，数据记录仪应该摆放在如下的关键位置。      * HVAC outputs
    * HVAC 的出风口
    * Exits to unconditioned spaces (loading docs and staging areas)
    * 通向非温控区的出口（装载码头和中转存放区）
    * Outside (to compare outside temperatures to internal temperatures)      * 出口（比较室内和室外的温度）
    * High, medium and low locations in the general storage area
    * 一般存货区的高中低位。

Spacing:间隔  
Studies have shown that a spacing of every 3,000 to 5,000 feet in an open warehouse plan, without walls to block airflow, is adequate enough to accurately represent readings that are meaningful. A distance of greater than every 5,000 feet may yield data that does not accurately reflect conditions in the warehouse space, while spacing data loggers closer than every 3,000 feet will result in extra data that adds no value while creating extra work.  
研究表明，在一个开放的仓库里，不考虑墙和阻碍物，每3000 到5000 英尺内的温度是足够精确的了。距离超过5000 英尺，产生的数据不能真实的反映仓库的条件。如果数据记录仪的间隔小于3000 英尺，会产生额外的没有价值的数据，增加工作量。  
Determination of critical mapping points should include all potential problem spots in addition to the normal storage area. Be sure to space the critical mapping points in an evenly distributed grid using every 3,000 to 5,000 feet as your spacing guide.

确定关键的绘图点，应该包括正常储存区域的所有潜在的问题点。在确定绘图点的时候，将空间平均分割，间隔为3000－5000 英尺。  
Step 2 – Determining Sample Frequency  第2 步－确定采样频率  
The key to determining sample frequency is to not take too many or too few samples. Too many samples will create too much data making analysis cumbersome and difficult. Too few samples will not adequately represent changes in the warehouse environment. In most warehouses, one temperature or temperature and humidity sample every 15 minutes should adequately evaluate temperature trends.  
确定采样频率的关键是不要太多，也不要太少。太多的采样，会造成大量的数据，分析起来太笨重也太复杂。太少的点，不能真正的反应仓库环境的温度变化。在大多数的仓库温度或温湿度采样为每15 分钟1 次，这足以用来评价温度的趋势了。  
If you think you need to take readings more frequently, consider the following:
如果你需要更多的采样频率，考虑以下的问题：

Scenario 1 假设情况1
10 data loggers sampling every 15 minutes for 1week will provide 6,720 sample points.  
10 个采样器每15 分钟采样，采样1 周产生6720 个数据。  
Scenario 2 假设情况2
10 data loggers sampling every minute for 1 week will provide 100,800 sample points.
10 个采样器每分钟采样，采样1 周产生100,800 个数据。  
Scenario 1 will provide the same general results as Scenario 2 with 1/15th of the data and much less time spent analyzing logged data.
第一种情况与第二种情况的结果相同，但是只有第二种情况的十五分之一的数据，而且用于分析数据的时间更少。  
The key here is response time. Most temperature data loggers take at least a minute to respond to changes in temperature, and in a space as large as a 50,000 sq. ft. warehouse, most changes will happen very slowly over several minutes, making frequent sampling unnecessary and wasteful.  
这里的关键是响应时间，很多温度数据记录仪的温度响应时间至少为1 分钟，在一个50000 平房英尺的巨大空间里，温度变换是缓慢的，且在较长时间内发生的，高频率的采样是没有必要的也是浪费的。  

kington

Step 3 – Establish Data Logger Criteria and Select  第3 步－建立数据记录仪的标准和选型  
Temperature and Temperature/Humidity Data Loggers come with many features. The goal is to select the data logger that will most effectively monitor your warehouse. Key features you should consider are:  
温度和温湿度数据记录仪有很多特点。选择数据记录仪的目的是有效的检测仓库的。关键的特点应该考虑：  
    * Data Capacity: Data Capacity determines how many readings or sample points        can be taken by a logger before memory is full. The more sample points a logger has, the more readings it can store.
* 数据容量：数据容量决定了在记录仪的内存存满之前，能够读取多少数据或多少采样点。越多的采样点，数据记录仪可以储存的数据就越多。
* Sample Rate: The frequency in which samples are taken. The logger should        feature user selectable sample rates.
    * 采样速度：采样的频率。使用者需要选择记录仪的采样频率。
* Monitoring Range and Accuracy: Be sure to select a data logger with a        temperature range that can monitor temperatures even in the most extreme of cases. Don’t pay extra for accuracy you don’t need. +/-2oF and +/-2% RH should be adequate for most warehouse mapping situations. For refrigerated storage areas or locations requiring tighter tolerances, data loggers with an accuracy of +/-.5 oF should be selected.
监测范围和精度：确保所选的温度记录仪的温度范围可以在最极限条件下进行温度的监测。不需要购买过高精度的仪器。对多数仓库分布图来说，+/-2华氏度 and +/-2% RH就足够了。对于冷冻仓储区域或需要严格控制的区域，应采用精度为+/-0.5华氏度的温度记录仪  
   * Size: Make sure the logger will fit in your selected locations. Some loggers are as small as a quarter making them perfect for tight locations or when you don’t want them to be noticed.     * 尺寸：确定采样器的尺寸适合你选择的位置。一些采样器的尺寸只有四分之一码，可以很好的安装在狭小的位置上。或者是你不希望它们被别人注意到。
   * Networking: Ethernet connectivity lets you view and download logged data and modify logger settings from your PC on any logger connected to your Local Area Network. These are perfect for smaller warehouse locations where critical items are stored and more frequent temperature readings are necessary.     * 网络：以太网连接可以使你在电脑上观看和下载连接在局域网上的数据记录仪的数据，并修改记录仪的设定。这对于那些存储关键物品的，需要更频繁的读取温度的仓库中的较小区域非常适用
   * Battery Life: Make sure the battery life is long enough to last between mapping sessions. Many data loggers feature battery life between one and five years. More than enough to last through several mapping sequences.     * 电池寿命：确认电池的寿命足够长，能够完成绘图的测定。一些数据记录仪的电池寿命在1－5 年。足够进行许多温度图的测定。     * Calibrations: Be sure to purchase your data logger from a manufacturer who is A2LA accredited, NIST traceable, ISO 17205 compliant and can provide calibration services. The data loggers should be calibrated at least every 12 months.
   * 校验：确定你购买的数据记录仪的生产商是被A2LA 确认的，NIST 可追溯的，符合ISO17205 的并且能够提供校验服务的。数据记录仪必须每12个月校验一次。
   * Software: Make sure the data logger software is easy to use and that you can export data into Excel for easy mapping of Mean Kinetic Temperature
* 软件：确信数据记录仪的软件是容易使用的，你能够将数据输出到Excel 中，容易绘制平均热力学温度图。

Be sure to purchase at least one data logger for each location.
   确信每个点都买了数据记录仪  
Step 4-Place Date Loggers at Pre Determined Points
第4 步－在每个确定的点安放数据记录仪  
Be sure to document the location of each data logger and label each data logger to ensure that it is repeatedly placed in the same location.  
确信每一个数据记录仪的安装位置都有文件记载，并且每一个数据记录仪都作了标记。确定每次摆放都在同一个位置。  
To ensure consistency practice the following rules:  
按照以下的原则来确定一致性  
   * Using the data logger software, name each logger by its location.
   * 使用数据记录仪软件，命名每个记录仪的位置。
   * Label the outside of each logger by its location     * 在每个记录仪的外面用标签表明它的位置。
   * Label the exact spot where the data logger should be placed by the data logger’s location name.     * 在数据记录仪上用记录仪的位置名字表明数据记录仪应该摆放的位置。
   * Create a physical map with all data loggers marked by name
   * 制作一张图标示出所有的数据记录仪的名字  
Step 5 – Retrieve and download Logged Data  第5 步－检索和下载采集的数据  
Once the loggers have been placed and data has been collected, collect the data loggers and transfer the logged data to your PC.  
当布置好记录仪并采集到数据后，收集数据记录仪的数据并把记录的数据传输到你的电脑中。  
The logged data can now be exported to Excel where Mean Kinetic Temperature can be calculated.  
记录下的数据现在可以输入到Excel 中，计算平均热力学温度。  
Mean Kinetic Temperature is a calculated fixed temperature that simulates the effects of temperature variations over a period of time. It expresses the cumulative thermal stress experienced by a product at varying temperatures during storage and distribution.  
平均热力学温度是计算能够以固定的温度值模拟一段时间内温度变化的效果。它反映了产品在存储和运输中经历多种温度所累积的热应力。  
The formula for Mean Kinetic Temperature is as follows:  
平均动力温度的计算公式如下：  
T_k  (.H/R)/(-ln (〖e^(-.H/RT)〗_((1))+〖e^(-.H/RT)〗_((2) )+⋯+〖e^(-.H/RT)〗_((n) ))/n)


Tk=Mean Kinetic Temperatue       平均热力学温度  
.H=the activation energy which is a constant of 9982.68 激活能量常数，＝9982.68  
R=the universal gas constant  通用气体常数  
T=the temperature in degree K(i.e. ℃+273.1)    开尔文温度  
n=the total number of (equal) time periods over which data is collected 数据采集的时间周期的总数  
e=the natural log base 自然对数底数

Application of this formula is more straight forward than if appears. T(1)is the average temperature recorded over the first time period, T(2)is the average temperature recorded over the second time period etc. to the nth time period.  
这一公式的应用比它看起来的要简单。T(1)是在第一个时间段中所记录温度的平均值，T(2)是在第二个时间段中所记录温度的平均值。  
In addition to calculating MKT it is also recommended that Min and Max temperatures should be monitored carefully and that the location and the time of day at which they occur should be recorded. Any trends should be investigated.  
除了计算MKT 外，也建议对温度的最低和最高值进行仔细监测，并记录出现极限值的位置和具体时间。应该对任何表现出的趋势进行调查。  
A free program to calculate Mean Kinetic Temperature is available at:

可以在以下地址找到计算平均动力学温度的免费软件：  
http://www.stabilitysystem.com/mkt.htm  
Step 6 - Document Processes and Repeat  第6 步－记录过程和重复  
Now that you have completed your first mapping, be sure to place the data loggers back in their original locations throughout the warehouse and make sure to document each and every step used.  
现在已经完成了第一次的分布。确认把数据记录仪放回它们在整个仓库空间中最初的位置，保证每一步和所有步操作都有文件记录。  
Step 7 – Data Logger Maintenance and Calibrations
第7 步－数据记录仪的维护和校验  
Over time the most robust data loggers can drift causing inconsistencies in recorded data thus requiring regular calibration in order to ensure accurate readings.  
经过一段时间之后，即使最耐用的数据记录仪也会发生偏差，导致所记录数据的不一致性，因此需要定期校验以保证精确的读数。  
It is recommended that each data logger be calibrated at least every 12 months. In addition, it is prudent to request before and after readings when calibrating each data logger so corrections can be made to previously logged and mapped data.

推荐的作法是至少每12 个月对每个数据记录仪进行校验。此外，在校验每个数据记录仪前后进行读数是很严谨的，这样有助于对之前记录和分布的数据进行修改。  
Best practice recommends sending the data logger to a NIST certified calibration facility, and to the original manufacturer for calibration whenever possible.  
推荐的最佳方式是把数据采集器送往NIST认证的校验机构，和原始制造商，如果可能的话。  
Step 8 – Remediation  第8 步－纠正  
Now that you have your results it is time to fix any trouble spots that show up in your calculations.  
现在已经有了结果，是时候该处理在计算中显示有问题的点了  
Common Fixes:  
常用处理手段  
   * Hot Spots: Hot spots are frequently caused by walls or shelving that block airflow and/or inadequately sized fans that are unable to circulate air. Increasing the size or number of fans and removing unnecessary walls or rearranging shelves to promote airflow is helpful.
   * 热点：热点通常由于墙壁或棚架阻碍了气流，和/或风扇尺寸不够，不足以使空气流动而造成的。
   * Wide Temperature Fluctuations: Frequent changes in temperature in one location can be caused by direct exposure to outside air sources. Doors that are habitually left open, sky-lights, open doc doors and hallways to nonconditioned locations can make maintaining consistent temperatures difficult. Plastic curtains over open hallway or dock entrances will block much of the hot or cold air from entering the warehouse space.
   * 温度的较大波动：某一点温度的频繁变动可能是由于直接暴露于外界空气中。习惯性敞开的门、顶棚透过的光线、敞开的门、通往非温控区域的走廊，这些位置会比较难于保持温度的稳定。开放式走廊的塑料门帘和码头式进入区能够阻挡许多热或冷的空气进入仓库空间。
   * Inability to maintain target warehouse temperature. If the overall warehouse temperature can not be maintained, an expert evaluation of the HVAC system is in order.     * 无法保持目标仓库的稳定。如果仓库整体温度无法保持，则需要对HVAC 系统进行专业评估。  

Conclusion    温度分布图在帮助企业符合法规要求，通过改进和提高效率创造降低成本的可能机会来说是非常有力的工具。关键是仔细分析仓库空间以保证数据记录仪的适当分布，文件记录仪的位置

jxfan

沙发一下，夏天冬天的数据

jxfan

梅雨季节的湿度

中华骏捷

按照面积合理布置。

玻璃杯

风评最差点

abc678

2楼谈详细；额

石头968

kington 发表于 2013-1-19 11:39
Step 3 – Establish Data Logger Criteria and Select  第3 步－建立数据记录仪的标准和选型  
Temperatu ...

有指导意义，非常感谢

那罗念恋

谢谢分享！

haosexiaomao

全英文的我有，请问朋友们谁有这个指南的中文版？

疯子小小

看完这个有几个问题需要咨询：1，怎么画布点图，布点的依据是什么？看到说有8+4+1的布点，出处是哪里呢？2，验证期间是否需要避免人员进出？但是貌似不能避免，这块需要怎么留意呢？

Liuxinyu

疯子小小 发表于 2019-11-27 13:54
看完这个有几个问题需要咨询：1，怎么画布点图，布点的依据是什么？看到说有8+4+1的布点，出处是哪里呢？2 ...

方案中设计人员进出记录

Liuxinyu

haosexiaomao 发表于 2018-8-4 17:19
全英文的我有，请问朋友们谁有这个指南的中文版？

全英文的我要，求分享

疯子小小

Liuxinyu 发表于 2019-11-27 19:14
方案中设计人员进出记录

好的，谢谢