qualification of storage facilities

Qualification of storage facilities医药仓储与冷链的验证

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Qualification of storage facilities / 仓储设施验证

1. Basics of GxP

GxP基础

2. Calibration of Testo Loggers

数据记录仪校准

3. Qualification of storage facilities

存储设施验证

4. Validation of monitoring systems

监测系统验证

Regulative guidelines on storage 存储调节准则

Authorities and organisations as well as laws & sets of rules 权威组织及法律法规


RA, OQ/ PQ and Qualification Report / 风险评估,OQ/PQ及验证报告

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© Testo • Industrial Services GmbH, 2016

Structure / 结构

Time / 时间Time / 时间Time / 时间

DQDQ

Riskanalysis

Riskanalysis

IQIQ OQOQValidationfinal reportValidationfinal report

VMPVMP

QualificationQualification Process validationProcess validation

Process validationCleaning validationMethod validation

Process validationCleaning validationMethod validation

Validation

PQPQ


Validation masterplan / 验证总计划

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• When do I have to do a mapping? / 何时需要做温湿度分布验证? 1. Before using the storage facility / 在开始使用仓储设施前

2. After reconstruction of the premises / 在建筑物重建后

3. Change of the HVAC / 在暖通空调变化后

4. Change of the storage area or loading amount / 在改变存储区域和装载量后

5. Identification of monitoring sensor distribution - Testo Saveris / 在监测系统-Testo Saveris

系统鉴定时

• What types of mapping have to be completed? /

• 哪种类型的温湿度分布验证需要完成?1. Winter and summer mappings / 冬季和夏季的温湿度分布验证2. With and without load / 空载还是满载

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4 steps for successful qualification of a storage facility:

仓储设施成功验证的 4个步骤1. Create qualification plans

创建验证计划

(RA and OQ/PQ Plan)

(RA和OQ/PQ计划）

2. Set up mapping equipment

设定mapping设备

3. Evaluate test data

测试数据评估

4. Create qualification report

创建验证报告

(OQ/PQ Report) / (OQ/PQ 报告)

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Step 1: Create qualification plan / 步骤1：创建验证计划(A) Risk analysis / 风险评估:

Considering each of these factors will help you to define risk:考虑以下因素将助于定义风险:

Capacity of diffusers or fans to adequately circulate air

扩散器或风扇使空气充分流通的能力

Temperature gradients between the cooler floor and warmer air near the ceiling

更冷的地板和更热的空气在天花板处的温度梯度

Independent energy sources, such as space heaters, air conditioners, and fans, which create warm or cold pockets.

独立的能源装置，如空间加热器、空调、风扇等制热或制冷设施

Layout of racks, shelves, and pallets, which obstruct airflow.

货架和托盘的布局会影响阻碍气流

Location of HVAC control sensors

暖通空调控制感应器的位置

Locations near sources of heat or cold, such as the roof and exterior walls, windows, and loading dock

冷热源的位置，如屋顶、外墙、窗户和装货站

High-traffic areas where product or equipment is moved

产品或设备高频流动的区域

Seasonal temperature changes or unusual weather events

季节性温度变化或异常天气事件

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Step 1: Create a qualification plan / 步骤1：创建验证计划

(B) OQ/PQ Plan / OQ/PQ方案: Once areas of risk are identified, a protocol for the mapping test in the OQ plan must be developed, which describes the following factors, with justifications for each decision:

一旦确定好风险区域后，包含以下内容的温湿度分布式验证方案OQ方案需建立，含每个决定的判断

Types of data to be generated – for example, temperature, relative humidity, and measurement intervals.

要生成的数据类型 – 如温度、相对湿度、测量间隔等

Number of sensors to be used 使用的传感器数量

Map of sensor locations. 传感器位置图

Duration of study 测试持续时间

Calibration requirements of the data loggers. 数据记录器的校准需求

Acceptable range of variation over time and across the space, which will depend on the product stored.

根据产品存储情况，可接受的变化范围的时间和整个空间

Acceptable limits for temperature or relative humidity excursions.

可接受的温度和相对湿度漂移的极限

Reporting requirements.

报告需求

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(B) OQ/PQ Plan / OQ/PQ方案

How many sensors will you need to map a space? 需要多少传感器？• Place sensors in an uniform pattern in all three dimensions of your space – top to bottom, left to right,

front to back

在三维方向按统一模式放置传感器 – 从上到下，从左到右，从前到后

• Add additional sensors where you suspect cool or warm areas may exist, as well as near the control sensors and monitoring sensors

在可能有冷热区域存在的地方放置额外的传感器，以及靠近控制传感器和监测传感器

WHO Technical Report Series, No. 961, 2011: WHO 技术报告系列，第961,2011号• Length and width: every 5-10 meters 长度和宽度: 每隔5-10米

• Height: the bottom, middle and top of the space 高度: 上、中、下

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(B) OQ/PQ Plan / OQ/PQ方案:

Walk-in chamber or small warehouse:

步入式空间或小仓库

is often mapped in three dimensions with 15 sensors

经常在空间上使用15个传感器

Large warehouse:

大仓库

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(B) OQ/PQ Plan / OQ/PQ方案:

Duration of mapping / 验证持续时间 : Warehouse: minimum 7 to 10 days 仓库: 至少7到10天

rooms and cold rooms: between 24 and 72 hours 常温库及冷库: 24到72小时

Fridge: 6h 冰箱: 6小时

Measuring rate / 测量频率: Frequency: < = 5 minutes 测量频率: < = 5分钟

Measurement accuracy / 测量精度: Data loggers have an error rate of no more than ± 0.5°C and 5% RH

使用的数据记录仪的最大允许误差不大于± 0.5°C 及 5% RH

*WHO Technical Report Series, No.961, 2011 -Annex 9: Model guidance for the storage and transport of time-and temperature–sensitive pharmaceutical products

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CFDA GSP附录5 库房温湿度分布验证要求

第六条企业应当根据验证的内容及目的，确定相应的验证项目。（一）冷库验证的项目至少包括：

1. 温度分布特性的测试与分析，确定适宜药品存放的安全位置及区域；

2.温控设备运行参数及使用状况测试；

3. 监测系统配置的测点终端参数及安装位置确认；

4.开门作业对库房温度分布及药品储存的影响；

5.确定设备故障或外部供电中断的状况下，库房保温性能及变化趋势分析；

6.对本地区的高温或低温等极端外部环境条件，分别进行保温效果评估；

7.在新建库房初次使用前或改造后重新使用前，进行空载及满载验证；

8.年度定期验证时，进行满载验证。

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第七条应当根据验证对象及项目，合理设置验证测点。

（一）在被验证设施设备内一次性同步布点，确保各测点采集数据的同步、有效。

（二）在被验证设施设备内，进行均匀性布点、特殊项目及特殊位置专门布点。

（三）每个库房中均匀性布点数量不得少于9个，仓间各角及中心位置均需布置测点，每两

个测点的水平间距不得大于5米，垂直间距不得超过2米。

（四）库房每个作业出入口及风机出风口至少布置5个测点，库房中每组货架或建筑结构的

风向死角位置至少布置3个测点。

第八条应当确定适宜的持续验证时间，以保证验证数据的充分、有效及连续。

（一）在库房各项参数及使用条件符合规定的要求并达到运行稳定后，数据有效持续采集时间

不得少于48小时。

第九条应当确保所有验证数据的真实、完整、有效、可追溯，

并按规定保存。

第十条验证使用的温度传感器应当经法定计量机构校准，

校准证书复印件应当作为验证报告的必要附件。

CFDA GSP附录5 库房温湿度分布验证要求

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WHO世界卫生组织对温湿度自动监测点的要求(法律法规要求)

（一）长度和宽度：电子数据记录仪（EDLM）应沿着区域的平面分格线每5~10米进行放置，这样

可以合理覆盖整个区域，在选择放置感应器的位置时要考虑。

（二）如果顶高为3.6米或更低，可以直接将电子数据记录仪（EDLM）放置在高中低位置

（例如，在地板面、1.2米、3.0米高处各放置一个电子数据记录仪（EDLM））。

（三）如果顶高大于3.6米，则电子数据记录仪（EDLM）可以按序放置在垂直方向的上中（可以

多个）下部。例如，对于高6米的存贮区域，电子数据记录仪（EDLM）可以在0.3米、1.8米、

3.6米、5.4米位置各放置一个。

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Step 2: Set up mapping equipment / 步骤2: 设定验证用设备

Work through the following checklist and make sure each step is completed and documented: 检查以下每一步是否已完成并记录

Equipment has been calibrated

设备已校准

Data logger locations are precisely described

数据记录仪的位置已精确描述

Regular sample intervals have been determined

测量采样间隔时间已定义

Test duration has been determined

测量持续时间已定义

All data loggers are set to begin and end at the same time

所有数据记录仪已设定同一开始和结束时间

Data loggers have been positioned in defined locations

数据记录仪已放置在定好的位置

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Step 3: Evaluate test data / 步骤3: 评估测试数据• Calculated values such as temperature minimum, maximum, and average

最高温度、最低温度和平均温度的计算

• Graph of all sensors during the test period

测试期间所有传感器的数据图表

• Identify high-risk locations, especially where problems occur sporadically and where the product would be exposed to unacceptable extremes of temperature or humidity

识别高风险区域，特别是当问题偶尔发生以及产品将暴露在不可接受的极限温湿度环境下

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Hum

idity

(%RH

)

Tempe

rature

[°C]

Time

Summer mapping of a storage facilityAcceptable limits: +5 ‐ +25°C / 30 ‐ 60 % RH

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Step 4: Create qualification report / 步骤4: 创建验证报告

The qualification reports typically include the following information's:

通常验证报告包含以下信息

• Calculated values such as temperature minimum, maximum, span, and average

最高温度、最低温度、跨度和平均的计算值

• Raw data with times and dates 含日期和时间的原始数据

• Graph of all sensors over the test period 所有传感器在测试期间的数据图表

• Instrument settings 仪器设定

• Calibration information 校准信息

• Date and time of the test 测试的日期和时间

• Locations where the product would be exposed to unacceptable extremes of

temperature or humidity 产品将暴露在不可接受的极端位置的温度和湿度

• Decision where products will not be stored and description of the non-storage locations

决定将不存储的产品和非存储位置的描述

• Recommendation for sensor distribution of the monitoring system – Testo Saveris

监测系统 – Testo Saveris探头分布的建议

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Recommendations / 建议:

• TTSPS can safely be stored in the mapped area. These

recommendations should take account of any temperature deviations identified

during the study as well as the approved temperature range(s) for the products

being stored in the area.

TTSPS（对温度敏感类产品）可存储在已做过温湿度分布验证的区域。那些被批准的产品可存储的温度范围需考虑测试时的温度偏差情况。

• Identifying the best places to locate temperature sensors, for routine monitoring,

in circumstances in which a monitoring system is installed. If a monitoring system is

already installed, identify the best places to re-locate temperature sensors (if

necessary).

识别最佳的安放传感器的位置，用于已安装有监测系统的常规监测，如有需要，可重新定位传感器的最佳安放位置。

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Conclusion / 结论:• The storage of pharmaceuticals underlies laws

药品的存储遵照法律法规

• Suitability of the storage facilities must be demonstrated Mapping

存储设施的适宜性必须证明 Mapping

• Storage conditions must be monitored Monitoring System this must be validated

存储条件必须被监测监测系统必须经验证

• The sensors have to be calibrated Calibration

传感器必须被校准校准

Testo can do / Testo能做: Calibration / 校准

Mapping / 温湿度分布验证

Saveris Validation / Saveris验证

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Mapping

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近期主要Mapping客户

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Mapping报告

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