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Temperature and Humidity Monitoring in Warehouses

Trusted GxP compliance for simple or complex storage facilities

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Temperature and Humidity Monitoring in Warehouses

Trusted GxP compliance for simple or complex storage facilities

Whether GMP, GDP, or HACCP, cold rooms and warehouses must be monitored by an independent monitoring system regardless of whether raw materials, pharmaceutical products or foodstuffs are involved. During the qualification of the room, monitoring points for temperature and relative humidity are identified. To select the right monitoring solution in warehouses, the following questions arise:

  • Number: Is it a single storage room, multiple rooms, or warehouses?
  • Location: Are all storage locations in the same place or distributed across many locations? Do mobile warehouses and intra-logistics also need to be monitored?
  • Alarming: Is local visual/acoustic alerting more important or central 24/7 alerting via email & SMS?
  • Reports and data storage: Should the data and reports be stored locally or centrally in a database?
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Determining the location and number of temperature measurement points in the warehouse

The number of temperature measuring points in a GxP-qualified cold store or warehouse is determined by means of a winter and a summer mapping. This results in the warmest and coldest points where the temperature must be continuously monitored. In very large warehouses, temperature sensors are sometimes installed at additional locations for safety and risk considerations.

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Does humidity need to be monitored in the warehouse? Where?

GDP does not make any firm regulations regarding humidity. In the GMP environment where open products are stored or processed, humidity must be monitored. Relative humidity plays an important role in the quality of many other products. Humidity is distributed very quickly and homogeneously within a room. It is therefore usually sufficient to monitor the relative humidity per room at a single central point.

Temperature Monitoring of a small Storage Room
(+15 °C to +25 °C)

 

In a small non-qualified indoor space where goods are stored at room temperature, it is often sufficient to monitor the temperature

at a single, central measuring point. In the following video, we discuss the requirements and present three possible solutions.

 

See the table below for a direct product comparison of three monitoring solutions for a single storage room.

PDF/Bluetooth® data logger
LIBERO CL

If you just need compliant monitoring.

 

 

 

  • GAMP®5 & FDA 21 CFR Part 11 compliant
  • Alarming on display
  • Manual read-out & reporting
  • Local archiving of PDF report
  • Battery-powered sensor (battery not replaceable)
  • Free calibration certificate
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PDF/Bluetooth® data logger wireless sensor LIBERO W

If you need compliant monitoring and want local alarming.

 

 

  • GAMP®5 & FDA 21 CFR Part 11 compliant
  • Alarming on display, Local audio-visual alarming
  • Manual read-out & reporting
  • Local archiving of PDF report
  • Battery-powered sensors (replaceable battery)
  • Free calibration certificate, Re-Calibration options
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Mobile-IoT data logger
LIBERO GL

If you need compliant monitoring and want remote alarming also on weekends & holidays.

 

  • GAMP®5 & FDA CFR 21 Part 11 compliant
  • Alarming on display, 24/7 alarming via email & SMS
  • Automated reporting
  • Online database accessible via web-browser
  • Battery-powered sensor (battery not replaceable)
  • Free calibration certificate
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Temperature Monitoring Cold Rooms and Warehouses

 

Cold rooms, warehouses and handling areas in the GxP environment need to be qualified and monitored. In this video, we discuss the requirements and solutions for larger warehouses.

In the table below you will get a direct product comparison of three monitoring solutions suitable to monitor temperature and humidity in large warehouses.

Mobile-IoT data logger LIBERO GL

Easy installation, without local network.

 

  • GAMP®5 & FDA CFR 21 Part 11 compliant
  • 24/7 alarming via email & SMS
  • Automated reporting
  • Online database accessible via web-browser
  • Battery-powered sensor (battery not replaceable)
  • Free calibration certificate
  • Compatible with other devices
Order Now

Wireless sensors
RBR & 1NTR

Local antenna and battery powered wireless sensors.

 

  • GAMP®5 & FDA CFR 21 Part 11 compliant
  • 24/7 alarming via email & SMS
  • Automated reporting
  • Online database accessible via web-browser
  • Battery-powered sensor (replaceable battery)
  • Free calibration certificate
  • Compatible with other devices
Order Now

Monitoring system
ECOLOG Unlimited

Everything under own control: network, software and data.

 

  • GAMP®5 & FDA CFR 21 Part 11 compliant
  • 24/7 alarming via email & SMS, Local alarming with lamps & horns
  • Automated reporting
  • Local database on own servers
  • Wired or wireless sensors
  • Customer-specific on-site calibration
  • Compatible with other devices
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Monitoring Distributed Infrastructure & Intra-Logistics

 

Are your storage facilities spread across different buildings - or even different locations or countries? Do you also need to monitor intra-logistics as goods move between warehouses and locations? In this video, we discuss the requirements and solutions for distributed infrastructure and moving objects.

In the following table you will get a direct product comparison of two monitoring solutions that are suitable for distributed structures.

Mobile-IoT Data Logger LIBERO GL

Suitable for single measurement points in a distributed infrastructure, outdoor warehouses and intra-logistics (containers, trucks).

 

  • GAMP®5 & FDA CFR 21 Part 11 compliant
  • 24/7 alerting via email & SMS
  • Automatic reporting
  • Online database, access via web browser
  • Battery powered sensor (battery not replaceable)
  • Free calibration certificate
Order Now

Radio system with wireless sensors

Suitable for a distributed infrastructure in places where there are several measuring points in the same building.

 

 

  • GAMP®5 & FDA CFR 21 Part 11 compliant
  • 24/7 alerting via email & SMS
  • Automatic reporting
  • Online database, access via web browser
  • Battery powered sensor (replaceable battery)
  • Free calibration certificate
Order Now

Qualification of warehouses and cold rooms

 

Rooms in which pharmaceutical products are stored - in GMP, GDP or GLP environments - must be qualified. Qualification is proof that a room fulfills its intended purpose: Qualification certifies that the storage or cold room is suitable for intended use and that the defined temperature range is uniformly maintained at each storage position.

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From temperature mapping to compliance in two months

Case study on the successful completion of a GMP-compliant temperature mapping in a highly automated Autostore of one of Germany's TOP online pharmacies.

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Warehouse and Cold Room Monitoring Guide

Get the tools to ensure your processes and products are compliant and safe.

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GMP Regulations: Your Product and Process Quality Control Responsibilities

An easy to follow guide to help readers understand GMP.

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Warehouse Qualification

The following short Video series explains you everything you need to know about warehouse qualification.

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EXPERT GUIDANCE

Get Support from our Temperature Monitoring Specialist today!