Monitoring of Cold Chains

Pharmaceutical and cosmeceutical products as well as food and feed products are temperature sensitive (to both heat and cold) and need to be maintained within a narrow temperature range to ensure their quality. The temperature ranges will depend on the product and its ingredients/composition. The products are manufactured, stored, possibly shipped and then again stored before the end user uses/consumes the product: this is called the supply chain.

A cold chain is a temperature controlled supply chain. An unbroken cold chain is an uninterrupted series of storage and distribution activities which maintain a given temperature range. In the most critical of cases, if the cold chain is broken, the product if used/consumed, may put someone's life in danger. As of such when the cold chain is broken, non-compliances occur.

There are three main points to each and every cold chain:

  1. Storage (warehouses, shops, fridges, freezers…) and transport equipment (trains, lorries, airplanes…)
  2. Trained personnel
  3. Management procedures

The Rotronic Monitoring System offers a range of products to ensure an uninterrupted temperature monitoring of the cold chain. If the first stage a proactive alarm (warning) can be set, here the users can carry out proactive measures so that the temperature remains within limits. The second stage would be an alarm, stating that the cold chain has been broken. The warnings and alarms can be send vie E-Mail, SMS and telephone call to ensure that the correct people have access to the correct information at the right time.

The current Rotronic product portfolio, used in both the food and pharmaceutical industries, covers various temperature ranges and tolerances. Additional environment parameters such as carbon dioxide, oxygen and relative humidity can also be monitored with RMS (FDA CFR 21 Part 11 & EU ANNEX 11 compliant).

Regulations, guidelines and standard are in place to ensure that products that are non-compliant do not reach the market.

TypeTemperature (°C)Medium examplesApplication examples
Cyrogenic -196 Liquid nitrogen Various
Cyrogenic 80 Dry ice Various
Frozen 30…-40 -- Frozen plasma
Frozen -20 Air Certain vaccines, API studies
Fridge 2…6 Air Red blood cells
Fridge 2…8 Air Storage of vaccines for a short period of time
Cool 8…15 Air Various
Room temperature 15…25 Air Various
Ambient temperature 15…30 Air MKT of 25°C maximum!
Ambient temperature 20…24 Air Platelets
Culture 20…35 -- Detection of fungi, bacteria, yeast, mould…
Accelerated stability testing bis zu 50-60 Air Drug stability testing
Stress test 60, 70, 80, 90, 100 -- Above the accelerated testing temperature with over 75%rh.
Sterilisation 180 -- Climatic chambers

 

Based upon the product and the packaging, relative humidity is also a key factor to monitor:

TypeRelative humidityMedium examplesApplication examples
Protect from moisture < 60 %rh -- Various

 

Recommended products

  1. RMS T10-0001

    The T10 temperature sensors are NTC (Negative Temperature Coefficient) thermistors, meaning that the resistance of the NTC decreases with increasing temperature.

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  2. RMS T10-0002

    The T10 temperature sensors are NTC (Negative Temperature Coefficient) thermistors, meaning that the resistance of the NTC decreases with increasing temperature. The T10 temperature sensors are compatible with the RMS-MLOG-T10-868/915 data loggers.

    Learn More
  3. RMS T10-0003

    The T10 temperature sensors are NTC (Negative Temperature Coefficient) thermistors, meaning that the resistance of the NTC decreases with increasing temperature. The T10 temperature sensors are compatible with the RMS-MLOG-T10-868/915 data loggers.

    Learn More
  4. RMS T10-0004

    The T10 temperature sensors are NTC (Negative Temperature Coefficient) thermistors, meaning that the resistance of the NTC decreases with increasing temperature. The T10 temperature sensors are compatible with the RMS-MLOG-T10-868/915 data loggers.

    Learn More
  5. RMS T10-0005

    The T10 temperature sensors are NTC (Negative Temperature Coefficient) thermistors, meaning that the resistance of the NTC decreases with increasing temperature.

    Learn More
  6. RMS T10-0006

    The T10 temperature sensors are NTC (Negative Temperature Coefficient) thermistors, meaning that the resistance of the NTC decreases with increasing temperature. The T10 temperature sensors are compatible with the RMS-MLOG-T10-868/915 data loggers.

    Learn More
  7. RMS T30-0001

    The T30 temperature sensors are resistance thermometers (Pt100 = positive measurement resistance), meaning that the resistance increases with increasing temperature. The sensors are compatible with the RMSLOG- T30-L, RMS-LOG-T30-868 and RMS-LOG-T30-915 data loggers.

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  8. RMS T30-0003

    The T30 temperature sensors are resistance thermometers (Pt100 = positive measurement resistance), meaning that the resistance increases with increasing temperature. The sensors are compatible with the RMSLOG- T30-L, RMS-LOG-T30-868 and RMS-LOG-T30-915 data loggers.

    Learn More
  9. RMS T30-0006

    The T30 temperature sensors are resistance thermometers (Pt100 = positive measurement resistance), meaning that the resistance increases with increasing temperature. The sensors are compatible with the RMSLOG- T30-L, RMS-LOG-T30-868 and RMS-LOG-T30-915 data loggers.

    Learn More
  10. RMS-LOG-T30-L - Data Logger

    The RMS-LOG-T30 is a data logger with two integrated analog-to-digital converters, to which two PT100 sensors can be connected for high-precision temperature measurement.

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