All aspects of the manufacturing, storage and distribution processes of pharmaceuticals are affected very greatly by temperature. Any deviation in temperature can negatively affect the quality, potency and safety of the product. Temperature sensors are extensively used in clean rooms, warehouse and cold chain environments as well as manufacturing equipment to help make sure that the temperature is held to very strict environmental conditions.
The temperature sensors monitor and record the temperature of your product continuously, ensuring compliance with Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP). This article will provide information about these sensors, explain how they work and discuss what features to look for when selecting a sensor for use in your facility.
Temperature sensors will confirm that the temperature in all equipment and surrounding areas stay within their validated temp. limits defined by either the product specifications or the regulatory guidelines.
Temperature monitoring is important to:
1) Ensure shelf life of products and product stability
2) Ensure there is consistency in the manufacturing process
3) Ensure compliance with FDA, EMA and WHO regulations
4) Allow for traceability and integrity of data during audits
Temperature monitoring with appropriate temperature sensing devices, reduces risks as well as waste and ensure patient safety.
Here are some examples of temperature sensors:
- Wide range of measurement between -200 degrees C to 1700 degrees C.
- Fast response time.
- Can be used in high heat areas like sterilizers and driers.
- Requires cold junction compensation.
- Very accurate with great repeatability.
- Limited measurement capabilities (-200 degrees C to +600 degrees C).
- Has great long-term stability with low drift.
- Commonly found in cleanrooms, incubators and for process control.
- Very high sensitivity and quick response time.
- Use of thermistors is limited to ranges of -50 to +150 degrees C.
- Can be used to accurately control localized areas of cooling (such as in refrigerators and laboratory equipment).
Some of the features of infrared sensors include:
- Suitable for use on immovable or difficult-to-reach surfaces.
- Instantaneous results.
- Commonly used to measure temperature in non-contact applications'; such examples include using infrared sensors for monitoring movement in the conveyor system or monitoring temperatures in sterile environments.
Some of the features of semiconductor-based temperature sensors include:
- Compact, affordable and reliable.
- Widely used in electronic equipment as well as in measuring temperatures in outdoor environments.
- WHO Technical Report 961, Annex 9 (mappings).
- Good Practice Guide to Thermal Mapping issued by the ISPE.
- FDA 21 CFR Part 211 (storage/distribution).
For example, if you put the product in an HVAC system or a Clean Room or a Transport Vehicle, then, you will be able to continue to monitor and track the product’s temperature throughout your Logistic Management and Building Management System (BMS) and/or validate software applications to record temperatures continuously for all areas within the facility.
1. Wireless Sensors (IoT) - Allow for real-time tracking and alerts from a distance;
2. Digital RTDs - Give direct digital output for easy calibration and accuracy;
3. AI predictive monitoring - Helps predict equipment failure through the analysis of trend data.
4. Blockchain Integration - Creates tamper-proof records of temperature in the cold chain logistics industry.
These technologies will drastically change how we manage compliance and improve the transparency of our data.
Calibration consists of the following steps (at a minimum):
1. Compare the reading of a temperature sensor against a calibrated reference standard.
2. Document and correct any deviation found.
3. Maintain all temperature sensor calibration information in properly controlled logs.
4. Create re-calibration schedules for all temperature sensors (almost always annually).
The temperature monitoring system (all sensors, data loggers and temperature monitoring software) must be validated to ensure that it will work properly during actual use.
- Assurance of compliance with regulations and standards.
- Assurance of safety for patients.
Temperature Sensors will provide accurate temperature control, continuously. Thus, it is imperative for all pharmaceutical professionals to understand the different types of temperature sensing devices — including their operating principles (how they work) as well as their main features and benefits.
As digital and IoT-based technologies become increasingly integrated into pharmaceutical manufacturing and distribution, the use of temperature sensors will continue to evolve to become more precise, fully automated and ready to be audited. This will make Temperature Sensors one of the most important aspects of today’s pharmaceutical industry.
What are Temperature Sensors?
The temperature sensor is a piece of gear that detects heat energy emitted by an object and turns it into a measurable signal. Temperature sensors are necessary in the pharmaceutical industry to maintain proper conditions for the manufacturing/testing/storage of temperature-sensitive materials (vaccines, injection medications and biological formulas).Temperature sensors will confirm that the temperature in all equipment and surrounding areas stay within their validated temp. limits defined by either the product specifications or the regulatory guidelines.
Importance of Temperature Monitoring in Pharmaceuticals
Temp-sensitive medications, biologics and reagents may be degraded when stored at conditions that are outside of the stated limits of storage. For example, vaccines that have been stored outside of the required ranges, may lose their potency. Aps (active pharmaceutical ingredients) may undergo undesired chemical reactions as well.Temperature monitoring is important to:
1) Ensure shelf life of products and product stability
2) Ensure there is consistency in the manufacturing process
3) Ensure compliance with FDA, EMA and WHO regulations
4) Allow for traceability and integrity of data during audits
Temperature monitoring with appropriate temperature sensing devices, reduces risks as well as waste and ensure patient safety.
Working Principle of Temperature Sensors
Temperature sensors are devices used to measure temperature by way of their characteristics changing when heat or cold is applied. They can be electrical resistance, voltage or current changes which will then provide a temperature reading.Here are some examples of temperature sensors:
- Thermocouples produce a voltage output based on the difference of two different metals.
- RTD's (Resistance Temperature Detector) measure the resistive change in the metal conductors.
- Thermistors use the semi-expression characteristics of semiconductors to change their resistive value based on that semiconductor's temperature.
- Infrared sensors can determine the temperature of any surface without making contact by measuring the radiation emitted from that surface.
Types of Temperature Sensors
In the pharmaceutical have various kinds of temperature sensors. These sensors are used based on your process, temp ranges, accuracy and how fast you need them.1. Thermocouples
They are one of the most popular sensors. They have two different metals hooked on the end that produces a voltage proportional to their temperature difference, when the metals are heated or cooled.- Wide range of measurement between -200 degrees C to 1700 degrees C.
- Fast response time.
- Can be used in high heat areas like sterilizers and driers.
- Requires cold junction compensation.
2. Resistance Temperature Detectors (RTDs)
RTDs work by measuring the change in resistance as the temperature changes. The Pt100 sensor is the most common RTD and uses platinum for its element.- Very accurate with great repeatability.
- Limited measurement capabilities (-200 degrees C to +600 degrees C).
- Has great long-term stability with low drift.
- Commonly found in cleanrooms, incubators and for process control.
3. Thermistors
Thermistors are semiconductor materials that provide an extremely sensitive and fast-responding means of measuring.- Very high sensitivity and quick response time.
- Use of thermistors is limited to ranges of -50 to +150 degrees C.
- Can be used to accurately control localized areas of cooling (such as in refrigerators and laboratory equipment).
4. Infrared Sensor Technology
Infrared sensors detect heated surfaces through non-contact infrared radiation measurement rather than touching them directly.Some of the features of infrared sensors include:
- Suitable for use on immovable or difficult-to-reach surfaces.
- Instantaneous results.
- Commonly used to measure temperature in non-contact applications'; such examples include using infrared sensors for monitoring movement in the conveyor system or monitoring temperatures in sterile environments.
5. Semiconductor-Based Temperature Sensors
Semiconductor-based temperature sensors are integrated circuits (IC) that produce a voltage or current according to how hot or cold something is (the output will be proportional to the temperature).Some of the features of semiconductor-based temperature sensors include:
- Compact, affordable and reliable.
- Widely used in electronic equipment as well as in measuring temperatures in outdoor environments.
Key Features to Look for in Temperature Sensors
There are a number of performance criteria that have to be considered before selecting the best temperature sensing device for use in your pharmaceutical manufacturing environment. The main attributes to look for are as follows:1. Accuracy
The first and most critical performance characteristic in a pharmaceutical environment is accuracy; in fact, even a deviation of just 0.1°C from the desired set-point temperature may affect product quality. The most accurate type of sensor available is RTDs (±0.1°C). The next best option is Thermocouple Sensors, which range from ±0.5°C to ±1.0°C accuracy.2. Stability & Repeatability
Temperature sensing devices should be stable and repeatable with respect to calibration and provide consistent readings over time. Platinum RTDs are far superior when it comes to overall stability when compared to thermistors and thermocouples.3. Temperature Range
Select a sensor that is capable of measuring temperatures within a range that is specified for its intended application. The following temperature ranges are common to pharmaceutical applications: - Cold storage of products: -20 to +8°C - Cleanroom environments: 18 to 25°C - Sterilizers: up to +121°C4. Response Time
The speed by which the temperature sensing device will respond to changes in temperature is critical when thermometer or freeze-drying processes are dynamic/repeatable processes.5. Calibration Capability
Temperature sensing devices must have the ability to be easily calibrated to standard reference conditions. Calibration of a temperature sensor will allow you to provide traceability/timely records of compliance to the National Institute of Standards and Technology (NIST) or equivalent standards.6. Environmental Considerations
When selecting sensors, it's important to ensure they are moisture, vibration and chemical resistant; in addition, for cleaning purposes and for cleaning purposes, use sensors made from stainless steel and Teflon for use in a clean room7. Connectivity/Logging
Sensors today usually have digital interfaces (such as RS-485, Modbus or wireless) for real-time data collection. With data logging functionality, this will satisfy both the 21 CFR Part 11 requirements for electronic records.8. Longevity and Maintenance
Consider selecting sensors that can last for an extended period with little maintenance. For example, sensors that have a durable/protected probe and/or housing may be able to withstand extreme environments.9. Regulatory Compliance
In order to be used within pharmacies, the temperature sensor must comply with GMP, all GDP requirements and associated quality system regulations. These include:- WHO Technical Report 961, Annex 9 (mappings).
- Good Practice Guide to Thermal Mapping issued by the ISPE.
- FDA 21 CFR Part 211 (storage/distribution).
Applications of Temperature Sensors in Pharmaceuticals
Sensors measuring temperature are introduced at all stages of a product's life cycle, whether it is being manufactured, shipped or stored. Within zone areas, temperature sensors can also be used in clean room settings to ensure you maintain the correct environmental conditions for the products you are working in Clean Rooms, HVAC Systems, Refrigerators/Freezers, Autoclaves and Transport Vehicles.For example, if you put the product in an HVAC system or a Clean Room or a Transport Vehicle, then, you will be able to continue to monitor and track the product’s temperature throughout your Logistic Management and Building Management System (BMS) and/or validate software applications to record temperatures continuously for all areas within the facility.
Emerging Technologies in Temperature Sensing
Modern temperature sensors have become increasingly sophisticated and dependable as a result of the rise of digital technology.1. Wireless Sensors (IoT) - Allow for real-time tracking and alerts from a distance;
2. Digital RTDs - Give direct digital output for easy calibration and accuracy;
3. AI predictive monitoring - Helps predict equipment failure through the analysis of trend data.
4. Blockchain Integration - Creates tamper-proof records of temperature in the cold chain logistics industry.
These technologies will drastically change how we manage compliance and improve the transparency of our data.
Calibration and Validation of Temperature Sensors
Regulatory bodies mandate routine calibration of all temperature sensing devices. Calibration provides the assurance of accurate temperature readings, as well as being able to trace back their accuracy to the national standard.Calibration consists of the following steps (at a minimum):
1. Compare the reading of a temperature sensor against a calibrated reference standard.
2. Document and correct any deviation found.
3. Maintain all temperature sensor calibration information in properly controlled logs.
4. Create re-calibration schedules for all temperature sensors (almost always annually).
The temperature monitoring system (all sensors, data loggers and temperature monitoring software) must be validated to ensure that it will work properly during actual use.
Temperature Sensors are components that provide:
- Assurance of product integrity. - Assurance of compliance with regulations and standards.
- Assurance of safety for patients.
Temperature Sensors will provide accurate temperature control, continuously. Thus, it is imperative for all pharmaceutical professionals to understand the different types of temperature sensing devices — including their operating principles (how they work) as well as their main features and benefits.
As digital and IoT-based technologies become increasingly integrated into pharmaceutical manufacturing and distribution, the use of temperature sensors will continue to evolve to become more precise, fully automated and ready to be audited. This will make Temperature Sensors one of the most important aspects of today’s pharmaceutical industry.
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