The industries most dependent on temperature monitoring are those that are strictly regulated to keep human and veterinary products safe. A product sold to be inhaled, ingested, injected, emitted, or absorbed has great potential to either improve or harm the effected body. National and international organizations regulate the manufacturing, storage, and distribution of these products with the ultimate goal of protecting the public’s health.
Top Industries with Strict Temperature Monitoring
- Clinical Research (Trials)
- Treatment/commercialized products
- Genetic engineering
- Molecular analysis
- Chemical assays for the preservative
- Advanced therapy medicinal products (ATMP)
- Gene therapy
- Somatic cell therapy
- Tissue-engineered medicinal products
- Life science for medical practice and agriculture
- Logistics vendors
Under the term “pharmaceuticals”, a variety of materials and products are summarized, such as drugs, medicines, biopharmaceuticals, and active pharmaceutical ingredients (API). Pharmaceuticals, research materials, and human body samples all have sensitive properties, which change with temperature and relative humidity.
Public health is jeopardized when these products are exposed to unfavorable environmental conditions, mainly temperature and humidity. Manufacturers of these products conduct stability testing, which identifies the environmental parameters in which a product maintains efficacy and quality. To ensure and document this stability, environmental monitoring devices, including a temperature sensor and/or a humidity sensor, are utilized during production, transport, and storage.
When it comes to environmental monitoring, these industries share the same challenges. The list below describes their pain points in order of priority.
Pain Point 1: Sterility and Containment
Exposure to environmental conditions outside the tested stability range can degrade products. Degradation and product spoilage is an extreme financial burden on companies. Additionally, legal ramifications and the corresponding public response can easily disrupt, if not destroy, a business. Therefore, the top priority is protecting their products and samples through environmental monitoring and controls.
Humidity causes desterilization, irreversible destabilization, decomposition, disintegration, contamination, and oxidative degradation. When a product is exposed to humidity, it could become sticky or crumble, jeopardizing the production machinery. When utilizing moisture-permeable packaging containers, consideration should be given to the stability of the contents under high humidity conditions.
Similar to humidity, temperature can also negatively affect product quality. Certain temperatures can change chemical properties. Chemical spoilage and physical changes like visible mold growth, changes in colorization, texture, or smell can negatively affect the drug. Certain temperatures foster the growth of microorganisms. Proteins decompose depending on time and temperature — the higher the temperature, the faster they fall apart. Gel turns to liquid at high temperatures. Proteins are also sensitive to water and moisture, which compromises potency and effectiveness, and it jeopardizes chemical stability.
The industries previously mentioned rely heavily on the quality of chemical and biological products, both of which are affected by temperature and humidity. During development and manufacturing, a temperature and humidity sensor is an essential instrument to ensure a product or sample is safe and effective for public use.
Humidity levels directly affect the way water moves throughout a plant (transpiration), how water is absorbed, and the rate of photosynthesis. It also affects the shape and breakage of the plant effecting reproduction.
Biospecimens are any living organism or living cell. The ideal temperature to preserve a sample depends on the specimen type. Every time samples are frozen and thawed, degradation occurs. Typically, slow changes can reduce the rate of degradation. Some samples are stored at temperatures around +1 °C to +27 °C, but the expectation is that the DNA in these samples is often degraded. Samples are sometimes stored in refrigerators or freezers for short-term storage and easy access to use regents like enzymes and antibodies.
Significant Temperature Humidity Ranges
- 60% RH potential for viruses, bacteria, mold, fungi, and mite growth
- +45 °C to +100 °C: heat-loving microorganism growth
- +25 °C to +40 °C: microorganism optimal growth
- +15 °C to +40 °C: microorganism growth
- < +18 °C: microorganism growth decreases
- 0 °C: microorganism growth nearly ceases
- < -18 °C microorganisms may completely cease
- <-80 °C: prevents the degradation of biological molecules
- <−130 °C: metabolic changes cease (ATMPs/cell and gene therapy)
- -150 °C and -190 °C all biological activity is suspended
Temperature and Humidity Correlation
Relative humidity is the percent of water vapor in a volume of air. It is the amount of moisture the air can hold without forming condensation. Industries will measure relative humidity when the products and ingredients are altered by humidity conditions. Because temperature effects relative humidity, both temperature and relative humidity are often monitored and controlled to provide longevity and protect the products. As the temperature increases, relative humidity decreases.
If the temperature significantly drops, the water vapor can overflow in the form of condensation. Increased air pressure during transport systems will affect the dew point of the air within the system, and condensation could occur at higher-than-expected temperatures. Needless to say, if the product is at risk, a temperature-humidity sensor application is necessary for both measurements.
Factors that affect temperature and humidity in a controlled environment include:
- building insulation
- airflow control
- number of openings
- geographic location
- number of personnel
- materials and new product formation
- cleaning cycles
- procedures for material transfers, etc.
- moisture permeable containers for packaging
Building Management Systems (BMS)
These industries cannot rely on conventional BMSs and HVAC systems to control the temperature and humidity because their products require more precise monitoring. Many systems are not validated, therefore, not compliant. The strict regulatory requirements lead companies to depend on other environmental systems and monitoring devices — ones where the primary goal is accuracy, collecting traceable data and ensuring compliance. With a properly calibrated temperature sensor and humidity sensor, companies are able to confidently preserve and extend the shelf life of their products, where otherwise they would be susceptible to microorganism growth.
Pain Point 2: Compliance
There are several motivating factors for industries to prioritize compliance. As mentioned earlier, regulations are enforced to ensure public safety, quality, and efficacy. Checks and balances are always necessary for accountability and to reduce the probability of mistakes. That being said, negative reinforcement is also a motivating factor. Criminal prosecution, fines, and other consequences of violations can be devastating for both individuals and the company.
Product profitability is positive reinforcement. The sooner a treatment is approved, the sooner a treatment can be marketed, and the sooner a patient can receive the treatment. In order to get the treatments approved quickly, a qualified and validated environmental monitoring system must provide data that is easy to find and share with the auditors.
Pain Point 3: Data Integrity and Supply Chain Visibility
Transportation from start to finish includes a lot of moving parts (literally) and several responsible parties. It can be difficult to track the details of a shipment. Industries need a system in place that accurately logs the time, the location, the responsible party, and the environmental conditions throughout the entirety of the supply chain. Ideally, the system will notify someone to address obstacles along the cold chain like temperature excursions before the shipment is damaged.
Simplified End-to-End Cold Chain
The more stringent the requirements for the products, the higher the operational cost, the more value the shipment will be. Compliance can be more difficult when it comes to just-in-time delivery to patients or Direct-to-Patient deliveries. Critical biologics and gene and cell therapies often require complex and time-constrained deliveries.
These cases call for data loggers with real-time monitoring and additional sensors, including ultra-low temperature, geographic location, light, acceleration (movement/tilt), etc. The real-time feature enables remote monitoring in the cloud.
Critical Cold Chain
Pain Point 4: Data Management
The market is flooded with a variety sensors and data loggers. It is challenging to find a cost-effective solution where users can accurately collect data. A data logger is able to pull information from its sensor. Once the information is stored, is the data organized automatically? How customizable is the database? Are there automated analysis and assessment functions? Is the solution compliant with current good manufacturing practice (cGMP) and good distribution practice (GDP) regulations? A good accompanying software's job is to provide an interface where users can easily find and interpret the collected data.
Pain Point 5: Mitigate Risks to Products
The ultimate regret is when a patient is deprived of their expected treatment because of a temperature excursion in the cold chain. Monitoring systems should have a temperature sensor and humidity sensor programmed to identify when the product is out of its acceptable ranges. Some systems notify users via an audible alarm, a light, a phone call, an email notification, or a text message notification. A good alarm system will have more than one way to notify responsible persons who are able to initiate contingency plans. A spoiled product is significant and costly because of the time and materials involved in its development.
Pain Point 6: Scalability
Each of these industries are growing rapidly. Whether they are well-established or a recent startup, the expectation is growth. That being said, companies want to invest in a monitoring system they can continue to use through the addition of one monitoring point or a thousand monitoring points.
Other industries using a temperature sensor and humidity sensor to protect their products
Food for human consumption, for example, is also food for competing microorganisms like bacteria and fungi. If left to their devices, microorganisms rapidly reproduce and create chemicals that are both toxic and unappetizing.
Freezing temperatures almost eliminate these microbes, but their growth increases nearly exponentially as temperatures increase up to 40°C. Therefore, a temperature sensor is an easy way ensure the safety of food products.
We can freeze food to preserve food, and we can refrigerate perishables to slow the bacteria rate of growth. Psychrophilic bacteria lives in temperatures from 0°C to 20°C so refrigeration only extends the shelf life. In addition to low temperature, low water activity protects foods against microorganisms. Needless to say, an environmental monitoring system provides managers the opportunity to prevent food from spoilage.
Fine Art and Archaeology
A temperature and relative humidity sensor can prevent plastics and organic materials rate of deterioration. Heat causes chemical deterioration. Water/humidity exposure, or thermal expansion in inorganic materials, especially metals, can cause materials to change size and shape. For example, metal corrosion, fading, glass decomposition, cracking, splitting, and warping ultimately jeopardizing the strength and integrity of the material. Similar to biologics, fluctuation of temperature and humidity causes stress on materials.
When it comes to preserving artifacts and antiquities, it is helpful to understand that canvas, wood, parchment, and paper have moisture contents that balance with the surrounding humidity. A majority of art and documents archived or displayed in a museum are made of natural materials that are sensitive to environmental conditions. Museums typical regulate the temperature between 18°C to 20°C, to accommodate the comfort of visitors, but a lower temperature would be optimal. A reliable environmental monitoring system should be used to ensure optimal conditions.
An Introduction to Cold Chain Monitoring
What is it? When did it begin?