A product sold to be inhaled, ingested, injected, emitted, or absorbed has great potential to either improve or disturb the working-condition of the effected body. National and international organizations regulate the sale of these products with the ultimate goal of protecting the public’s health.
Public health can be jeopardized when products are exposed to unfavorable environmental conditions, mainly temperature and humidity.
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, temperature monitoring is an easy way to monitor the safety of food products.
Like food, pharmaceutical products and drugs are also threatened by the competing microorganisms. Microbial toxins (like E. coli) and microbial metabolites are harmful to humans. Additionally, chemical spoilage and physical changes like visible mold growth, changes in colorization, texture, or smell can negatively affect the drug.
Under the term “pharmaceuticals”, all kind of materials and products are summarized such as drugs, medicines, bio-pharmaceuticals, active pharmaceutical ingredients (API), research materials, human body samples, or even medical devices. What they all have in common is that their properties and therefore their quality change with temperature—for example:
- Proteins decompose depending on time and temperature—the higher the temperature, the faster they fall apart
- Gel turns to liquid at high temperatures
- Therefore losing stability budget might be harmful to patient safety.
Temperature and relative humidity affects plastic's and organic material's 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 a museum’s or library’s documents and art 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.
We can freeze food to preserve food, and we can refrigerate perishables to slow the bacteria rate of growth. Psychrophiles 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.
Pharmaceutical companies preserve and extend the shelf life of drugs by regulating temperature and humidity. Unfavorable environmental exposure can degrade pharma products, causing loss of efficacy and quality.
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 are often degraded. Samples are sometimes stored in refrigerators or freezers for short-term storage and (easy access to use regents like enzymes and antibodies). Ultro-low temperatures (-80 °C) prevent the degradation of biological molecules, but all biological activity is suspended at cryogenic temperatures between -150 °C and -190 °C.
An Introduction to Cold Chain Monitoring
What is it? When did it begin?