Introduction
The pharmaceutical industry consists of an entangled web of research, manufacturing, and distribution. Each step is crucial to ensure the efficacy and safety of medicines when reaching the bedside. A key factor, often overlooked, is temperature control during the storage and transport of pharmaceuticals.
Known as ‘temperature excursions,’ fluctuations in temperature can lead to severe degradation of medicines, impacting their potency and safety. This challenge is not restricted to extreme conditions alone. Even slight deviations, both hot and cold, from a pharmaceutical’s ideal storage temperature can have critical implications.
According to industry estimates, the biopharma sector alone loses about USD35 billion annually due to temperature-related issues. Moreover, the problem is not just economical, as pharmaceuticals that have been exposed to improper conditions may not provide the intended therapeutic benefits or, even worse, cause adverse reactions.
What is Thermal Mapping?
Temperature mapping is the systematic measurement and analysis of temperature distribution within a designated area. It is critical in maintaining environmental control, facilitating a thorough understanding of temperature variations and hot or cold spots in a specific space. This in-depth analysis enables people to regulate and optimize conditions within that area.
Temperature mapping can be performed in a myriad of spaces and on various pieces of equipment. For instance, cold storage units like refrigerators and freezers that are used to store temperature-sensitive pharmaceuticals, vaccines, and biological samples are prime candidates for temperature mapping. These units must maintain a stable environment to preserve the integrity of the stored products, and mapping can identify any problematic zones that may compromise this stability.
Similarly, temperature-controlled transport vehicles, such as refrigerated trucks and shipping containers, often undergo temperature mapping. These vehicles are responsible for transporting sensitive products under controlled conditions over long distances. Mapping ensures the entire cargo area maintains the required temperature, thus preserving the quality and effectiveness of the transported goods.
In most cases, the distribution chain involves multiple storage and transit locations, including warehouses, airports, and docks, as well as various modes of transportation, such as aircraft, ships, and trucks. Each of these locations and transportation methods has its unique temperature control challenges and requirements that must be taken into account to ensure that the products remain within the recommended temperature range.
Let’s see how thermal mapping can help you with a real-world example
Consider this real-world scenario: a pharmaceutical company that manufactures a temperature-sensitive vaccine. For the vaccine to retain its potency and safety, it must be stored within a specific temperature range of 2°C and 8°C. The company utilizes a spacious cold room to keep these vaccines safe before they are distributed.
At some point, numerous healthcare providers began raising concerns about some batches of the vaccine that appeared to have lost their effectiveness. Responding promptly, the company initiated a recall of the affected batches to mitigate any further issues.
Meanwhile, the Quality Assurance team embarked on an investigation to identify the root of the problem. After various attempts and hypotheses, the team discerned that the issues were tied specifically to certain batches that had been stored in the cold room.
In order to confirm this hypothesis, the company decided to carry out a temperature mapping exercise. Temperature sensors were strategically placed throughout the cold room, monitoring any variation over a specified period. The collected data revealed a compelling anomaly: while the majority of the cold room maintained the required temperature range, there were significant temperature spikes in some areas, particularly where the vaccine boxes were densely stacked.
Upon closer examination, it became apparent that the dense stacking of vaccines was impeding proper airflow, leading to pockets of warmer air within these compact areas. Armed with this newfound knowledge, the company adjusted its storage practices to ensure that the vaccines were not packed too closely, allowing adequate room for proper cold air circulation. In addition, they started regular temperature mapping exercises to keep a close eye on the temperature distribution within the room.
With this newfound insight, the company modifies its storage practices, ensuring that vaccines are not stacked too closely and that there is sufficient room for proper cold air circulation. They also implement regular temperature mapping exercises to monitor the temperature distribution within the room continuously.
Despite solving the problem as promptly as possible, the company had already received significant damage. They lost the trust of numerous clients due to the compromised vaccine quality, and their reputation within the healthcare sector took a substantial hit. Moreover, a large amount of vaccine, rendered unusable because of improper temperature control, was wasted.
The troubling sequence of events that unfolded could have been avoided entirely if the company had incorporated regular temperature mapping from the onset. Such a proactive measure would have highlighted the air circulation issues, allowing the company to adjust its storage practices early on, thus averting the cascade of adverse outcomes. This example accentuates the critical role that temperature mapping can play in not only preserving product quality but also in maintaining client trust, safeguarding company reputation, and mitigating unnecessary product wastage in the pharmaceutical industry.
Conclusion
In reflection, the story of this pharmaceutical company serves as a potent lesson about the hidden risks that could be lurking within the confines of your own cold storage units or transport vehicles. Are there any unseen ‘hot spots’ or poorly ventilated corners that may be compromising the potency of your stored pharmaceuticals, vaccines, or biological samples? Do your transport vehicles provide a uniform temperature across all regions, or are there zones experiencing undesirable temperature excursions?
As highlighted in this story, temperature mapping can shine a light on these invisible threats before they manifest into tangible problems. It could be the key to preventing the loss of product effectiveness, financial losses, client trust, and company reputation.
Curious to learn more about practical strategies based on real-world examples to transform your perspective on temperature mapping data? Join our highly anticipated live webinar, where we unleash the hidden potential within your temperature mapping reports!
With a dedication to serving the pharmaceutical industry, Qualistery specializes in hosting educational webinars that support both professionals within the pharma sector and service providers. Our commitment lies in empowering businesses to maximize their impact through engaging virtual events and strategic webinar solutions.
