Introduction
Ensuring the high quality of pharmaceuticals is very important in the pharmaceutical industry. The precise control of the real-time temperature in pharmaceutical storage is paramount due to the sensitivity of many drugs to temperature fluctuations. Deviations from recommended storage conditions can result in chemical degradation, diminishing the efficacy or rendering drugs inactive. High temperatures, for instance, may prompt molecular alterations, leading to a loss of therapeutic activity. Additionally, temperature variations can induce physical changes such as crystallization or separation, impacting the appearance and consistency of pharmaceuticals.
This case study delves into how the implementation of SenzMate POLAR in a prominent Sri Lankan pharmaceutical warehousing company transformed real-time temperature monitoring, contributing significantly to maintaining optimal storage conditions and upholding industry standards.
Business Case
Temperature-sensitive drugs traverse various stages of the supply chain, underscoring the importance of maintaining proper temperatures from manufacturing to end-user distribution. Regulatory bodies like the U.S. FDA and the European Medicines Agency have instituted guidelines to uphold the integrity of pharmaceuticals during storage and transportation.
The above pharmaceutical warehousing company, adhering to these regulations and ethical standards in the pharmaceutical supply chain, recognized the need for continuous real-time temperature monitoring. Identifying disparities in temperature across different locations within their warehouses, they observed that areas like the entrance to the warehouse had slightly higher temperatures compared to the middle and back of the facility. Understanding the potential impact on pharmaceutical standards and quality, they sought a solution to monitor temperatures comprehensively.
Stepping into the spotlight, SenzMate POLAR - the chosen system to fulfill this requirement. By implementing continuous real-time temperature monitoring at various points in the warehouses, this pharmaceutical company was able to ensure consistent and optimal storage conditions, aligning with regulatory requirements and maintaining the highest standards of pharmaceutical quality and safety.
Solution
POLAR played a pivotal role in transforming the temperature monitoring practices of the pharmaceutical warehouse mentioned above. This innovative system effectively tracked real-time temperature fluctuations across different locations within the warehouses, providing the responsible staff with a comprehensive interface for accurate and efficient oversight.
Designed with a high level of responsiveness, POLAR is ready for any deviations in temperature or humidity levels within the cold warehouses. If a condition is breached, whether in terms of temperature or humidity, the system promptly triggers notifications via SMS and app alerts. The beauty of the POLAR system lies in its ability to respond to the maintenance crew so that they can swiftly and appropriately address any issues, ensuring that the storage conditions of pharmaceutical goods remain within the required parameters. In essence, POLAR emerges as a comprehensive solution, providing robust monitoring and maintenance capabilities for cold rooms storing pharmaceuticals. This contributes significantly to upholding the quality and safety standards of the stored pharmaceuticals, ultimately enhancing the overall integrity of the pharmaceutical supply chain.
Action Taken
POLAR underwent testing in two different types of warehouses and in an ice box in the above company. In the first warehouse, equipped with two large fans, a POLAR device was installed at the entrance to track real-time temperature fluctuations, while additional devices were strategically placed in various locations throughout the warehouse. The same setup was arranged in the slightly larger second warehouse also.
Ice boxes played a vital role in the supply chain's distribution phase, introduced as the second assessment six months after Senzmate POLAR's initial evaluation in the company. These boxes stored pharmaceuticals with various ice packs, keeping temperatures between 4 to 8 degrees Celsius. To assess different ice pack types' durability during distribution and safeguard pharmaceutical quality, each box had a dedicated POLAR device. This step also ensured the company's ISO-related quality certification.
POLAR real-time monitoring devices are connected with temperature and humidity sensors. Once these sensors and devices are installed, the POLAR system kicks into action, monitoring the critical environment of the warehouses and ice boxes. The system captures data around 24/7 hours, logging any changes in temperature and humidity within the associated devices. This continuous monitoring ensures that the conditions crucial for preserving the quality of pharmaceuticals are consistently maintained and stored on the cloud platform.
Results
Adding SenzMate POLAR to the pharmaceutical supply chain made things better. It gives real-time updates on temperature changes and sends alerts, making sure medicines are stored in the right conditions in both the warehouses and ice boxes.
The easy-to-use dashboard with graphs helped the maintenance team see and share room data during storage and distribution. This way, they could spot and fix any potential issues before they became a big problem. SenzMate POLAR not only keeps medicines safe but also makes the whole storage and distribution process work more smoothly.