Sigma-Tau Pharma Improves Temperature Management With Wireless Tech
Maintaining the integrity of pharmaceuticals throughout the distribution chain is paramount. Exposure to temperatures or humidity outside of the specified range during storage or transport can affect their quality, efficacy, and expiration period. For companies like Sigma-Tau Pharma, a leading international manufacturer of pharmaceuticals, adhering to Good Distribution Practice (GDP) regulations is not just a requirement – it’s an essential part of their operations.
Italy-based Sigma-Tau Pharma AG recognized the critical need for accurate and reliable temperature and humidity monitoring within their distribution network. Traditional methods proved inadequate, failing to provide the real-time data and flexibility required by modern quality assurance standards such as the Swiss AMBV ordinance. To address this challenge, Sigma-Tau implemented a robust solution utilizing MSR145WD wireless data loggers supplied by MSR Electronics GmbH. These compact devices continuously monitor and record temperature and humidity levels, generating a comprehensive dataset crucial for maintaining product quality and ensuring compliance with stringent GDP guidelines. These thumb-sized data loggers can store up to 1 million data points in non-volatile memory and operate on a rechargeable internal battery allowing several months of continuous operation.
The MSR145WD loggers offer several key advantages:
- Uncompromising Accuracy: Precisely measure and record temperature and humidity levels, ensuring data integrity and reliability.
- Extensive Data Storage: Capture and store a significant volume of data, providing a comprehensive historical record of storage conditions.
- Bluetooth Low Energy (BLE) Wireless Communications: Connect read-out data using a smartphone or tablet from up to 30 feet away to simplify data retrieval.
- Seamless Connectivity: Integrate seamlessly with the MSR SmartCloud, enabling remote data access, real-time monitoring, and automated alerts.
- User-Friendly Design: Compact and easy to deploy, with intuitive user interfaces for data retrieval and analysis.
By leveraging the capabilities of these advanced data loggers, Sigma-Tau has achieved several key benefits:
- Enhanced Product Quality: Consistent monitoring ensures optimal storage conditions, safeguarding the quality and efficacy of pharmaceuticals throughout the distribution chain.
- Streamlined Compliance: The system provides a robust audit trail, facilitating compliance with GDP regulations and minimizing the risk of non-compliance.
- Improved Efficiency: Automated data collection and analysis streamline workflows, freeing up valuable time for other critical tasks.
- Proactive Issue Resolution: Real-time monitoring and automated alerts enable the proactive identification and resolution of potential storage issues, minimizing the risk of product degradation.
- Data-Driven Decision Making: The comprehensive data collected provides valuable insights into storage conditions, enabling data-driven decisions to optimize distribution processes and improve overall operational efficiency.
The implementation of MSR145WD data loggers has proven to be a significant success for Sigma-Tau Pharma. By embracing this innovative technology, the company has strengthened its commitment to quality, enhanced its compliance posture, and gained a competitive edge in the pharmaceutical market.
This Application Note has been adapted from an article written by MSR Electronics GmbH. MSR is the manufacturer of the MSR145WD, the Bluetooth Low Energy (BLE) wireless monitoring solution ideal for life science applications. Sigma-Tau Pharma is now Leadiant Biosciences as of 2017.
For more information on the MSR145WD, or to find the ideal solution for your application-specific needs, contact a CAS DataLogger Application Specialist at (800) 956-4437 or request more information.