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During transportation, perishable goods and supplies often face harsh conditions, leading to significant risk, including spoilage of valuable product. It's estimated that 20 percent of pharmaceutical freight is damaged in transit due to improper handling and failure to maintain the correct temperature range.
Without an effective strategy, businesses risk financial loss, compromised product integrity, and eroded customer trust. Real-time monitoring provides immediate alerts, allowing businesses to react before damage occurs.
In the past, cold chain management was reactive and slow, requiring weeks or months to analyze damage and identify causes. Teams would then create new procedures to prevent future issues. Thanks to advancements in technology, suppliers now have complete visibility into their shipments at all times, enabling more efficient logistics.
Real-time monitoring shifts the focus to prevention, using data to spot anomalies and address risks before they escalate. While visual inspections are still valuable, real-time monitoring ensures critical decisions to optimize environmental conditions can be made during transit, to prevent rather than react to temperature excursions.
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What Is Real-Time Monitoring?
Real-time monitoring continuously delivers updated data, allowing for immediate action when temperature excursions arise to maintain regulatory compliance. For example, when transporting samples that require freezer storage, any fluctuation triggers an alert, preventing loss. The data provided by temperature sensors helps spot problems early.
With technologies like IoT, real-time monitoring systems collect and share data automatically, eliminating the need for human intervention.
Real-Time Monitoring Benefits
Real-time monitoring prevents damage and maximizes efficiency by:
- Instant Alerts: Immediate notifications allow for quick action to save products.
- Accuracy: Automated processes reduce human error and provide reliable data.
- Customization: Indicators can be tailored to specific product types.
- Automation: Processes at both sender and recipient locations can be fully automated.
- Reports and Analytics: Automatically generated reports help analyze trends and prevent future issues.
- Asset Location Tracking: Combining temperature, humidity and location data helps logistics providers improve service and reduce waste.
- Data Accessibility: Real-time access to data from anywhere with an internet connection eliminates manual checks.
- Cost Reduction: Analyzing data trends can reduce administrative and operational costs.
What to Look for in a Cold Chain Real-Time Temperature Monitoring System
- Ease of Use: It should be simple to set up and operate, even for non-tech users.
- Battery Life: Long battery life ensures continuous monitoring.
- Storage Capacity: Adequate storage is necessary for tracking shipments over extended periods.
- Wireless Data Transfer: Wireless transmission allows for timely responses and seamless cloud-based integration.
- Package-Level Monitoring: Monitoring each package individually ensures thorough tracking.
- Over-Time Data: Long-term temperature data is essential for decision-making and dispute resolution.
PDF Data Loggers vs. Real-time Data Loggers
Market Authorization Holders (MAHs) of temperature-sensitive biological products must monitor shipments throughout the supply chain. Traditionally, they’ve used PDF data loggers—a cost-effective technology for tracking temperature and documenting shipment conditions.
- Timing of Intervention: Reactive. Deviations are only detected after shipment, with no possibility of proactive action.
- Safety and Reliability: Start and stop timestamps must be manually set, and the data must be retrieved and uploaded manually, increasing the risk of errors.
- Corrective Action & Preventive Action (CAPA): PDF data loggers collect temperature data, but they don’t record the location of deviations, making it difficult to determine where issues occurred.
- Structure and Cost: Available as single-use devices at low cost (under $20 in bulk), PDF loggers can be adapted for various processes but are limited in scope for critical products.
Real-Time Data Loggers
Real-Time PDF Data Loggers
Real-time data loggers offer several advantages.
- Timing of Intervention: Proactive. Logistics service providers (LSPs) receive notifications before deviations happen, minimizing product loss and budget waste.
- Safety and Reliability: Automated processes ensure more accurate data collection, reducing the potential for human error.
- CAPA: Aggregated temperature and position data allow for better analysis, helping to improve cold chain processes and reduce costs.
- Structure and Cost: While more expensive, real-time data loggers require centralized management, offering greater control and insights.
Security
Both PDF and real-time data loggers ensure data security through encryption, safeguarding data integrity. Real-time systems, especially those on public networks, employ additional security measures like IPsec tunnels and MPLS to create secure, quasi-private networks. These devices ensure data is transmitted securely, confirming receipt before disconnecting.
No matter what technology is used to collect temperature data or monitor shipments, some sort of hardware and software will be outside of your direct control. If you work with a device where a computer is used to generate and upload the PDF report, or if you work with a real-time device connecting to the cloud, data is secure through encryption. Therefore, data integrity is assured.
PDF data loggers provide an affordable, flexible solution for non-critical shipments but are reactive and limited in scope. For high-value, temperature-sensitive products, real-time monitoring offers superior visibility and control, ensuring product quality and reducing risk. Many MAHs adopt a mixed approach—using PDF data loggers for less critical products and real-time devices for more sensitive shipments.
Applications of Real-Time Data Loggers
Cell and Gene Therapy and High Risk Shipments: When shipping high-value, sensitive biopharmaceuticals, maintaining correct temperature range is critical. Temperature sensor data allows for immediate interventions to prevent product loss.
Requirements for Real-Time Tracker:
- Compliance in temperature monitoring
- Zero deviation due to real-time intervention
- Combine real-time device with traditional PDF USB data logger for less critical products/shipments
Asset Location Tracking and Compliance: LSPs owning and operating fleets of cold chain equipment (containers, multi-use boxes, trucks & vans) must provide compliant temperature monitoring. Traditionally, LSPs used logistics trackers to monitor locations of shipments along with temperature monitoring data loggers. These are put in place by the shipper or sometimes offered as an add-on. Smart LSPs have combined the functionalities into one device, increasing operational efficiencies, and saving cost.
Requirements for a Real-Time Tracker:
- Monitor temperature, position, and other parameters (e.g., heat, light, tilt, humidity)
- GAMP® 5 validation
- Battery life of >1 year
- Capable of integrating data into third-party asset management solutions
Complex Global Supply Chain: Many large pharmaceutical companies have a mixture of products, shipping modes, and packaging methods. Shifting all their monitoring devices from PDF to real-time is not an option due to cost and complexity. They want a temperature-monitoring database, which offers all options in parallel: real-time trackers, PDF USB data loggers, and low-cost box-level indicators.
Requirements for Real-Time Tracker:
- Real-time capabilities with end-to-end global visibility and control
- Compliance in temperature monitoring
- Combine real-time device with traditional PDF data logger for less critical products/shipments and box-level indicators
- Simple and intuitive
Clinical Supply Chain: Clinical trials are often shipped to remote destinations where the responsibility for the product is not handed-over to a customer or recipient, but it remains with the product owner. In such situations, data loggers with a battery-life of up to 2 years are used to monitor the shipment, release the product at destination, and follow the product into the local storage or refrigerator. The data archive and alarming must be under central control.
Requirements for Real-Time Tracker:
- Monitor products during shipments
- Safe and easy release at destination
- Follow the product into remote warehouses and refrigerators
- Keep on monitoring the product during storage at remote site
An Integrated Approach to Real-Time Monitoring
Installing a reliable monitoring system alone won’t suffice. A more comprehensive approach involves the following:
Education and Regulation
Before a product enters the supply chain, there should be a designated logistics team and clearly defined standard operating procedures. Additionally, management should facilitate thorough training for the team.
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