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Pharma products are sensitive to the slightest temperature and environmental condition changes. Incorrect handling, exposure, and temperature excursions during transport and storage can ruin the items’ quality and make them ineffective and unsafe for patients.
The solution? Implement pharma cold chain monitoring best practices, which start with gaining an understanding of temperature-controlled logistics considerations, to help track and maintain drug safety and quality across the cold chain.
This guide covers some of the best practices in pharma cold chain monitoring and helps streamline your operations.
The importance of proper cold chain monitoring for pharma items
Good pharma cold chain monitoring and distribution practices are critical to maintaining drug safety and quality as your items move across the supply chain. Implementing these best practices can also help you comply with regulatory bodies such as the Food and Drug Administration (FDA) and World Health Organization (WHO).
However, maintaining the medicine’s quality throughout the cold chain can be challenging, since various pharma products can have specific storage conditions and indicated shelf life. Transferring and storing syrups, tablets, and injectables in various dosage forms requires distinct environmental conditions.
For instance, vaccines generally require storage at temperatures between two to eight degrees celsius. As such, you’ll need to ensure proper handling and monitoring across the cold chain to prevent damaging and compromising the items’ quality and safety.
Top pharma cold chain monitoring tips
Efficient and comprehensive cold chain monitoring can help protect your pharma products, the customers and patients, and, in turn, your business.
Below are tried and tested tips to achieve a more effective and efficient pharma cold chain monitoring process.
1. Protect pharma products in transit
Delays, human error, equipment malfunctions, and exposure during long wait times can cause temperature excursions for pharma products requiring refrigeration or freezing (or protection from freezing). The solution? Protect your pharma products in transit using wireless sensors to detect and report temperature excursions automatically.
Wireless Industrial Internet of Things (IIoT) sensors are small, cost-effective devices you can easily deploy in shipping containers, vehicles, and product packaging at each stage of the transit.
Logistics professionals can send data from these sensors to the cloud on an intermittent schedule, allowing managers to monitor shipment temperatures anytime, anywhere. It eliminates waiting for local servers to update your databases using input from wired, non-cloud systems.
You’ll get low latency monitoring features, including alerts when equipment or your packages deviate from the required temperatures. This allows logistics managers to tag and remove compromised pharma products before reaching customers and patients.
Advanced cold chain monitoring systems can also combine temperature sensors with location trackers to send automated alerts pinpointing problem areas or links in the cold chain. This allows quick adjustments to prevent future issues that compromise and damage your pharma products. It also reduces instances of product recalls while protecting the patients’ health.
2. Monitor and control humidity levels
Besides monitoring your pharma products’ temperatures at all stages of the cold chain, it’s also critical to track the humidity levels to keep the items safe and sound. High humidity can cause pharma drugs to absorb moisture, which can happen at any stage of the cold chain, from final packing and shipment to storage.
This can cause degraded quality in certain medications, and they can lose their efficacy, leading your business to lose contracts and sustain significant reputation damage.
Tracking humidity levels properly can also help keep your pharma products stable through their expiration dates. This helps prevent mold from growing on the packaging, especially when medications are exposed to highly humid environments.
Leverage cold chain monitoring technologies to ensure the items are always kept in the required temperatures and humidity levels.
3. Improve your regulatory compliance
One of the best ways to establish a seamless cold chain monitoring process is to comply with regulatory bodies. The U.S. federal agencies, European Union (EU), and other regulations in various countries, including the International Air Transport Association (IATA), have specific standards for temperature-controlled transportation of pharmaceutical products.
Using reliable IoT cold chain monitoring systems simplifies temperature tracking to ensure your pharma products’ compliance, safety, and quality maintenance.
You’ll also access all the necessary temperature and product location data for audits easily without manually extracting and consolidating the information.
Understand and apply the guidelines and regulations, such as the Good X Practices (GxP). This ensures that food products, vaccines, and medicines meet the highest quality standard, are efficient, safe, and meet their intended use.
The GxP consists of the five elements (5Ps) that provide guidelines to ensure that products, from manufacturing and processing to distribution, are safe to use. These are:
- People. This includes fully trained personnel who know the rules, including their roles and responsibilities well.
- Procedures. This refers to the documentation of investigation reports and the crucial processes.
- Products. This includes the raw materials specifications, finished products, components, testing, records, sampling, and manufacturing practices.
- Premises and equipment. This contains specifications of maintaining equipment to prevent cross-contamination.
- Processes. This includes the defined rules and regulations, control procedures, and documentation guidelines.
Improving your regulatory compliance can help enhance your pharma cold chain monitoring process.
4. Reduce cold chain equipment downtime
Wireless sensors that track the vibration and temperature of cold chain equipment can help reduce unplanned equipment downtimes. This can facilitate efficient predictive maintenance and prevent issues and events that lead to pharma product waste.
IIoT-based predictive maintenance utilizes real-time information and analytics to predict when cold chain equipment will require replacement or servicing. Implement predictive maintenance programs to make your maintenance planning more efficient and effective.
Use IIoT analytics and wireless sensors to track your cold chain equipment and get real-time insights into the equipment’s function and your products’ condition. This helps ensure your assets remain in optimal condition and delays the need to invest in new equipment frequently.
Reducing cold chain equipment downtime through the right technology can also help you eliminate product waste, spot cold chain issues, and keep your product safe in transit and storage.
Streamline your cold chain monitoring process
Leverage the best pharma cold chain monitoring technologies, maintain compliance with regulations and follow best practices.
Doing so helps ensure you maintain your pharma products’ quality and integrity throughout the cold chain stages and process.
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