Wireless Sensors and Pharma Transport Best Practices
Wireless sensors have become an essential part of pharmaceutical transport even before the covid outbreak. The world now lies in the successful and organized transportation of drugs and vaccines worldwide. It is necessary for the logistics provider to be able to accommodate the highly specialized needs of the market. There are several challenges that raised the need for these wireless sensors in the pharmaceutical shipment process that would require special attention.
Some of the pharmaceutical shipping challenges include:
- Possible patient health risks due to improper pharmaceutical transport
- Diverse pharmaceutical properties
- Laws and regulations encompassing pharmaceuticals
- Strict temperature regulation requirements
- Shipping and insurance costs
With all these factors combined, the pharmaceutical industry is reportedly a $13.4 billion industry. Temperature deviation has severe repercussions for medical products. Improper temperature regulation can lead to significant financial losses and end-user claims. In order to maintain the temperature in transportation fleets, several steps need to be taken into consideration.
Temperatures and Vehicles
Different pharmaceutical products have various temperature requirements. Liquid nitrogen needs to be kept at -190ºC. Frozen products should be kept at -20ºC. Meanwhile, drugs and vaccines usually need to be kept between 2ºC and 8ºC. However, some products also require room temperature around 20ºC.
Pharmaceutical transport vehicles can be isothermal, chilled, or refrigerated. In transporting pharmaceutical products between the manufacturer’s facilities and the distribution warehouse, large refrigerated trucks are used. Meanwhile, for local distribution center deliveries, Isothermal vans or small refrigerated trucks are used.
Vehicles used for pharmaceutical transport should adhere to best practices in terms of temperature, cleaning, and insulation parameters. This is essential to maintain the integrity of the products. These measures are outlined in the Good Distribution Practice guidelines.
Pharmaceutical transport operators need to adhere to stringent permanent temperature control. They also need to meet the storage and handling conditions as established by the manufacturer for every product. All vehicles should also be equipped with the necessary systems and devices to allow temperature control throughout the transport. It is also essential that the vehicles comply with the required safety and hygienic conditions. Products should also be adequately stowed in the vehicle, so they do not deteriorate during the transport.
Prior to beginning the trip, transport operators must first properly inspect the vehicle. The transport refrigeration units and the trailer itself should be carefully checked. This will minimize the occurrence of a possible malfunction during the transport.
Different loads might have various temperature requirements. A multi-compartment solution may require the various areas of the trailer to have different settings. A visual inspection will prevent issues from arising. If left undetected, this can lead to load damage while they are being transported.
Vehicle inspections may come with a lot of paperwork. Improper documentation may lead to shipment delays. Therefore, it is essential that the required documents are filed appropriately to ensure seamless operations. Telematics companies may also offer all-in-one online paperless solutions. These notify office-based staff in case an issue arises, which allows them to take a proactive approach in the situation. Utilizing these online processes reduces weeks of administrative tasks. It also increases the safety of both the drivers and the public.
In shipping and logistics, it is important to know the specific requirements of the cargo that is being handled. In pharmaceuticals, compliance with regulations is essential. A thorough understanding of best practices is necessary in adherence to pharmaceutical FDA regulations, DEA regulations for controlled substances, DOT hazardous material laws for transporting live organisms or chemicals, and the specific best practices for each pharmaceutical product as specified by the manufacturer.
Hiring a compliance lawyer is vital in pharmaceutical shipping. The company may be at risk for substantial liability if the regulations are not met as specified by the guidelines. A legal counsel will be an excellent investment to dissect the various regulations involved when shipping pharmaceuticals.
Pre-cooling the cargo is a vital step in shipping pharmaceuticals. The purpose of pre-cooling the cargo at the required temperature during the container’s connection to the storage unit is to ensure that the cargo’s integrity is maintained during transport. Before the operator loads the pallets, the required set temperature should be reached first. Live monitoring should be implemented while it is being transported. This could be done by setting up the applicable thresholds and trigger alerts.
For multi-compartment temperature solutions, the temperature should be brought down at a lower level. Through this, the company will be able to have substantial savings in fuel expenditures.
Proper loading practices
When transporting perishable products, correct airflow and circulation must be taken into account. This is particularly true for pharmaceutical products. If there is no proper airflow and circulations, hot spots may arise. If undetected, these can compromise the integrity of the entire cargo supply.
Controlling Temperature Throughout Shipping
Several refrigerants can be used to ensure proper temperature regulation throughout the entire shipping process. Working with a logistics provider that specializes in temperature control would be an ideal solution to mitigate possible concerns from arising.
Some refrigerants used in temperature-controlled logistics are:
- Dry Ice
Dry ice is a strong chemical refrigerant. It is often used in cold chain logistics. However, it might be difficult to manage properly. For products that need to be stored in below-freezing temperatures, the use of dry ice is a viable solution. When using dry ice, it is important to take into consideration the CFR regulations.
- Refrigerant Gel Packs
For products that need to be kept at a refrigerated temperature of 32 to 60 degrees Fahrenheit, refrigerant gel packs are often used. These refrigerant gel packs provide temperature-controlled packaging that allows proper temperature regulation.
- Insulated Styrofoam Coolers
Insulated Styrofoam Coolers have the ability to suppress heat transfer. As a result, they are great to be used alongside other cooling methods such as gel packs.
Pharmaceutical Product Packaging
In order to meet the specialized requirements of pharmaceutical products, specific packaging solutions and shipping materials need to be used. Several techniques can be used to aid the shipping process, like the use of specialized corrugated shipping boxes, biodegradable air pillows, absorbents to manage excess moisture, and hazmat placards and shipping labels in compliance with UN standards.
The use of wireless sensors allows data of the environmental temperatures to be recorded. This also allows for the recorded data to be remotely accessed by the cold chain staff. Since it sends real-time alerts in the event of temperature excursions, the use of wireless monitoring solutions intercepts possible critical deviations from occurring.
The wireless sensors should also be able to provide temperature recordings of the journey in both digital and physical formats. This will serve as an added safety precaution and a way to avoid expensive claims.
Humidity sensors should be used for products sensitive to changing environmental conditions. The probes installed should also be calibrated every six months if possible.
One provider that has a comprehensive temperature monitoring system is AKCP. AKCP’s temperature monitoring system can be used to effectively monitor environmental conditions. It features wired and wireless sensors, battery-powered data loggers, and alarms. The use of AKCP’s Wireless Temperature Monitoring Solutions ensures compliance with local regulatory requirements for the storage and transport of temperature-sensitive pharmaceutical products.
Temperature monitoring solutions and telematics can be installed separately or as an integrated solution.
An integrated solution would allow for monitoring of the fleets in real-time. The moment the temperature falls outside the required conditions, managers are instantly notified. This allows staff to resolve the issue before it becomes a serious problem that can destroy an entire load.
Using telematics would also allow for route planning, job management, GPS tracking, camera systems, ePOD integration, and customized vehicle checks. It is important for the shipping partner that will handle the medical cargo to have previous experience in pharmaceutical transport.
There are several cold chain logistics carriers that have specialized experience in the field. International shipments should have installed temperature control solutions at every step of the process. Shipment carriers with pharmaceutical experience will be able to aid with the necessary packaging requirements and regulatory compliance.
A carrier with pharmaceutical experience would also be able to provide agile visibility options. This will allow better tracking of the shipment throughout every step of the process. There is also an option to remotely check the temperature of the shipments through installed thermometers in their vehicles and warehouses.
AKCP Wireless Sensors and Monitoring
Place the NIST calibrated, certified temperature sensor with internal calibration check and failover on your shipment, or medical refrigerator. Monitor temperature and log data internally. Anytime the sensor is within range of an AKCP Wireless Tunnel™ Gateway (WTG) data is synchronized and uploads the data to AKCPro Pharma-Mon Server. Install WTG’s at strategic points through your vaccine cold chain. Connect via WiFi, Ethernet, or cellular data. For live monitoring during transport, such as inside refrigerated trucks, a GPS option is available. Through this visibility of the whole supply chain, you can minimize temperature excursions and ineffective vaccines.
The pharmaceutical cold chain is a highly complex process that involves several stages. Each stage needs to have seamless operations to ensure safety that the pharmaceuticals delivered are safe for human consumption. In order to safely transport the drugs and vaccines, partnering with experienced logistics partners, using wireless sensors soloutions, and complying with various regulations are important. With proper monitoring, compliance and use of relevant equipment, financial, legal, and possible health repercussions will be averted.