Cold chains should never be broken. Carefully monitored and temperature-controlled, cold chains are supply chains that distribute heat-sensitive products such as medicine and dairy. Cold chains hang in a delicate balance, a complex distribution process that must constantly analyze, measure, control, document and validate products, with absolutely no room for error. Dire consequences, such as inactive vaccines or contaminated food, not only seriously harm consumers, but result in lost revenue, excessive waste and distrust in brands, with high associated costs in cases of recalls or legal pursuits.
Good Distribution Practice guidelines for the proper distribution of medicinal products for human use have been around for a long time. GDP guidelines are designed specifically to regulate the distribution of medicinal products from the manufacturer to end user (the patient).
There are more than 35 GDPs globally. For example, standards set by regulatory bodies such as the World Health Organisation require temperature-sensitive cargo such as pharmaceuticals and perishable goods to be kept between 2 to 8 degrees Celsius at all times, from manufacturing all the way to end consumers.
The supply of vaccines to many developing countries is undermined by poor or inadequate cold chain infrastructure. These typically hot climates, combined with limited or outdated transport networks, place pressure on the chain. There have been cases where exposure to heat has led to inactivated vaccines being given to patients, with families believing they have been immunized when in fact they are put at greater risk due to spoiled ingredients. In order to rid these countries of simple diseases and help mitigate the spread of life-threatening illnesses, we need to transform the cold chain all together.
Fighting the Heat With Blockchain
Blockchain technology is the digitization of supply chain records, with all participants, from raw material suppliers and manufacturers to retailers, contributing their track and trace data to a shared ledger. Any participant can access the ledger, but can never change the logged data.
Every single food or pharmaceutical item can be assigned a cryptographically unique identifier at the start of the cold chain. This unique, strongly encrypted code can then be entered into the shared data ledger, and the history of all products can be accessed on the blockchain archive. These unique identifiers can be represented by barcodes, near-field communication (NFC) or radio frequency identification (RFID) tags in the physical logistics world. Instead of a fragmented supply chain with data locked up in silos, we end up with a library of timestamped transactions encompassing full logistics process.
This end-to-end transparency and traceability will streamline the entire process. Any issues with temperature resulting in unsafe food or medication can be detected swiftly, and resolved within a matter of hours. Response times can be minimized, and overall food and medicine safety improved.
The Power of IoT
Applying blockchain means that we can closely and carefully monitor our cold chains, securely documenting the storage temperatures along every point of every product’s journey. In the United States, the Sanitary Food Transport Act now requires the collection of many data points across the supply chain. Integrating blockchain technology with internet of things (IoT) devices is the best way to do this.
There are many examples of IoT devices that can be used for cold chain food and medicine safety measures, including handheld mobiles that scan pallets and capture information, temperature and humidity sensors that document real-time data, and even advanced packaging technology which can automatically log abnormalities on the blockchain archive for any participant along the chain to check and be alerted to. IoT devices can track the exact rise and fall of temperature over time for each item, so participants are aware of which products have been exposed to dangerous heat.
The use of IoT also reduces the cost of complying with GDP rules. Even if drugs are not subject to temperature, there is still a GDP obligation to report any deviation such as temperature to the distributor, as well as the recipient of the affected medicinal products. In those cases, IoT devices can replace expensive refrigerated containers, fixed assets and rolling stock.
IoT devices powered by a unified network can also help sustain controlled temperature environments across the entire production process. Advanced preservation infrastructure can be integrated with both blockchain and IoT to ensure that all goods travel through a continuous, unbroken cold line.
Blockchain technology also built-in redundancy, as transactions on the blockchain can be verified, processed and logged independently by multiple nodes across the chain. This means no individual node is crucial to the database system as a whole – without a central administrator, any blockchain node which goes down can always catch up on transactions that it missed.
Tracking and Preventing Unsafe Products
Additionally, when food or medicine is made unsafe by inadequate temperature control, poor recordkeeping and traceability methods mean that companies can sometimes take weeks to find the source of the problem. Unable to recall only liable products or batches, all items along the supply chain are affected.
Standards set by Food Standards Australia/New Zealand (FSANZ) require that all businesses involved in the wholesale supply and importation of food must have sufficient recall methods in place. Businesses must maintain up-to-date records of where every batch of their product has been supplied, including any unique identifiers and the details of volumes dispatched.
Paper-based records are an unsecure way to log data, failing to provide a holistic understanding of where and how problems along the supply chain occur. For this reason, end-to-end transparency and traceability is critical to ensuring that response times to unsafe food or medicine is minimized, and that overall safety measures are improved. This can be done using blockchain technology, as businesses can track in a matter of seconds where unsafe products are now located, and where along the chain the temperature was originally compromised. However, many country-specific FDA and CDC regulations still stipulate that paper is the prevailing legal source for temperature control. The legal prevalence of paper over digitized records creates a delay in the adoption of next-gen technologies such as blockchain.
Blockchain will innovate our cold chains, making them as resistant to heat and risk as possible. All we need now is to drive the development and integration of this transformative technology, so we can safeguard products, brands and, most importantly, our consumers.
Pieter Vandevelde is chief operating officer of TBSx3.