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The cold chain

The three inviolate links in the cold chain

Maintaining a favourable temperature can be a challenge

Anyone that works within the pharmaceutical industry knows how important it is to keep substances within a desired temperature range. There have been myriad instances over the years where vaccines have been shipped to warm nations with no regard given to temperature, resulting in the vaccine itself becoming inactive and placing patients at greater risk.

Maintaining a favourable temperature for pharmaceutical or food products can be a challenge, but developments in technology have made it possible to get them where they are needed while maintaining a stable temperature, normally between 2ºC and 8ºC. The difficulties facing a firm that wishes to maintain a clear cold chain are numerous, and many firms are releasing a variety of solutions to aid companies that require cold chain logistics, tracking, and verification.

The truth is, the technologies involved in cold chain maintenance have improved over the last few decades thanks to microprocessors and other computer-related innovations, but the biggest changes have come with regard to how products are traced along the links in the chain and how each point along the way has become clearly accountable. Thanks to international standards and best practices combined with Internet access, companies can now pull up a page to perform a number of tasks that would have been unheard of just a couple of decades ago. Now, they can take a look at the shipping history of a particular item, see where it is along its route at any point, note what batches are shipping in concert, check that appropriate personnel have signed off on receiving and passing products on, even check the temperature of products that have been provided with environments monitored by sensors. All this is at the forefront of making sure modern cold chains are completely traceable and monitored, from the second the product leaves the filling line to the moment it's used.

So really, maintaining a cold chain isn't simply limited to better tech or data, it has to be a combination of being able to stay on top of three things simultaneously: people, equipment, and information.

Select any of the following icons to learn which factors may be controlled and which can not.

Manageable factors

Packaging
Route
Carrier
Timing

Uncontrollable factors

Weather
Handling
Placement
Politics & Social issues

The People

One of the most difficult things to manage in a cold chain is the variety of people that will handle the product between the facility where the product is produced/packaged and the point of use. A company might ensure that its staff are highly trained to be able to deal with issues as they arise, but once the product has left the hands of knowledgeable personnel, a lot of faith is required while the shipment makes its way to its destination. Companies, therefore, are making product shipments as foolproof as possible, taking human decision making and intervention as much out of the equation as they can be. Where humans are fundamentally necessary are as a part of the custody chain, particularly when products cross international boundaries, so that a clear path of temporary, professional ownership is established and can be cited as required. Documentation is critical, with humans using technology to gather data to correct errors and improve processes. Though serialized labels, scanning, and visually aware robots can go far in making transport logistics run as smoothly as silk, humans are still an intrinsic part of the cycle for the moment, including our fallibilities and quirks.

The Machines

The primary machines used in pharmaceutical packaging to enhance cold chain maintenance, apart from packing and bundling, are those associated with making sure each single item produced has been given a unique serial identifier. So, machines that print serial numbers and get them on boxes are the key focus. Printing clear identifiers on boxes, getting codes in the right place for people to see and recognize, and feeding data back into a central information repository for later analysis and auditing are all tasks that require meticulous precision and logistic know-how. Incorporating robotics is proving to be a boon, especially now that the processing power behind robots allows many to see. 

There are robots that can detect differences in product colour and shape and sort them appropriately; there are also robots that can take products on a line, scan them, and bundle them for shipment, sorting consignments for placement on pallets and ensuring they are prepared for correct delivery. As a part of the cold chain, robots can serve in many capacities, especially when used to direct traffic effectively. There's only so far they can go, however. For the moment, robots are support items, speeding up repetitive tasks. Soon, they'll become a larger part of serialization and the cold chain, especially when stringent new regulations surface over the next few years. Firms that opt for traditional, low-tech approaches swiftly run the risk of becoming antiquated and non-competitive.

The information

In this age, data flow must be the focus of any firm that wants to retain its customers, keep end-users satisfied, and keep market share. Hiring the right people and using the right machines are central to proper operations, but having excellent information in order to make informed decisions is the umbrella under which all resolutions occur. Knowing (not suspecting) that the cold chain was maintained throughout a pharmaceutical's transit from production to use ensures it will work as intended upon arrival. Knowing who handled the product at every moment establishes a responsibility chain that is important in rooting out inefficiency, incomprehension, and even graft. Good information allows a company to look at the day to day minutiae of a system and make corrections. With online access, many of these issues can be detected in real time and addressed immediately. Keeping the cold chain completely inviolate will never be achieved by hiring the best people or inventing/buying the best possible machinery, it will be achieved through the correct management of minute details and swiftly acting upon the slightest of deviations within an acceptable range.

Select the stages to learn about what they entail.

1 Production

Production

The pharmaceutical is produced within strict guidelines and immediately enters the cold chain, normally prior to being completed.

2 Refrigerated processing & packaging

Refrigerated processing & packaging

Each product is put into a container appropriate to its use, then into secondary packaging for shipment, serialized to ensure traceability and accountability.

3 Refrigerated prep storage

Refrigerated prep storage

Prior to being shipped out from the manufacturing facility, products must await delivery, whether for hours, days , or weeks. This time is also part of the cold chain and must meet current standards.

4 Refrigerated transport to hub

Refrigerated transport to hub

Normally, this is ground transport as central hubs are built within the range of refrigerated trucks.

8 Delivery to POS or usage facility

Delivery to POS or usage facility

From smaller centres, pharmaceuticals are taken directly to places where they'll be used, such as hospitals, local clinics, or aid centres in developing nations.

7 Storage at small distribution centres

Storage at small distribution centres

Local areas have their own refrigerated and safe places for storing pharmaceutical products, to be taken about by ground transport.

6 Refrigerated distribution

Refrigerated distribution

Here, any number of transport methods can be used, by land, sea, or air. Transport methods take products from hubs to smaller centres worldwide.

5 Storage in large central hubs

Storage in large central hubs

Large central hubs act as clearing houses for refrigerated products. The appropriate warehouses act as cold room storage facilities for a number of brands, awaiting shipment to local centres.