Cold Chain Study
The Cold Chain Demonstrator was developed to showcase the following:
- For Air, Road and Sea corridors; real-time and/or periodic live updates of event records to ascertain product viability (e.g. core and ambient temperature, location, tamper, custody).
- Identify necessary interfaces with other systems (e.g. Customs messages) and enhanced reporting demonstrating ‘in-control’
- Showcase potential for active management of temperature sensitive products in harsh environmental conditions. This problem is further accentuated if extreme weather events or long term environmental changes are experienced.
- Utilisation of standards-based data and message formats (non-proprietary) to facilitate commercial and regulatory interoperability among many involved parties.
- Evaluate systems suitable for a range of cargo configurations: heavy loads and non-standard packing and irregular shipping configurations within the air cargo multi-modal environment.
While electronic Cold Chain innovations offer the promise of safer, more secure, transparent and economical life sciences supply chains, their very transparency has implications for process knowledge, cost, and the required organisational structures. Advanced sensors and wireless monitoring enable us to capture multiple parameters such as temperature, humidity, dew point and location. In parallel, improved data management tools offer a more transparent and strategic analysis of collected data. The resulting enhanced visibility invites us to rediscover how to effectively manage the actors and the work of temperature controlled international logistics.
No package can be maintained at a fixed temperature indefinitely without elaborate environmental controls in place . Temperature control is the major issue that the packout and shipping process addresses. Bulk drug shipments are sent by fastest feasible air/road routes to and from Europe, the US, Asia and ROW to ensure the time spent enroute is minimised. The challenge from a shipping or logistics point of view is how to optimise the multiple variables impacting the shipment’s temperature: shipping duration, environment, route, storage and handling. Package temperature is a function of its initial temperature, the ambient environment, capacity of coolant , and insulation.
Real-time telemetry services for international logistics are notable in 2010 more for their absence than for application; cold chain visibility remains an open issue. However, rapid advances in telemetry technologies are drivers for innovative asset-tracking devices and services.
Cold chain and chain of custody is an area of growing concern for the life sciences sector generally. An AS-IS analysis was conducted to get a better understanding of the practical reality of servicing the cold chain shipping process to determine the following:
- Who is involved in servicing, managing and controlling the shipment?
- How are SOPs (Standard Operating Procedures) and other processes used to structure and manage the shipment?
- What technologies and data standards are used or are available in the actual working environment?
- Where are the key control points and chain of custody events, located?
- What are the contexts, incentives and needs of involved parties?
The actors involved in cold chain shipment are grouped accordingly: traders (including manufacturers and suppliers such as carriers, airlines, drivers, customs brokers or clearing agents), regulatory (national agencies such as customs or medicines control), and market groupings (representative bodies with remits overlapping logistics, exports, and user groups). All of these organisations make up the cold chain community; they are all involved or interested in day-to-day shipments, their delivery, control and regulation. Furthermore, they are all impacted by innovation developments in international cold chain practice.
To understand the process and community we observed and recorded procedures for readying containered drug shipments for air handling and movement; arrival, warehouse, and transfer handing processes airside. Shipments were followed from end-to-end, from initial retrieval and pack-out at the manufacturing plant, to truck, to plane, Customs clearance, arrival, Customs entry, road transport and receipt at the end factory.
Most importantly, manufacturers wanted “to know what was happening as it happened” in order to proactively take corrective action and to minimise risk or avoid loss.
We determined that greater visibility could be provided, based on innovative reconfigurations of technology, services and inter-organisational interaction. Specifically, this could involve an open approach to developing and piloting new devices, information services, and work systems. To test these possibilities, an innovative technology pilot could be designed to operate in actual multi-organisational contexts across multi-modal supply chains over road, sea and air.
Customs or Medicine agencies increasingly ask industry to ‘show us your data, show us you are in control.’ 3PL and air carriers need to get to grips with how active tracking affects them. The most innovative carriers are already involved in this work. Whose problems does active asset tracking solve? If customers demand it how can the need be met? Does 3PL view tracking as a threat, or benefit? Will third party services operate independently of 3PL or should they integrate. Should such services be licensed under their own brand or developed in-house and offered as part of the 3PL bundle of services? What is the role of standards? We see similar innovations taking place in mobile telephony on aircraft with services from operators like OnAir being rolled out. Extending this idea to air cargo is not such a large jump, it hints that air carriers may well be the key decision makers.
For more detail see the Cold Chain Demonstrator