Why It’s Dangerous To Dive In At The Deep-End Of The Data Lake

Sustainable logging

CSafe Global's Jonathan Neeld discusses the direction that remote, real-time, and continuous temperature monitoring technology is taking, the pros and cons of cold chain systems with inbuilt data capture sensors, and the risks of 'backing the wrong horse' from a technological perspective.

The pharma and bio-tech industries are continuously seeking reliable ways of ascertaining the location, payload condition and the ambient environment surrounding temperature-sensitive products during transit. It's rapidly becoming a regulatory, safety and commercial necessity.

We are surrounded by data collection , data storage and data relaying technologies from Bluetooth, Wi-Fi, RFID, GPRS, satellite, cloud, data sticks, smartphones, among others. A bewildering array of different monitoring and capturing technologies makes for a big headache when it comes to selecting the best hardware device for a particular need. And, when you factor in the pace of technology change in this field and the fact that there are no 'one size fits all' solutions, the adoption of a specific monitoring technology may not be an approach that makes sense. With this in mind, there are a number of basic considerations that should be taken into account when considering data collection and transmission systems and services.

1, 2, 3.. .

Firstly, shippers, forwarders and airlines need to be looking at systems that are, as far as possible, ‘future-proof’. Data monitoring and transmission technologies are advancing rapidly and as we edge closer and closer to the prospect of real-time in-flight monitoring, users need to be sure they are not committing themselves to a technology that will be obsolete in a short period of time.

Secondly, decision makers must consider flexibility. While they may be bound by common regulatory parameters, every shipper has their own ideas about the best way of monitoring its particular products for quality. And rightly so, because all products are different, sometimes very subtly different. This need for flexibility and choice is further accentuated by the sheer number of different shipping environments, distribution conditions and mode choices that are available.

Thirdly, we are faced with the problem of conflicting regulatory requirements in Europe, the USA and other air-regulatory jurisdictions. As far as the use of short-range devices are concerned, individual carriers must review the manufacturer’s data and submit it to the FAA as part of their operational procedures as well as put in place the necessary training and infrastructure to ensure correct usage. In Europe on the other hand, the airlines have more responsibility for all types of devices and it is the responsibility of a carrier's engineering and quality groups to assess, select and implement any T-PED (transmitting portable electronic devices) systems that are adopted or approved. Since we are unlikely to see a harmonisation of the different national and regional approaches any time soon, it is important to understand that using an unapproved device can have serious consequences.

Download the early draft agenda for the Temperature Controlled Logistics Leaders Forum DACH taking place from 25-27 October, 2016 in Zurich, Switzerland. Download the agenda here

Compatibility issues

There can be issues surrounding the compatibility between different monitoring and tracking systems. If all cold-chain packaging manufacturers started embedding their own monitoring hardware and software into shipping containers, then shippers, forwarders and airlines would quickly find themselves having to deal with numerous different data sources, data formats, data devices and data locations. It is far better for individual shippers to define their own monitoring and tracking needs and then apply the resulting solution(s) to their supply partners.

Shippers also need to be considering the impact that mandatory track and trace security systems are going to have on the whole product monitoring process. For example, how sensible will it be in future to be running track and trace and environmental monitoring systems in parallel? Increased costs are just one of the obvious considerations and cross analysis and validation will be complex and time consuming.

In practice shippers often need very different things. Some shippers need device-independent data recording, some have particular data back-up and data security needs, some need to use bespoke hardware or software and others just need ongoing flexibility. The need for flexibility in data capture can be readily appreciated by taking into account the 'human factor.' A large proportion of temperature excursions and other unnecessary impacts during transportation are caused by simple human error. For this reason it makes sense for a shipper to use a single data gathering and transmission solution for all their shipment methods; one that is deemed fool proof and does not rely on complex receiving-end infrastructure, meticulous training or additional cost.

Vendor-fitted/integral container monitoring solutions

There are real downsides to a reliance on vendor-fitted tracking and monitoring solutions. Ready-fitted monitoring equipment not only presents the buyer with ‘a no choice solution’ but also creates the not-insignificant burden of ensuring that all distribution partners in the supply chain carry the necessary approvals for its use. By example, unauthorised use of a device not approved for flight could result in a hefty fine for the airline.

There are a number of existing opportunities to procure off-the-shelf packaging solutions that are pre-fitted with compatible monitoring equipment. However, as well as restricting choice, these 'built-in' solutions can add significantly to the cost. It must be borne in mind that the cost of electronic apparatus has fallen dramatically and the cheapest product monitoring solutions today are not necessarily going to be the cheapest solutions tomorrow.

This rapidly reducing cost of monitoring is a good reason why it makes sense to be careful about getting locked in to a proprietary system too early. For example, there is currently significant development in low-cost 'Bluetooth Smart' devices that piggyback off smart phones or Wi-Fi networks. These devices will be capable of utilizing communication and location functions for real time data streaming to the cloud. This will avoid the data costs associated with many devices utilizing cellular or satellite systems.

The future

The future for in-flight pharma monitoring/tracking is likely to be hybrid systems which use a combination of technologies to provide real-time connectivity, global geographical coverage, additional monitoring features, dynamic control of container environments, a high degree of reliability and all with minimal power draw. Technologically, what we see now is just the tip of a big iceberg, with hybrid systems using Bluetooth and Wi-Fi looking to be the next phase.

The emphasis will continue to shift from monitoring to control with the cost of the equipment, rather than the associated support systems, likely to continue to fall. There will also be further global harmonization of technical standards and regulation but this will be much slower than technical developments. The biggest challenge of all will be whether organizations, regulators and other stakeholders will be able to cope with the sheer volume and complexity of data generated and be astute enough to take advantage of the insights it brings.

All of these are reasons why it is sensible not to be jumping in at the deep-end during this period of rapid change by implementing a data tracking/monitoring technology which could have a 'limited life expectancy'. Cargo safety and security will remain the paramount concern for airlines and aviation regulators and the almost certain consequence of this is that we will see no let-up in technical and air worthiness scrutiny. At the end of the day, when we are talking about the safety of drugs for human consumption, it is vital that the quality controls put in place during physical transportation are driven by need and necessity rather than being subject to the limitations imposed by a manufacturer's stock solution.