Temperature Controlled Logistics: Optimising Strategies and Cost-Balancing

In the mission to further refine a pharmaceutical’s path to market: Risk conduct, compliance and cost balancing are three key pillars to be optimised in any temperature controlled logistics strategy.

When increasing the understanding of a certain route and the ability to navigate its risks, the application of both continuous monitoring and lane validation is a key tactic for robust lane qualification. 

Risk assessments also need to establish transparency onthe network of professionals who support the product through the cold chain. Jim Bacon, Cold Chain IQ columnist, illustrated an exercise which embodied thisthat was implemented in his time at Grifols. The Mock Shipment Call was a method used to eliminate risk and qualify the lane by having every single stakeholder on that lane present to clarify and run through their role in the chain. He commented: “All too often, an excursion can be attributed to some form of human error and more often than not this occurs during a transfer or hand-off from one service provider to another. I have addressed this issue in many presentations over the past many years, referring to it as “the weakest link.” 

Shippers that improve these handoffs through robust and disciplined process steps and improved agreements with providers have mitigated their risk by securing “stock throughput coverage” insurance which provides continuity coverage for shipments. This however does not eliminate the risk, so extra steps and a continuous loop of review is required.

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“More recently, due to increased regulatory scrutiny, shippers have engaged in lane qualification, serving to document the process, test and approve with live data. Through collaboration with our cold chain partners, we have taken it a step further and engaged in a process we call “The Mock Shipment Call”. This is a teleconference call we engage in before agreeing to execute a live shipment for a new shipping lane.”

Another area highlighted by industry commentators that needs increased use within the cold chain – is stability budgets to calculate the permissible Time Out Of Storage within the manufacture and distribution of the pharmaceutical. TOS will impact the product’s shelf life, so this time used needs to be measured and balanced. Hazards within transportation represent larger threats to the cold chain with the prospects of physical contact, handovers and unforeseen delays, so the TOS can be useful in managing temperature excursions.

Dr Rafik Bishara, Ph.D, Technical Advisor, Retired Director, Quality Knowledge Management and Technical Support, Eli Lilly and Company noted that to shirk the use of a stability budget could be perceived as an indicator that professional is not following modern industry best practices. Regulators are likely to enquire about stability and the protocol deployed to generate the data and the implementation of a stability budget. Rafik stresses that to avoid implementing a stability budget is in fact taking on a risk – dependent on the inspector they are allocated and whether that inspector decides to focus on the stability budget. 

Industry figures have called for increased market consensus on the risk assessments a lane qualification should contain. Dr. Bishara has stressed the need for an industry task team for lane qualification – with the benefit being that standardscan be utlined to specify required handling, storage and distribution to to the patient. However, many have noted that these standards would need to be flexible to allow approaches to be tailored to specific scenarios.

Standalone cases would require the end user to invest in analysis to assess the most effective method for transit and temperature profile. Looking at streamlining financially through the cold chain, one hotspot to assess is packaging and the consolidation of volumes. Both active and hybrid shipping systems quite often demand less distribution flexibility due to their reusability which requires a closed distribution loop. One cost reduction tactic to apply in planning phases is to evaluate the payload volumetric efficiency – leveraging innovative techniques and metric calculations to maximise container utilisation. This  involves the identification of where moves can be consolidated and packaging can be downsized. This will reduce the cost per unit based on packaging spend and also in freight savings as less space is occupied. 1

Deploying a selection matrix can compare and analyse attributes which are critical to your firm’s projects to verify decision making – which is integral especially for leased solutions.  

Cold Chain IQ spoke to a selection of temperature controlled logistics experts to gain insight on the latest strategies and cost balancing techniques in the industry.