Biocair - Handled with care

Pharmaceutical products require special conditions during transportation. Medicinal logistical specialist Biocair provides controlled room temperature courier services to ensure that every product arrives in perfect condition.

Any pharmaceutical products need to be kept in an environment within a particular temperature band; familiar examples are frozen and cool chain (2-8°C) products. Both temperature requirements are based on keeping products cold or frozen while the external environment is hotter. Other pharmaceutical products need to be kept within a warmer environment than the typical ambient temperatures of transport routes.

Some medicines and healthcare products are distributed and shipped to patients without temperature control; for example, transdermal patches, and over-the-counter tablets and medicines. While many of these products are very stable, some risk quality degradation if they are subjected to temperature extremes. Extremely cold temperatures may freeze products, while cool temperatures can still affect liquid suspensions. Similarly, heat from high-temperature surroundings can degrade medicines and affect chemistry through, for example, crystallisation in medicinal patches.

While many of these products are shipped without temperature control, where there is a risk of degradation in extreme temperature environments they are often distributed in shipping systems that maintain a warm, not hot, temperature environment. This is known as controlled room temperature (CRT). Often, the temperature range specification of these shipments is 15-25°C. Sometimes, these temperature thresholds are wider, say, 2-25°C, where a cooler temperature is acceptable or 15-30°C, where a hotter temperature is fine. Wider temperature bands are beneficial as this gives greater flexibility for the temperature-controlled logistics solution. Given increasing regulatory requirements, more pharmaceutical products and research samples are being sent using CRT shipping technology.

"Given increasing regulatory requirements, more pharmaceutical products and research samples are being sent using CRT shipping technology."

A pharma industry manufacturer may make the decision that one of its product lines needs to move from ambient shipping to a CRT. Similarly, this could be imposed by a healthcare regulator if there had been problems associated with temperature damage.

Shipping implications

It's worth being aware of the consequences of this on the likely shipping solution. The product line may be contained within individual patient packs and multiple packs contained within grouping cartons. With no temperature control, these cartons can be stacked directly onto pallets for distribution. The ratio of the volume on the pallet taken up by product compared with the total volume available is an important measure in shipping. Excellent efficiency can be achieved if the grouping cartons are designed to give a good fit to the dimensions of the shipping pallet.

After moving to a CRT shipping solution, the configuration of a pallet begins with the components of the temperature-controlled shipping system. Usually, this means starting with an insulated outer container, which enables the internal environment to be shielded from outside temperature risks and slows down the rate at which these can affect it.

Within this container space, eutectic plates of phase change material (PCM) are located as determined by the validated shipping system design. This PCM is used to maintain the correct temperature range. The space remaining inside the eutectic plates layout can then be filled with product grouping cartons. It is not unusual for the product volume available in the design to be less than 50% of the outer volume of the complete pallet (Figure 1). On the left, a pallet is shown loaded directly with product cartons. On the right, is a similar CRT pallet system. Inside the insulated walls and PCM plates (in purple), fewer product cartons can be fitted.

Specialist logistics provider

Biocair knows that requirements for CRT packaging and logistics vary over the year. These increase during winter because colder temperatures give more concern about cold-temperature risks. Similarly, some hot emerging market destinations justify a CRT logistics solution during summer, especially if there are potential delays in an uncontrolled customs warehouse.

Specialist logistics solutions for CRT shipping are available. For some products and research samples, a CRT option must always be selected as a specific temperature band such as 15-25°C is required. With many other products and samples, the risk of degradation is limited and an assessment can be made as to what level of logistics solution is required. By using support from specialist logistics providers, smart decisions based on a risk assessment of the route can be used to ensure the solutions chosen are appropriate and efficient.

Logical logistics

Compromise isn't always a bad thing when it comes to logistics. Biocair explains how hybrid courier services offer a happy middle ground between the care and compliance demands of scientists and the frugal mindset of purchasing teams.

There is no mistaking that the pharmaceutical industry has faced turbulent times over the past few years and this shows no signs of stopping. Companies are making cutbacks everywhere . taking a good look at their expenditures and trying to shave costs wherever possible. Some easy targets are contracts for services that they use regularly, scrutinising the invoice for the little extras that have been happily paid each month: will anyone really notice the difference between a luxury and not-so-luxury bathroom soap?

For the pharmaceutical industry, logistics is a big part of daily life. But unfortunately, due to the nature of its shipments, it can't just be 'thrown in the post'. The majority of pharmaceutical shipments require licences and specialist attention and therefore need to be couriered by a specialist.

This raises the question, "Why ship with a specialist courier, rather than an integrator service?" The obvious answer would be to benefit from the specialist's knowledge and expertise . it can do things an integrator cannot. But this can come at a price and the value of this service is often difficult to demonstrate to the people paying for it.

It has always been a challenge for pharmaceutical companies to get the balance right between service and cost in terms of logistics. This is demonstrated by the internal struggle between the scientific community and purchasing teams. The scientist is looking for high levels of quality, compliance and capability, but the purchasing department is seeking a cost-effective service provision.

If we tip the balance too far towards the scientists' requirements, the specialist courier service they are looking for can be seen as too expensive. Too far towards the purchasers and the scientists aren't getting the peace of mind they need in terms of care and compliance.

How to get the balance right

The strengths and weaknesses of both service offerings need to be identified to ensure that the most appropriate solution is chosen for the specific logistical and compliance requirements. This is particularly important when dealing with a clinical trial.

The scientists are looking for reassurance that their hard work is being looked after throughout its journey. A specialist courier can provide processes that avoid risk and offer high levels of customer care. Their industry expertise allows them to offer services such as product classification, sophisticated packing technology and experienced staff holding relevant, industry-recognised degrees. But we need that integrator cost saving to get past the purchasing teams. We want the best of both worlds, so the obvious answer is to combine the two . a hybrid.

The hybrid service combines the pick and pack skills of the specialist courier with an integrator network and its worldwide footprint, allowing the customer to choose the level of care that is relevant for them: specialist pick up, combined with the cost-effective city-to-city service of an integrator. The key element of this service is demonstrating honesty, integrity and transparency. Providing this service means sharing the cost saving with the customer to the benefit of:

  • patients
  • scientists and investigators
  • purchasing teams
  • chosen logistics partners. Wisdom of the middle way

This type of service initiative would give an ideal compromise, rather than an 'either/or' scenario, to the benefit of the pharmaceutical industry. In a logical world, big pharmaceutical companies could reduce costs while maintaining a high level of regulatory compliance . and smaller research organisations could afford to employ the skills of a specialist, without spending their entire research budget on logistics.

  • Scenario one: a Big Pharma company has a large budget, so has a decent budget to spend on logistics, but is still struggling to justify the expense of a specialist courier with purchasing. It does not want to sacrifice services such as dry-ice replenishment, shipping paperwork, licences and compliance.
  • Scenario two: a small biotech firm has a limited budget and can't afford to send all of its precious shipments by specialist, but feels cautious about using an integrator. It can send most of the shipments with an integrator, but the occasional shipment would benefit from the 'icing on the cake' services that only a specialist can offer.

The answer to both is a hybrid courier service, using the skills and expertise of a specialist to pick and pack their items to industry standards.

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Figure 1: a diagram of a pallet loaded directly with product cartons (left) next to a CRT system (right) into which fewer product cartons can be fitted.
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