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European Pharmaceutical Contractor

Specialist Solutions

Temperature-sensitive pharmaceutical products must be appropriately and efficiently transported. Controlled Room Temperature Shipments can prevent temperature deviation and reduce the risk of product degradation.

Many pharmaceutical products need to be kept in an environment with a particular temperature band. Familiar examples are frozen goods and cool chain products (+2°C to +8°C). Both of these temperature requirements are based on keeping the product 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 in transport routes.

Some medicines and healthcare products are distributed and shipped to patients without temperature control – examples include transdermal patches, as well as many over-the-counter medicines and tablets. While many of these products are very stable, some do risk quality degradation if they are subjected to certain extremes of temperature. Extreme cold can result in frozen products, while milder cold temperatures can still affect liquid suspensions. Similarly, high temperatures can degrade medicines and affect chemistry, for example through crystallisation in medicinal patches.

Some of these products can be shipped without temperature control. However, where there is a risk of degradation in extreme temperature environments, they are often distributed using shipping systems or environments that maintain a warm, yet not hot, temperature. Such distribution is called controlled room temperature (CRT). Often the temperature range specification of these shipments is +15°C to +25°C, but can range from +2°C to +25°C where a cooler temperature is acceptable, up to +15°C to +30°C for a warmer temperature. Wider temperature bands are beneficial as this gives greater flexibility for the temperature-controlled logistics solution.

As an alternative to simply shipping with or without CRT temperature control, a decision can be made on each shipment depending on the likely external temperatures that will be experienced en route. Given increasing regulatory requirements, increasing volumes of pharmaceutical products and research samples are being sent using CRT shipping technology.

CRT Shipping Options

Once a decision has been made that a research sample or finished pharmaceutical product needs to be shipped under CRT conditions, the next step is to determine the method for shipping. A climate-controlled vehicle can be selected, thus providing an actively controlled environment for the shipped goods, along with a trained driver to monitor progress.

For many routes, this is not practical as the shipment’s route will require a fl ight as part of the journey. A vehicle can also quickly become uneconomic when distributing individual patient medicines over a wide geographical area. Self-contained, temperature-controlled packaging and containers would then become the best options.

Packaging Technology

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

It’s worth being aware of the implications of this on the likely shipping solution, particularly when geographical and distribution requirements are such that self-contained shipping systems have been chosen.

The product line will likely 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 to 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 – this enables the internal environment to be shielded from external temperature excursions and slows down the rate at which these can affect the product. 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 layout of eutectic plates 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 per cent of the outer volume of the complete pallet. Figure 1 demonstrates how this change might look. On the left a pallet is loaded directly with product cartons. On the right is a similar CRT pallet system. Inside the insulated walls and PCM plates (shown in purple), fewer product cartons can be fitted.

The simplest of packaging systems are based on the theory of thermal mass and components commonly used in cool chain shipping systems. Thermal mass is a concept which describes the inertia against temperature changes that objects may possess. Water-filled cool packs contain a significant amount of thermal mass; that is, because of their weight and some of the physical properties of water, they slow down temperature changes within their environment.

Thus, in the simplest of CRT shipping solutions, cool packs containing warm water are packed around the shipped product in an insulated container. Of course, a specialist packaging supplier will have conducted appropriate qualification testing on the design in the usual pharmaceutical validation process. However, most CRT packaging takes a step up from this and uses the phase change of a specialist material to give a powerful temperaturemaintaining effect.

These specialist PCMs work in the same way as a water-based cool pack works in a cool chain shipping system. In this instance, ice-based cool packs melt to water at 0°C and provide a cooling effect at this constant temperature as they do so. Ice is going through a phase change at this temperature – changing from one state (solid ice) to another (liquid water). Indeed, this is the ‘magic’ of most temperature-controlled shipping options – they use the energy ‘storage’ capability of a phase change to maintain a tight temperature range around them.

Consider a specialist PCM that might be used in a CRT shipping system. A typical PCM used might have a melting point of +20°C – a temperature safely within the +15°C to +25°C shipping temperature range. The PCM material has a latent heat energy at +20°C as the material changes between solid and liquid. In a shipping system, this can be used to keep the internal temperature close to +20°C while the outside environment varies.

There are two approaches to using this phase change material. The first is to prepare it in its liquid state – for our hypothetical material this would mean a little above +20°C in temperature. When the shipping system is exposed to cold external temperatures and this cooling effect travels through the walls of the insulated shipper, the PCM freezes at a constant +20°C, thus maintaining the internal temperature. The payload is then kept in the required +15°C to +25°C environment.

The second approach is the opposite of the first. The phase change material would be prepared in its solid state (a little below +20°C). Now, in the opposite temperature risk situation – in other words, when the shipping systems are exposed to hot external temperatures – it is a heating effect that travels through the walls of the insulated shipper. Yet when this happens, the PCM melts at a constant +20°C, thus maintaining the internal temperature. Again the payload is kept in the required +15°C to +25°C environment.

These two methods of using PCMs are similar to having ‘summer’ and ‘winter’ systems with cool chain solutions. The two options are designed for performance in different external environments. Of course, CRT packaging used in shipping will be sourced from a specialist packaging or logistics provider. They will supply an appropriately validated design with a packing instruction that describes how the PCM eutectic plates should be prepared.

A Risk Management Approach to the Selection of CRT Logistics Solutions

Many specialist CRT packaging solutions can be quite costly, while the risk of product damage through temperature excursion is often only confined to certain shipping routes and times of year. Because of this, a pragmatic approach to purchasing and using CRT logistics can be followed. By making a risk-based assessment of each shipping route, a decision can be made on which specialist logistics option is chosen.

The three options that have been discussed are:

  1. No temperature control – the goods are packed in grouping cartons and sent through a normal logistics process
  2. A climate-controlled vehicle giving a temperature-controlled solution
  3. The use of PCMs in self-contained temperature controlled packaging, providing a temperature-controlled solution

Consider a hypothetical product that is normally stored in an uncontrolled warehouse environment but for which it is undesirable to experience extremes of hot or cold temperature. If this product is to be distributed from the UK to international destinations there will be a variety of temperature risk factors. By assessing these risks, the best logistics solution can be chosen for each eventuality.

In this hypothetical example, consider that it is undesirable for the product to experience temperatures, below 0°C or above +30°C. Table 1 shows possible outcomes from an assessment process on various shipping routes. Different logistics solutions have been proposed depending on the nature of each route. A specialist logistics provider can offer these options to a shipping site. When actually shipping, temperature monitors can be used to add confidence that unexpected environments have not been experienced. They can also be used to validate routes over the seasons to measure actual temperature experiences. Requirements for controlled room temperature packaging and logistics vary over the year. Requirements increase during the winter as colder temperatures give more concern over cold temperature risks. Similarly, some hot emerging market destinations justify a CRT logistics solution in the summer, especially if there are potential delays in an uncontrolled customs warehouse.

Specialist logistics solutions for controlled room temperature shipping are available. For some products and research samples, a CRT option must always be selected as a specific temperature band such as +15°C to +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 a specialist logistics provider, smart decisions based on a risk assessment of the route can be used to ensure the solutions chosen are appropriate and efficient.

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Nathan Barnard is the Cool Chain Manager at Biocair International, a leading specialist courier to the biotechnology, pharmaceutical and scientific research industries. He is responsible for directing and developing Biocair’s temperature controlled logistics services worldwide. This includes improving temperature performance and giving customer support where needed. Prior to Biocair, his experience includes medical device and pharmaceutical packaging roles, in particular for specialist packaging companies who supply cold chain and other temperature-controlled shipping solutions. Email:
Nathan Barnard
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