A pack for all seasons

Controlling the temperature of pharmaceuticals in transit is big business. Laminar Medica specialises in insulated packaging solutions to ensure that temperature-sensitive drugs arrive in perfect condition

The niche market for insulated packaging for the pharmaceutical and biotechnology sectors was identified a few years ago by Tring-based Laminar Medica, which moved from transit packaging into cold chain shipping containers. It now claims to be the largest manufacturer of this type of packaging in the UK and Europe. The company manufactures all its products on site, enabling it to control the quality of the components, and also carries out all testing and validation on behalf of customers on the premises.

At its Tring plant it can mould in the region of 15-20 different expanded polystyrene (EPS) components, from which it constructs mainly bespoke systems to meet customers' particular requirements. It also manufactures its own Medicool phase change cool packs - water-based blocks that freeze at 0°C, which are used to achieve and maintain a chill temperature within the shipping unit of 2-8°C.

validation protocols

Testing and validation is carried out in the purpose-built technical and validation centre, where the laboratory incorporates six environmental chambers - three large, walk-in units and three smaller units.

The first stage of validation involves sitting down with the customer and drawing up a testing protocol. This is an in-depth process to gain as much information as possible about the project: where the product is going, how much product will be in the container and whether there is a minimum or maximum load. 'We need to know, for example, whether it matters which way up the product is packed, and whether there will be anything else inside the pack. Everything is simulated and calibrated,' said Katrina Bray, marketing manager. 'We try to cover every eventuality to enable us to come up with the most economical system.'

Eventually the optimum design of the shipping unit is decided, including the combination of insulation layers and spacers to keep the product from coming into contact with the cool packs. Bray admits that it would be easy to over-engineer the pack - to come up with a solution that far exceeded the actual requirements of the project. But Laminar Medica's process is aimed at keeping costs down and providing a container that will meet the customer's requirements cost effectively.

testing procedures

To ensure that test conditions mirror as closely as possible those that the product will encounter on its journey, the ambient temperature profile is simulated. Laminar Medica has built up a massive database over many years containing information from shipments sent out to all parts of the globe. 'That helps us to assess what we think the temperature will do in various parts of the world at various times of the year,' Bray explained. 'A lot of the decisions are based on that database as well as on the live tests.'

Testing is carried out using either actual or dummy product from the customer to ensure that the data shows accurately the effect of the journey on the product. And to take this simulation one stage further, Laminar Medica monitors the product itself rather than the air temperature inside the box. 'The two can be very different, and that is where a lot of people tend to trip up,' stressed Bray. Even though the air inside the container may be warmer than the stipulated range of 2-8°C, the product temperature can still be within the parameters. Relying purely on logging the air temperature can lead to perfect product being thrown away unnecessarily 'just to be on the safe side'.

All test measurements are traceable back to certified national calibration standards and, when combined with ISO9001 certification, can be used to support dossier submissions to licensing authorities, including the FDA, MCA and EMEA.

In the past, the company's systems have been almost entirely made-to-measure, but now it has added a range of eight standard, off-the-shelf shipping systems, known as Chilltherm, aimed at customers requiring a quick solution without spending time on developing a bespoke validation protocol. The Chilltherm containers are supplied with validation data and all are tested for minimum and maximum loads and for summer and winter ambient temperatures. The components are supplied on a pallet and are conditioned according to the time of year when they are used.

The latest development is ThermoPorter, a range of flat-pack, reusable shipping systems designed for transporting blood, vaccines, clinical specimens and other temperature-sensitive items. The system is the result of extensive research and can be validated to maintain stable temperatures for multiple openings while in transit.

ThermoPorter is manufactured from three-ply nylon stuffed with padded insulating material, and is said to offer a much greater volume of usable space thanks to its use of vacuum insulation panels - which also keep the weight of the pack to a minimum. The containers are locked together by a system of Velcro strips and have specially designed short handles for ease of carrying.

But for some products - such as whole blood, platelets and blood derivatives, tissue samples, pharmaceutical and biotech products - the issue is one of keeping warm rather than cool, and for these Laminar Medica has launched ActivHeat (shown left). Aimed at products that need to be stored and transported at temperatures of 15-30°C, the device can maintain fine temperature ranges with precise control.

more innovation

ActivHeat consists of a Meditherm insulated container with a thin, flexible heating insert, which comprises a number of sheets which are folded to envelop the product. The reusable sheets are manufactured from a carbon polymer product (CPP) which ensures uniform heating across the sheets to +/-1°C), thereby enabling very accurate temperature control of payload. The heating device can be powered by a low power battery pack or by an external power source.

Nor is this likely to be Laminar Medica's last innovation - research is underway into other phase change materials to widen the range of temperature possibilities. The company is also looking at finding a replacement for dry ice for its Freezetherm deep frozen, off-the-shelf range of shippers, to overcome the concerns about leaks of carbon dioxide in aeroplane holds.

The weather outside may be cold, but things are hotting up in Tring.