Shaping up for shipping out

Just as cruises and global air travel used to be the preserve of the wealthy, validated temperature controlled shipping systems used to be for the biggest and most well-heeled in the pharmaceutical world.

But UK company Laminar Medica, Europe's largest designer and manufacturer of validated temperature controlled shippers, has brought validated temperature controlled shipping solutions within the reach of most pharma companies.

According to Gee Thomas, Laminar's technical director, distribution chains are getting longer and more temperature sensitive products are being transported within them. For these two reasons Laminar sees its primary tasks as taking cost out of the distribution chain while at the same time improving the performance of shippers. In the past two years alone, the company has introduced new concepts like off-the-shelf validated shippers as well as return-to-base shippers that can be reused many times.

documented protocol

Improving the performance has to mean validation, Thomas says. 'If not shipped using the right packaging solution that ensures that the correct temperature range is sustained at every stage of the journey, a product can very easily denature and lose its efficacy,' says Thomas 'For this reason it is not sufficient to simply design a shipping system, it has to be qualified to a documented validation protocol as well.'

Depending on the complexity of the task, validation procedures can take anything, from two or three weeks to a year to complete, although the average is three to four months. At the conclusion of that process, however, the customer will be able to enjoy corporate peace of mind, having received the optimum solution currently available for ensuring that the products travel at the correct temperature range and reach the end user in perfect condition.

The process begins with identifying the requirements needed to build the correct validation test protocol. This involves considering all relevant factors such as product size, ambient conditions, transit times and cost parameters. From this protocol climatic and environmental tests are undertaken at Laminar's validation facility in Hertfordshire. Here, environmental chambers are programmed to simulate the various ambient temperature profiles that will be encountered by the product packaging during transit. Furthermore, because all test measurements are traceable back to a certified national calibration standard, they can, when combined with ISO9001:2000 accreditation, be used to support dossier submissions to licensing authorities such as the FDA, MHRA and EMEA.

Following the recent installation of two new walk-in chambers (Manufacturing Chemist, October 2003) Laminar's validation laboratory, can now claim to be one of the largest in the world with 10 environmental chambers: five small (1m³) and five walk-in (9m³), plus five conditioning units covering +5°C, -20°C and -40°C.

temperature control

'It's not simply a matter of being able to say that Laminar's is the biggest, even if it is,' stresses Thomas. 'It is about being able to accommodate new customers and providing capacity for existing customers' new projects. These are tending to become more complex, demanding more laboratory time and space.'

Each of the chambers in the Laminar lab is microprocessor-controlled, which allows them to be programmed with a practically infinite number of profiles within ambient temperatures from -20°C to +50°C. Other dedicated chambers offer preconditioning facilities for cool-packs and test products, including -40°C super-freezer, -20°C freezer and 2 x +5°C chillers. 'On the who-is-guarding-the-guards principle each chamber is validated annually by its manufacturer,'says Thomas.

control calibration

Data acquisition in the validation lab is achieved with Grant Squirrel data loggers comprising 8, 12 and 16 channel devices which enable Laminar to map temperatures of even the largest payloads to +0.5°C accuracy. T-type thermocouples are used with these loggers and the devices are triple point calibrated on a monthly basis or as required by the qualification protocol to traceable national standards (UKAS).

According to Thomas, the new capacity also puts more flexibility into the equation. 'It means we can adopt specific procedures requested by our customers - pre- and post-test calibrations, for instance. Our operating specification is ±0.5°C accuracy, 0.1°C resolution.'

Operating under the ISO9001:2000 quality system means that all test work is recorded, traceable and archived accordingly. The BSI as well as Laminar's customers regularly audit the company's conformance. Laminar, says Thomas, welcomes these interventions, which in effect continually validate what is one of the world's largest validation databases.

Thanks to a sustained r&d programme by Laminar Medica, practically every pharma manufacturer can now access validated temperature controlled shipping solutions