Keeping tabs on tubing

Traceability is high on the agenda for the biopharmaceutical industry and the ability to demonstrate clear product tracking has become a prerequisite.

However, ensuring full traceability doesn't just refer to the products themselves, says Mark Rawet, tubing business manager at Watson-Marlow Bredel, the world's largest manufacturer of tube and hose pumps. 'Having ensured the biopharmaceutical industry could demonstrate very clear lot traceability of all raw materials and ingredients, the FDA has turned its attention to any parts that have contact with the product.

'The question they are now putting to biopharmaceutical companies is "So you can trace the product through the process, but how can you prove 100% that you know exactly what has been in contact with the product?"'

The globalisation of industry has increased the pool of potential suppliers for parts and materials, adding further complexity to the issue of traceability. The component parts of any finished product may undergo manufacturing processes in different countries, with each manufacturer using a range of equipment in the process. Global lists of approved suppliers are now commonplace and quality auditing often takes place across borders to ensure that controls are uniform. This drive from the market for stricter 'policing' coupled with increasing demands from the FDA has led to manufacturers being faced with no choice but to act and adapt their processes at each stage of the cycle.

In response to these demands, Watson-Marlow Bredel has introduced LaserTraceability on its Pumpsil brand of platinum-cured silicone tubing in order to demonstrate clear traceabiltily in manufacturing processes. LaserTraceability involves laser etching the part number, lot number and use-by-date onto the tube, ensuring it can be traced even when it has been removed from the packaging. A fine, laser surface etch on the tube means that no inks or solvents are used, which could contaminate the fluids being transferred through the tube. In addition, the laser etch also has no effect on the life or physical performance of the tube and cannot be removed, making it ideally suited to the needs of the biopharmaceutical market.