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Mark Rawet, Tubing Business Manager of Watson-Marlow’s Manufacturing Plant in Falmouth, explains why processing equipment manufacturers need to adapt processes to meet industry demands.
Knowing the true identity and origin of a product has never been more important – and the ability to demonstrate clear product tracking has become a pre-requisite. High profile product recalls and increased public awareness of consumer health issues have put traceability firmly on the agenda for retailers and manufacturers in the bio-pharmaceutical industry, as well as others.
Bio-pharmaceutical companies must be able to prove documented control of their products and processes, and must be able to trust their suppliers to do the same.
However, ensuring full traceability doesn’t just refer to the products themselves. The FDA (American Food & Drug Administration) ensured the bio-pharmaceutical industry could demonstrate very clear lot traceability of all raw materials and ingredients first. It has now turned its attention to any parts which contact the product. The question they are 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 component parts of any finished product may undergo separate manufacturing processes in different countries, with each manufacturer using a range of equipment in the process. The globalisation of industry has increased the pool of potential suppliers for parts and materials, adding further complexity to the issue of traceability. With many large players in the biopharmaceutical industry, 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 adapt their processes at each stage of the cycle.
So what are manufacturers doing to meet these demands? In response to the demands from the market and the FDA, Watson-Marlow has introduced LaserTraceability on its Pumpsil brand of platinum-cured silicone tubing. It demonstrates clear traceability in manufacturing processes.
LaserTraceability involves the laser etching of the part number, lot number and use-by-date on the tube. This ensures that 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 has no affect on the life or physical performance of the tube. It cannot be removed by cleaning, solvents or normal use, making it ideally suited to the needs of the bio-pharmaceutical market.
Of course, the issue of traceability extends further than the bio-pharmaceutical industry with regulations within the food industry becoming increasingly stringent. Over the next few years, we can be sure that traceability will continue to be a key issue for manufacturers in all sectors of the processing industry.