Watson-Marlow Bredel has introduced LaserTraceability on its Pumpsil brand of platinum-cured silicone tubing in response to demands from the bio-pharmaceutical industry and the FDA.
Mark Rawet, Tubing Business Manager, explains why processing equipment manufacturers need to adapt processes to meet industry demands.
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.
The ability to demonstrate clear product tracking is a pre-requisite to knowing the true identity and origin of any product. 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, the FDA now requires the bio-pharmaceutical industry to demonstrate not only traceability of all raw materials and ingredients but also any part contacting the product during the manufacturing process.
The component parts of any finished product may undergo separate manufacturing processes in different countries with each manufacturer using a range of equipment in addition to an increasing pool of potential suppliers for parts and materials that makes the issue of traceability very complex.
This has led to manufacturers adapting their processes at each stage of the cycle to meet FDA requirements.
For instance, Watson-Marlow Bredel has introduced LaserTraceability on its Pumpsil brand of platinum-cured silicone tubing to demonstrate clear traceability in manufacturing processes.
LaserTraceability involves the laser etching of the part number, lot number and use-by-date on the silicone tubing to ensure that the product can be traced even when it has been removed from the packaging.
Laser etching eliminates the need for inks or solvents that can potentially contaminate the fluids being transferred through the silicone tubes.
Laser etching has no impact on the life or physical performance of the tube, and cannot be removed by cleaning, solvents or normal use, making it ideally suited to the traceability needs of the bio-pharmaceutical market.