Until the late 1990s, Watson-Marlow Bredel sourced all its tubing from third party sub-contract manufacturers. In a move to give us direct control of the quality and delivery of a major element of our product range, we built a major new tubing plant at Falmouth in 1999. We believed a shorter supply chain and SMED principles could be applied to tubing manufacture to improve customer service, and direct control of the manufacture would enable enhanced product quality.

The clean room was built to ISO 146441-1 class 7 (the new standard which replaces the old 'class 10,000' or class J) with a focus to ensure that it was – and remains – a state-of-the-art facility.

The first tubing material produced was premium platinum cured silicone. The primary market for silicone tubing is the bio-pharmaceutical industry, with strong demands in terms of product quality, approvals, traceability and customer service.

As soon as the room had been commissioned and validated, we began a series of tests, extruding and testing a range of raw materials to see which would perform best in our pumps. Once we had selected the best material, we carried on with extrusion trials, making and testing every standard size of silicone tubing that we offer. In total we completed something in excess of 250,000 pump test hours. Following on from this work, we also have an ongoing test programme to ensure that we maintain our tube performance.

In parallel with the test work, we commissioned an extensive validation pack which included all the key biocompatibility data and other information required by the bio-pharmaceutical industry.

Following the first introduction of our 'in house' tubing, we continued to look at the requirements of our customers and in particular those driven by the FDA. Lot traceability is a key issue for anyone involved in the production of end-user product or intermediates. The FDA, having ensured the bio-pharmaceutical industry could demonstrate very clear lot traceability of all raw materials and ingredients, were turning their attention to any product contact parts, such as silicone tubing. The question they put to our customers was "Okay, so you can trace the bag of tubing, but how can you 100% positive that the tubing you are using in that process came from that bag?".

In response to this requirement, Watson-Marlow introduced Lasertraceability® the laser coding the tubing lot numbers, part number and use-by date along the length of the tube. For the first time, users would have complete, indelible lot traceability on the tubing and so there could no longer be a question about whether the lot number paperwork trail was correct. A key additional benefit was that Lasertraceability® does not use any inks or solvents and so there are no potential contaminants introduced on to the tube.

Since introducing Lasertraceability® in September 2002, some other suppliers have introduced laser coded lot numbering on silicone tubing, firm evidence of the real benefit that Lasertraceability® brings to users in the Bio-pharmaceutical market.

Watson-Marlow now supplies silicone tubing to a huge range of customers, including many of the world's leading bio-pharmaceutical companies. Many of these companies have audited our plant in Falmouth, UK, which we operate to cGMP standards within an ISO9001:2000 environment.

Watson-Marlow's silicone sales have continued to grow strongly, driven by a strong combination of features, benefits, service and responsiveness. Many customers have also seen the key benefit of dealing directly with the manufacturer.

Alongside our silicone plant, in 2004 we built another state-of-the art plant the production of Bioprene tubing. Following the same guiding principles as the silicone plant, we ensured that our new tubing facility would produce the highest quality tubing. On-line monitoring systems and control systems ensure the tightest tolerances are maintained and the same operating environment as the silicone plant ensures the plant is designed to meet or exceed the expectations of our bio-pharmaceutical customers.