The Importance Of Post-Cured Tubing In Sanitary Applications

Silicone tubing plays a key role in pharmaceutical and biopharmaceutical manufacturing processes and, as with the raw chemical ingredients and excipients used to produce drugs and medicines, is similarly subject to stringent quality controls. Meeting the requirements of regulatory authorities like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) is always uppermost in pharmaceutical manufacturer's minds.

New research has highlighted concern about failures in the post-curing process of silicone tubing production. One of the key concerns is the migrating of silicon from the tubing into the final product, a phenomenon that would bring about harmful consequences for patients. In recent years, a number of studies on leachables for medical device and pharmaceutical products have been undertaken.

Now, new research from the independent specialist laboratory Toxicon indicates that pharmaceutical manufacturers may unknowingly be using tubing capable of generating leachables during the production process. Toxicon carried out tests on three different types of platinum-cured tubing from three different suppliers, and found that two of the three tested produced levels of leachables in the product that many pharmaceutical manufacturers did not anticipate being present.