By Nigel J. Smart PhD, Managing Partner, Smart Consulting Group
Published on PharmaQuality.com in their April/May 2012 Issue
Take steps to limit undesirable effects
Leachables and extractables have become a significant driver in the potential application of single-use and disposable systems. The increase in industry activity associated with these systems and products reflects their perceived relevance and importance for biopharmaceutical drug manufacturing.
Issues connected with the use of leachables and extractables with various plastics and polymers have been discussed for more than 25 years in the pharmaceutical industry, where products have been in widespread use and have been associated with a variety of applications. Many applications have included use in water-based systems such as syringes and various other sealing components, so there is a long history with regulatory authorities such as the FDA.