Clarifying The Status Of Extractables And Leachables

By Weibing Ding and Jerold Martin, Pall Life Sciences

There are many reasons why pharmaceutical manufacturers may either embrace the concept of single-use manufacturing or reject it. Those embracing it may see benefits in features such as elimination of cleaning and reducing the risk of cross-contamination, or perhaps a CMO may require greater flexibility and less downtime for a multi-product manufacturing facility.

Those rejecting the concept may be operating at a scale beyond the reach of current single-use systems, or possibly some of the unit operations are not available in single-use format. One concern that is often raised regardless of application is the issue of extractables and leachables.