Sophisticated Cleaning Methods: Approaches to Consider When Manufacturing Multiple Drug Formats

10/1/10

Sophisticated Cleaning Methods: Approaches to Consider When Manufacturing Multiple Drug Formats
Contract Pharma, October 2010

It is vital for the pharmaceutical manufacturing industry to effectively utilize fixed capital assets. Depending upon available equipment, contract manufacturers may choose to leverage their assets by producing multiple dosage formats and products on the same equipment train as opposed to purchasing and installing additional dedicated production lines for each format. In these cases, a robust cleaning approach addressing the compliance aspects and the need for increased manufacturing flexibility must be in place to eliminate the risk of cross-contamination while ensuring product safety. By treating the cleaning process as a strategic imperative — in both the development of an approach for new compounds and in the ongoing implementation of established approaches — it becomes an enabling element for successful and efficient project execution.

This article provides an overview of a multi-drug platform  manufacturing process, the potential cleaning implications of producing multiple dose formats on the same equipment train (ranging from oral and topical dissolvable films to adhesives and transdermal drug delivery systems), and how adhering to the three pillars of cleaning — matrix, minimizing and proceduralize — provides manufacturing flexibility to expand the product portfolio.