One of the most exciting advances we keep coming across is disposable manufacturing for biopharmaceutical markets. The world's biggest filtration and separation players have thrown themselves in with single-use products and a “plastic factory mindset” geared to help biopharmaceutical players cut cost; but more importantly, reduce their reliance on human operators at the point of process.
And since personnel contamination is Number 1 on the Parenteral Drug Association's (PDA) list of causes of aseptic processing failures, it could be time for producers to take heed and consider what disposable integration could mean to future yields.
Here's the concept in a nutshell: Once all permanent fluid paths are eliminated, which will propose the principal challenge, the goal would be the development of a completely disposable manufacturing facility, or “plastic factory,” where every process unit could be retooled at the end of each product run.
In this month's Biotechnology/Life Sciences supplement, we offer two visions of “disposable manufacturing.” Millipore's Steve Tingley walks readers through an overview of the ideal plastic factory. Tingley's vision has manufacturers better able to focus their top employees on the actual “process than on preparation and clean up after manufacturing.” He mentions that cost saving is realized through labor reductions, the elimination of steam sterilization, autoclaves and clean-in-place (CIP) utilities that could minimize the size of plants and cut down on validation efforts.
Pall Corp.'s Holly Haughney sharpens the focus on the flourishing single-use products coming to market, touting the ease of use, safety and the ultimate positive effect on contamination control efforts. Haughney stresses safety advantages to such a system because filter, bag, tubing and all related components are manufactured and sterilized as one, eliminating any contamination risks associated with aseptic connections during coupling.
Like their brethren in microelectronics, pharma/biotech readers are stridently continuing their quest to step away from hyper-strict contamination-free ballrooms and concentrate on contamination control at the point-of-use. Are “plastic factories” the answer? It's too soon to tell since integration is not yet widespread. However, these new concepts could prove to be a welcome addition to the contamination control continuum.
Michael A. Levans