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Commercializing vacuum-microwave drying for pharmaceuticals

By Mary Page Bailey |

Vacuum-microwave drying for pharmaceuticals is much faster than other techniques, such as freeze drying or air drying, but the difficulty in achieving homogenous microwave-energy distribution under vacuum conditions has made it difficult to scale up for commercial manufacturing. “What tends to happen is a concentration of energy, and plasma discharge can readily occur, which can burn the product and damage equipment,” explains Brent Charleton, president and chief executive officer of EnWave Corp. (Vancouver, B.C., Canada; www.enwave.net). EnWave has developed proprietary technology that minimizes the probability of plasma discharge at varying vacuum levels, providing an even, controllable drying process. The technology has already been deployed into the food sector, and EnWave has been working with Merck KGaA (Darmstadt, Germany; www.merck.com) to fine-tune a pilot unit designed for the biopharmaceuticals sector, which Charleton says is the first continuous vacuum-microwave machine that meets Good Manufacturing Practice (GMP) regulations.

“We can dry many vaccines simultaneously in a continuous fashion. The primary goal is to eliminate the cold-chain storage requirement for that product and still maintain efficacy,” says Charleton. Now, EnWave has partnered with GEA Lyophil GmbH, part of GEA Group AG (Düsseldorf, Germany; www.gea.com), to evaluate scaleup and commercialization options on the basis of the Merck pilot unit. Right now, GEA and EnWave are working to ensure that large-scale units can meet the stringent traceability and repeatability requirements demanded for pharmaceutical products.

In vacuum-microwave dryers, product enters a vacuum chamber where an array of magnetrons elicits a predetermined amount of microwave energy based on maintaining a certain temperature profile to reach the desired decrease in moisture. Microwave energy is absorbed by organic materials on the first pass, and unabsorbed energy is either reflected off the stainless-steel vessel interior and back through the product load to maximize absorption, or absorbed by a water load to eliminate the propensity for plasma discharge to occur. Typically, says Charleton, 85–90% of energy is absorbed by the product load.

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