NEWS: Spring into Cleaning
At Interphex in late March, Bosch Packaging Technology helped pharmaceutical packagers kick off spring with two new approaches to high-tech cleaning and contamination control. The company introduced GKF HiProTect, a fully contained capsule filling system for highly potent or toxic substances, and PreVAS, a disposable dosing system for liquid-filling lines.
Featuring filling and checkweighing in one station, GKF HiProTect maintains all production zones under negative pressure, explained Carl Larson at a media briefing at the show. All controls are built into the unit for reproducible cleaning, including systems for work-in-place and clean-in-place processes. Through one-touch activation, high-pressure nozzles clean the interior of the machine with strong acids, caustic solution, and desalinated water, reports Bosch in a press release.
“There is a need to protect the operator from potent drug substances, yet at the same time, there is a need to eliminate expensive suits,” said Jens Mack, vice president of Bosch’s Pharma Solid Div. “We’ve taken the suit off the operator and added it to the machine,” explained a speaker in a video shown at the event.
Powder, tablets, pellets, liquids, and even combination formats can be handled. A no-cap/no-fill function prevents product loss and contamination inside the machine.
Bosch’s PreVAS is a complete liquid-dosing system for vials, ampules, and syringes that is gamma sterilized and ready to use right out of the bag, explained Jeff Jackson, director of product management at Bosch Pharma U.S. The prevalidated, preassembled, and presterilized product path (hence the name PreVAS) includes a positive-displacement rolling diaphragm pump made from clear pharmaceutical-grade plastic, tubing, and dispensing needles that are guaranteed straight.
PreVAS is fully disposable. Because users either discard or incinerate the system after use, they eliminate the need for cleaning agents that have to be dealt with in wastewater. “The savings are off-line,” says Jackson. Using PreVAS “reduces capital investment, reduces utilities for cleaning, reduces turnaround time, reduces the risk of contamination, and reduces the risk of liability.” If customers have experience using disposable components (like silicone tubing) upstream, they already have the experience with such filings with FDA, he says.
Mack said that trends toward the development of highly potent drugs are in turn driving trends toward true containment solutions as well as disposable components in manufacturing.