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news.The US Food and Drugs Administration (FDA) has approved GEA Lyophil’s VAPOVAC, the latest technology for H2O2 gas sterilization of pharmaceutical freeze dryers.
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The system is ideally suited to pharma applications that require sterile conditions without the stresses and high power usage associated with steam sterilization techniques.
GEA Lyophil said the technology is available both for new plants and as a retrofit for existing installations.
The VAPOVAC sterilizer uses hydrogen peroxide to sterilize equipment under vacuum in a three-stage process: drying, sterilization and aeration.
Only a very small quantity of hydrogen peroxide is used to penetrate the freeze dryer vessels and all associated piping of the equipment, eliminating all residual contamination.
The freeze dryer is then fully vented, leaving no harmful residues.
GEA Lyophil Sales and Marketing director Hubert Kluetsch said not having the FDA approval has held us back until now as so many potential customers were unable to consider technology that did not have the FDA stamp.
GEA Lyophil’s full range of freeze drying products for the pharmaceutical industry include: laboratory freeze dryers, both pilot scale for R&D and small production batches; industrial freeze dryers; and complete freeze dryer systems with Automatic Loading and Unloading Systems (ALUS), integrated isolators, and CIP/SIP skids.