VAPOVAC™ - New FDA compliant H2O2 sterilization system for pharmaceutical freeze dryers

VAPOVAC™ is the latest technology for H₂O₂ gas sterilization of pharmaceutical cGMP freeze dryers. GEA Lyophil has recently received a FDA Letter of Non-Objection for the new H₂O₂ sterilization system, VAPOVAC™, for pharmaceutical freeze dryers.

With the FDA Letter of Non-Objection GEA Lyophil is now allowed to market the VAPOVAC™ system worldwide. The system is ideally suited to pharmaceutical applications that require sterile conditions without the stress and fatigue associated with normal steam sterilization techniques.

For many years pharmaceutical freeze dryers have been fitted with SIP systems, (Sterilization in Place) that use steam as the sterilizing medium. However, steam sterilization subjects the dryer to extreme ranges of pressure and temperature that the chamber, condenser and related piping must be built to withstand.

GEA Lyophil freeze dryer with an FDA compliant VAPOVAC™ H2O2 (hydrogen peroxide) sterilization system

With VAPOVAC™, GEA Lyophil has developed a less expensive option using H₂O₂ (vaporized hydrogen peroxide) which is faster, safer, more efficient and easier on the environment than steam. The technology is available both for new plants and as a retrofit for existing installations.

The VAPOVAC™ sterilizer uses vaporized hydrogen peroxide (VHP) to sterilize equipment under vacuum in a three-stage process: drying, sterilization and aeration (venting). Only a very small quantity of hydrogen peroxide is dispersed in the freeze dryer vessels and all associated piping of the equipment. This method effectively eliminates all residual contamination. The freeze dryer is then fully vented, leaving no harmful residues.

GEA Lyophil is the only company to offer this technology. Hubert Kluetsch, Director of Sales and Marketing for the company, said that the FDA approval was very important. "Not having the FDA acceptance has held us back until now as so many potential customers were unable to consider technology that did not have the FDA stamp," he said. "Now that the FDA has given VAPOVAC™ its seal of approval, many new markets will be open for us."

VAPOVAC™ is just one of the freeze drying products supplied by GEA Lyophil for the pharmaceutical and biotechnology industries. The range 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.

The VAPOVAC™ technology fulfill all conditions for the sterilization of machines in pharmaceutical industry, the acknowledgment took place via the FDA. It is guaranteed that the process can be validated and leads to the appropriate sterilization result (SAL=10 exp.6).

For further business information contact:

H. McCoy Knight, National Sales Manager - Pharma Systems
GEA Process Engineering Inc.
GEA Pharma Systems
9165 Rumsey Road, Columbia, Maryland, 21045
Office: +410-997-6608, Fax: +410-997-5021
mccoy.knight@geagroup.com
www.niroinc.com

Hubert Kluetsch - Director Sales and Marketing
GEA Lyophil GmbH
Kalscheurener Str. 92, 50354 Huerth, Germany
Tel: +49 (0) 2233/6999-220 Fax: +49 (0) 2233/6999-8220
lyophil@geagroup.com
www.geapharmasystems.com