For GMP-regulated pharmaceutical companies required to decontaminate aseptic material packages, such as vial stopper bags, wrapped components, and syringes, transferred between areas of different classifications.
STERIS Life Sciences has developed a new Vaporized Hydrogen Peroxide VHP decontamination chamber solution for contamination control in aseptic material transfer. A typical application is surface bio-decontamination of pre-sterilized material packages, such as vial stopper bags, wrapped components and syringes.
The DC-A process cycle consists of three distinctive phases:
In the preconditioning phase the chamber air is dehumidified to ensure successful process. In addition to dehumidification the Pre-Conditioning phase lowers the amount of particulates on the load.
VHP Decontamination accomplishes 6-log bioburden reduction of the bio-burden by utilizing STERIS’s non condensing VHP process.
Post–Conditioning aeration removes VHP gas from a chamber by a highly efficient catalyzer that breaks VHP gas into water and oxygen. The chamber door can be opened when VHP concentration inside the chamber is at the safe level.
The unit is controlled Siemens PLC and HMI. It has easy to interface configurable parameters to accommodate multitude of different loads.
Certificates of manufacture/analysis for consumable products by product ID and lot number. (Adobe® Acrobat® Reader required)