Sterility Test Workstation

Overview

The EnGuard Sterility Test Workstation consists of two chambers. The first chamber serves as an airlock where the materials to be tested are placed for sanitization. Sanitization is accomplished either manually or by an automated vapor systems. Sterility testing takes place in the second chamber where a Millipore Steritest Integral 316II can be integrated. Each of the two chambers has a utility panel located on the rear wall.

The overall dimensions of the EnGuard Sterility Test Workstation are 80" wide, 24" deep, by 79" high. The workstation is height adjustable. Note that the workstation requires an additional 24" of width for loading space on the sanitizing chamber end.

Standard Features

This workstation operates under a monitored positive pressure configuration. The framework of this isolator is constructed of 316L stainless steel. Viewing areas are molded from the best quality scratch resistant engineered plastic. All gasket materials are FDA approved. Each of the two chambers has an independent air handling system. In these airflow systems both entering and discharging air is HEPA filtered. During the aeration cycle, the air is discharged through a local building exhaust system. InteriorHEPA filter openings are covered by a cleanable membrane that protects the HEPA filter and also serves as a pre-filter. Interior surfaces are smooth and easily cleanable with coved junctures of ceiling, walls and floor. All welds are ground smooth and meet cGMP cleaning standards.

Advantages

• Significantly lower operating cost
• Faster cycle times
• Portable for relocation and storage
• Integrated testing and biodecontamination systems
• Complete validation package available